Latest news with #REDEFINE
Medscape
5 days ago
- Health
- Medscape
ADA 2025: Clinical Trial Data on Incretin Therapies
This transcript has been edited for clarity. At the ADA meetings this year, incretin therapies were a big topic. There were many, many different studies presented on all sorts of new drugs and older drugs, and a large amount of interest in this. What I'm going to try to do is make it simple, and you're going to have to forgive me because many of these drugs have names that are almost impossible to pronounce. As far as I can tell, there were three main areas that involved incretins. One was newer agents that were different combinations of different kinds of drugs. I'm going to touch on those main areas where there were differences. The second is in terms of the forms for delivery, specifically a new oral form of incretin therapy that might be easier for patients to take. Third, longer duration of activity of these agents that might make it even easier for our patients to adhere to. First, I'm going to go to different combinations. The first is CagriSema, which is semaglutide plus cagrilintide, which is a long-acting human amylin analog. We all were familiar with amylin from a long while ago, as we had pramlintide. This takes that amylin analog and mixes it with a dose of 2.4 mg of semaglutide. The studies that they did are called REDEFINE, and they presented the full results of the phase 3 REDEFINE trials. In most of the studies on these newer agents, they basically study them in people who are overweight or obese without type 2 diabetes, as well as in people who are overweight or obese with type 2 diabetes. REDEFINE 1 looked at 3417 people who were overweight or obese and who didn't have type 2 diabetes. They saw 20% weight loss with this new agent compared to 15% with semaglutide 2.4 mg, or 12% weight loss with cagrilintide alone. In REDEFINE 2, there were 1206 people with obesity and type 2 diabetes compared to placebo. CagriSema conferred a 13.7% weight loss vs 3.4% with placebo. That's fairly standard for many of these drugs. You get weight loss and A1c reduction, and it's always a bit more in people without diabetes than those who have diabetes. Moving on to the next combination. There was the DREAMS-1 trial, looking at a once-weekly GLP-1 receptor agonist combined with a glucagon receptor agonist, which is called mazdutide. It was studied in people in China with type 2 diabetes. This showed a nice A1c reduction and significant weight loss at 24 weeks. This was a study in 319 individuals who were living in China. They had a number of different arms to this study, so they had a 4-mg dose, a 6-mg dose, and placebo. The study lasted for 24 weeks, and they saw A1c reductions of 1.4%-2%. There was weight loss that varied depending on the dose, at 5.6% or 7.8% in the two different arms. There were similar side effects. I think one of the truths of all of these trials is that the GI side effects occur with nearly all of these agents, some to a greater degree than others, but those were the major side effects in terms of this agent. They're now studying it in other individuals with type 2 diabetes. They compared it to dulaglutide and found a greater A1c reduction than with dulaglutide in one trial. They're also looking at it for weight loss in people without diabetes. There are a number of trials that are ongoing that will give us more data in terms of what this combination does in people with obesity and type 2 diabetes. The next trial is one that I find oddly fascinating, which is called the BELIEVE trial. Believe it or not, this is a trial in which they took semaglutide and mixed it with a monoclonal antibody that blocks activin type II receptors, with the hopes that that will improve muscle mass, maintain lean body mass, and decrease fat mass as people lose weight with this combination. They studied it in people who were living with obesity or overweight without type 2 diabetes, and they basically had a number of different comparisons. The monoclonal antibody is called bimagrumab. It's something that I'm not familiar with, but it was really interesting in terms of its effect. They had a number of different groups: a placebo group, a low-dose bimagrumab group, a high-dose bimagrumab group, a low-dose semaglutide group, and a high-dose semaglutide group, and then they had four different combination groups with low-dose or high-dose bimagrumab. They looked at all of these different permutations in a study sample size that was 507 individuals. They were hoping to see less loss of lean body mass, and they basically showed this. There was a 7.9% reduction in lean body mass with semaglutide alone, but if you gave them the monoclonal antibody, there was a 2.3% gain in lean body mass. When you combined the monoclonal antibody with semaglutide, you got a lesser reduction in lean body mass, a 2.6% reduction, which was compared to the 7.9% reduction with semaglutide alone. This is hopeful in the sense that this specific combination helps people lose less lean body mass. There were a whole bunch of other analyses they did to see about people being stronger and feeling better. It really does matter to not lose so much lean body mass. I'm still old fashioned and I really want to encourage people to exercise and eat well in order to help preserve lean body mass. We'll see what happens with this. I think it's a fascinating concept, but I also don't want to forget about lifestyle. The next trial was called ACHIEVE-1, and this was looking at an oral form of a GLP-1 receptor agonist known as orforglipron. They studied this in people with type 2 diabetes. What's different about this is that this is a small molecule. It's not a peptide GLP-1, so it's really easy to give. It's like any old pill that people take, so it doesn't have restrictions around how much water and when it's taken, etc. They did see benefit in terms of A1c reduction, some weight loss, about 8%, and it seemed like it worked, but it did have GI side effects and it didn't cause the same sort of A1c reduction or weight loss we see with some of the other injectable compounds. Still, it might be an interesting first step for people as they get used to GLP-1 receptor agonist therapy, and it may be easier for patients to take. The final compound I'm going to discuss is MariTide. This is a compound that is a GLP-1 receptor agonist and a GIP antagonist. This is a once-a-month agent. This was a 52-week trial in individuals who were obese or overweight without type 2 diabetes. They basically had three different doses they were studying and they did a bunch of different dosing frequencies. It seemed to me to be effective in terms of weight loss, as most of these drugs are, but it did have an incredibly high rate of GI side effects. When you look at that study in individuals without type 2 diabetes, the rates of nausea and vomiting were really high. At baseline, 25% of placebo patients reported nausea. In the treatment group, nausea was reported in 77%-87% of participants and vomiting was reported in 68%-92%. It usually occurred after the very first dose of the drug, with an incidence decreasing over time. I've never used a drug that had such a high rate of vomiting — nausea, potentially, but not vomiting. GI side effects were the main reason for people stopping it, and 14%-29% of individuals discontinued the drug due to adverse events. They also did a study in people with type 2 diabetes. It's interesting because they used a different survey to assess GI side effects, but they still had a very high rate of GI side effects, at 94% in the MariTide group vs 81% in the placebo group. Again, the most common GI side effects were nausea, vomiting, constipation, and diarrhea. Nausea rates ranged from 41% to 59% of people taking the MariTide, with vomiting in 45%-75% of participants. These GI side effects are really clear here, and I don't know that this is going to be something people are going to want to take. Once a month is nice, but it's not fun to vomit. I think it depends on how quickly people habituate to this and how one goes up on the dose. These GI side effects are an issue for all of us and our patients as we prescribe these drugs. I tend to start as low as I possibly can. I'm a fan of microdosing as much as possible to get people to tolerate these drugs because I think that the incretin class of drugs is so beneficial, not only in terms of glucose and weight loss, but also in its nonglycemic effects. I also don't want people to lose weight too fast because I think that it isn't healthy. I know that there are studies that are coming out that show that there are people who respond by very rapid weight loss, more commonly in women than in men. I think we need to be mindful of how we use these drugs, how quickly people lose weight, and how we encourage people in terms of leading a healthier lifestyle to avoid some of the side effects that can be associated with that sort of rapid weight loss. This has been Dr Anne Peters for Medscape.
Cision Canada
24-06-2025
- Health
- Cision Canada
CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM Français
Data presented simultaneously at the American Diabetes Association's ® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss intervention. 1 When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks. 1* The REDEFINE clinical program is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 11. 2 MISSISSAUGA, ON, June 24, 2025 /CNW/ - This week, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes. 1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo. 1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented during a scientific symposium at the American Diabetes Association's (ADA) 85th Scientific Sessions and published in NEJM. Dr. Harpreet Bajaj, Medical Director of Endocrine and Metabolic Research at LMC Healthcare/Centricity Research in Canada and clinical investigator on REDEFINE 2, stated: "In the newly published primary results of REDEFINE 1 and 2 trials, CagriSema, a dual-agonist (incretin and amylin), led to incremental benefits on weight loss and glucose levels compared to semaglutide alone, representing a new era for the next generation of obesity medications. The average weight reduction of over 20% from baseline in REDEFINE 1 among participants with overweight or obesity is very promising. The weight loss in REDEFINE 2, along with over 80% * of the participants achieving HbA1C target of ≤6.5% among participants with type 2 diabetes, marks a significant scientific advancement for Canadians living with obesity who require support beyond currently available GLP-1 RAs. These results are especially relevant to real-world practices, considering the flexibility in both the study protocols." CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment. 1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group. 1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m 2) at the end of treatment, from a mean BMI of 38 kg/m 2 at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks. 1 Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%. * Additionally, 23.1% lost ≥30% of their body weight. 1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction. 1 ** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively. 1 Safety data generated in the REDEFINE 1 and 2 trials was comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 5.9% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2. 1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo) including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity. 1 Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM. 3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo. 3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo. 3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by > 5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.8% vs. 2.4%), and ≥20% (22.9% vs. 0.5%). 3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1. 3 The REDEFINE clinical program will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. About CagriSema CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. About the REDEFINE clinical trial program REDEFINE is a phase 3 clinical development program with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. 1 REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight. 3 Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2. About Obesity in Canada Over 8 million Canadian adults are living with obesity, and many require support to effectively manage their condition. 4 The prevalence of obesity, which increases the risk of serious chronic illness, has grown over the last two decades. 4,5 Obesity is not a personal failure or a lack of willpower—obesity is a chronic disease. 6 Despite its widespread impact, obesity often goes untreated, leading to significant personal, societal, and economic consequences. 7 Just like other chronic diseases, obesity requires long-term management. 8 About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. SOURCE Novo Nordisk Canada Inc.
Malaysian Reserve
22-06-2025
- Health
- Malaysian Reserve
CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM
Data presented simultaneously at the American Diabetes Association's® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions1 When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks1* The REDEFINE clinical program is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 112 PLAINSBORO, N.J., June 22, 2025 /PRNewswire/ — Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association's® (ADA) 85th Scientific Sessions and published in NEJM. 'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'These results reinforce our confidence in CagriSema and we continue to study the potential of this combination through the REDEFINE trials.' CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group (estimated difference [95% CI] -20.4 [-21.1 to -19.7]; p<0.001) if all patients adhered to treatment.1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group (estimated difference [95% CI] -17.3 [-18.1 to -16.6]; p<0.001).1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI <30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment. In the placebo group, 10.2% reached that threshold at 68 weeks.1 Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body-weight reduction of ≥25% ([95% CI] 39.5 (37.1 to 41.9); p<0.001).* Additionally, 23.1% lost ≥30% of their body weight ([95% CI] 22.7 (20.7 to 24.7); p<0.001).1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction ([95% CI] 33.7 (31.5 to 35.9); p<0.001) and 19.3% achieved ≥30% body-weight reduction ([95% CI] 18.9 (17.1 to 20.7); p<0.001).1** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus -5.7% and -4.3% for the placebo group, respectively. 'In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,' said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. 'Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight. These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.' Safety data generated in the REDEFINE 1 and 2 trials was comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs 39.9% with placebo) including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%), vomiting (26.1% vs 4.1%) and were mostly transient and mild-to-moderate in severity.1 Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM.3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was -15.7% with CagriSema versus -3.1% with placebo (estimated difference [95% CI] -12.6% [-13.4 to -11.7]; p<0.001).3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was -13.7% with CagriSema versus -3.4% with placebo (estimated difference [95% CI] -10.4% [-11.2 to -9.5]; p<0.001).3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by >5% (83.6% vs 30.8% of participants; p<0.001), ≥10% (65.6% vs 10.3%), ≥15% (43.9% vs 2.4%), and ≥20% (22.9% vs 0.5%; p<0.001).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3 The REDEFINE clinical program will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. * Based on the trial product estimand: this estimand estimates what the effect would be if all participants adhered to treatment** Based on the treatment policy estimand: treatment effect regardless of treatment adherence About CagriSemaCagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. CagriSema is not approved in the US for weight loss. About the REDEFINE clinical trial programREDEFINE is a phase 3 clinical development program with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a 68-week, double-blind, placebo- and active-controlled efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 was a double-blind, randomized, placebo-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight. Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2. About obesityObesity is a serious chronic, progressive, and complex disease that requires long-term management.4-6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.9,10 In the US, about 40% of adults live with obesity.11 About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit Facebook, Instagram, and X. Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at Contacts for further information Media: Liz Skrbkova (US)+1 609 917 0632USMediaRelations@ Ambre James-Brown (Global)+45 3079 9289Globalmedia@ Investors: Frederik Taylor Pitter (US)+1 609 613 0568fptr@ Jacob Martin Wiborg Rode (Global)+45 3075 5956jrde@ Sina Meyer (Global)+45 3079 6656 azey@ Ida Schaap Melvold (Global)+45 3077 5649 idmg@ Max Ung (Global)+45 3077 6414mxun@ References: Garvey T, Blüher M, Contreras C, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;10.1056/NEJMoa2502081. A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term. Last Accessed: June 2025. Available at: Davies M, Bajaj H, Broholm C, et al. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025;10.1056/NEJMoa2502082. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed June 2025. Available at:
Business Upturn
22-06-2025
- Health
- Business Upturn
Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine
By GlobeNewswire Published on June 22, 2025, 18:00 IST Data presented simultaneously at the American Diabetes Association's ® 85 th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions 1 85 Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks 1 * The REDEFINE clinical programme is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 112 Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association's (ADA) 85th Scientific Sessions and published in NEJM . 'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.' CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.1 Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%.* Additionally, 23.1% lost ≥30% of their body weight.1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction.1** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively.1 'In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,' said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. 'Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight. These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.' Safety data generated in the REDEFINE 1 and 2 trials were comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo), including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity.1 Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM .3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo.3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo.3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by > 5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%;).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3 The REDEFINE clinical programme will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. * Based on the trial product estimand; this estimand estimates what the effect would be if all participants adhered to treatment ** Based on the treatment policy estimand: treatment effect regardless of treatment adherence About CagriSema CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. About the REDEFINE clinical trial programme REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight. Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2. About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.4–6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8 About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information References: Garvey WT, Blüher MD, Contreras CKO, et al. CagriSema in Adults with Overweight or Obesity. New England Journal of Medicine 2025. doi: 10.1056/NEJMoa2502081 A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term. Last Accessed: June 2025. Available at: Davies MJ, Harpreet S, Bajaj MD, et al. CagriSema in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity . 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev . 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract . 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
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22-06-2025
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Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine
Data presented simultaneously at the American Diabetes Association's® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions1 When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks1* The REDEFINE clinical programme is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 112 Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association's (ADA) 85th Scientific Sessions and published in NEJM. 'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.' CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.1 Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%.* Additionally, 23.1% lost ≥30% of their body weight.1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction.1** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively.1 "In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,' said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. 'Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight. These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.' Safety data generated in the REDEFINE 1 and 2 trials were comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo), including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity.1 Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM.3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo.3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo.3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by >5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%;).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3 The REDEFINE clinical programme will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. * Based on the trial product estimand; this estimand estimates what the effect would be if all participants adhered to treatment ** Based on the treatment policy estimand: treatment effect regardless of treatment adherence About CagriSemaCagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. About the REDEFINE clinical trial programmeREDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight. Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2. About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.4-6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8 Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289 abmo@ Liz Skrbkova (US) +1 609 917 0632 lzsk@ Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung +45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568 fptr@ References: Garvey WT, Blüher MD, Contreras CKO, et al. CagriSema in Adults with Overweight or Obesity. New England Journal of Medicine 2025. doi: 10.1056/NEJMoa2502081 A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term. Last Accessed: June 2025. Available at: Davies MJ, Harpreet S, Bajaj MD, et al. CagriSema in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Attachment PR250622-ADA-CagriSema
