Latest news with #GLP1RA
Medscape
6 days ago
- Health
- Medscape
GLP-1 RAs Protective Against Stroke, Neurodegeneration?
TOPLINE: Use of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), particularly semaglutide and tirzepatide, was associated with a 37% reduced risk for dementia and a 19% reduced risk for ischemic stroke in adults with type 2 diabetes (T2D) and obesity compared to the use of other antidiabetic drugs in a new retrospective cohort study. The neuroprotective effects of GLP-1 RAs were more pronounced in older adults, women, and those with a BMI of 30-40. METHODOLOGY: Investigators analyzed data on more than 60,000 adults aged 40 years or older with T2D and obesity and without type 1 diabetes or preexisting neurodegenerative or cerebrovascular diseases, obtained from electronic health records between 2017 and 2024. After propensity-score matching, participants receiving semaglutide or tirzepatide were assigned to the GLP-1 RA group (n = 30,430; mean age, 58 years; 50% women; 56% White individuals), and those receiving biguanides, sulfonylureas, alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 inhibitors, and SGLT2 inhibitors were assigned to the 'other antidiabetic drug' group (n = 30,430; mean age, 58 years; 51% women; 56% White individuals). Primary outcomes were the incidence of new‐onset neurodegenerative diseases (dementia, Parkinson's disease, and mild cognitive impairment) and cerebrovascular diseases (ischemic stroke and intracerebral hemorrhage). The secondary outcome was all-cause mortality. TAKEAWAY: Patients taking GLP-1 RAs had a significantly lower risk for dementia (hazard ratio [HR], 0.63), ischemic stroke (HR, 0.81), and all-cause mortality (HR, 0.70) than those taking other antidiabetic drugs. Compared with use of other antidiabetic drugs, use of semaglutide was associated with reduced risk for dementia (HR, 0.63), whereas use of tirzepatide was associated with reduced risk for stroke (HR, 0.69) and all-cause mortality (HR, 0.48). No significant differences in risk for Parkinson's disease or intracerebral hemorrhage were observed between the GLP-1 RA group and the other antidiabetic group. The neuroprotective effects of GLP-1 RAs were more pronounced in women (HR, 0.85), adults aged 60 years or older (HR, 0.85), White individuals (HR, 0.86), and those with a BMI of 30-40 (HR, 0.82). IN PRACTICE: 'These findings suggest that semaglutide and tirzepatide may offer neuroprotective and cerebrovascular benefits beyond glycemic control, potentially improving long-term cognitive and survival outcomes in adults with T2D and obesity,' the investigators wrote. 'If shown to be protective for neurodegenerative diseases in future trials, GLP-1 RAs could potentially be used clinically in disease prevention in the future,' Sarah Marzi, PhD, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, England, said in an online comment. Marzi was not involved with the current research. SOURCE: The study was led by Huan-Tang Lin, MD, PhD, Chang Gung Memorial Hospital, Taoyuan, Taiwan. It was published online on July 15 in JAMA Network Open. LIMITATIONS: As an observational study, residual confounding from unmeasured factors such as frailty or functional status could not be excluded, potentially introducing healthy user or selection bias. The database used lacked biomarker data, genetic profiles, and neuroimaging assessments, limiting further mechanistic interpretations. The analysis did not account for death as a competing risk. Additionally, medication exposure was inferred from prescriptions without confirmation of actual adherence or accurate drug doses. DISCLOSURES: The study was funded by the Ministry of Science and Technology, Taiwan, and the Chang Gung Memorial Hospital. The investigators reported having no relevant conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Yahoo
21-06-2025
- Health
- Yahoo
Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association's 85th Scientific Sessions
In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly treatment in patients with type 2 diabetes mellitus (T2DM), with significant HbA1c reductions alongside comprehensive benefits for body weight, blood pressure and blood lipid profiles. In a Phase 2b clinical trial, the bofanglutide injection showed superior HbA1c and body weight reduction than semaglutide (Ozempic®) after 24 weeks of bi-weekly treatment in patients with T2DM, along with an acceptable safety and tolerability profile. In a Phase 2 clinical trial, the once-weekly insulin GZR4 injection demonstrated comparable efficacy and safety profiles in patients with T2DM after 16 weeks of treatment. Notably, GZR4 injection achieved superior HbA1c reduction in patients with inadequate glycemic control on prior basal insulin therapy compared to once-daily insulin degludec (Tresiba®). BEIJING and BRIDGEWATER, N.J., June 21, 2025 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, stock code: announced that the company presented multiple Phase 2 clinical study results of ultra-long-acting GLP-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection and once-weekly basal insulin analog GZR4 injection during a poster presentation at the American Diabetes Association (ADA)'s 85th Scientific Sessions. Statement: Bofanglutide injection and GZR4 injection are investigational drugs that have not yet been launched in any country. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. Bofanglutide injection: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bofanglutide (GZR18) Injection in Chinese Patients with Type 2 Diabetes Mellitus (T2DM) In this Phase 2a clinical trial (NCT06256523), 36 adults with T2DM who had inadequate glycemic control through diet and exercise and/or irregular use of antidiabetic medications, were randomized to receive either bofanglutide injection (N=27) or placebo (N=9) once weekly (QW) for 23 weeks, with a dose escalating from 1.5 mg to 13 mg. The key efficacy endpoint was HbA1c change from baseline to week 23. After 23 weeks of treatment, the mean HbA1c change from baseline in the bofanglutide groups was -1.81% compared to 0.12% in the placebo group, with an estimated treatment difference of -1.93% points*. The proportion of participants achieving an HbA1c target of <7.0% and ≤6.5% was 57.7% and 46.2%, respectively, compared to zero in the placebo group. In terms of weight management, participants treated with bofanglutide experienced a mean reduction in body weight of 6.92 kg from baseline, corresponding to a 9.3% decrease, compared to a minimal reduction of 1.2% in the placebo group. Furthermore, bofanglutide showed comprehensive improvements over placebo in multiple metabolic parameters, including fasting plasma glucose (FPG), glycated albumin (GA), waist circumference (WC), blood pressure, and lipid profiles. In terms of safety, bofanglutide was well tolerated in patients with T2DM. Consistent with known GLP-1 RAs, the most common adverse events were gastrointestinal-related, primarily observed during the early dose-escalation period with mostly mild to moderate in severity. No hypoglycemic events or investigational product-related serious adverse events were reported during the study. Bofanglutide injection: A Multicenter, Randomized, Open-label, Active comparator-controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of bofanglutide Injection versus Semaglutide (Ozempic®) in Chinese Patients with T2DM In this Phase 2b clinical trial (NCT06256549), a total of 272 eligible Chinese patients with T2DM, who had inadequate glycemic control either after lifestyle intervention or despite stable use of oral antidiabetic drugs (OADs) for at least 3 months, were randomized to receive bi-weekly (Q2W) 12 mg (N=55), 18 mg (N=54), 24 mg (N=55) bofanglutide injections, or once-weekly (QW) 24 mg (N=54) bofanglutide injections, or 1 mg semaglutide (Ozempic®, N=54) for 24 weeks of treatment, including the dose-escalation period. The primary endpoint was HbA1c change from baseline to week 24. After 24 weeks of treatment, the mean reductions in HbA1c from baseline were 1.87%, 2.28%, and 1.94% in the bofanglutide groups at 12 mg, 18 mg, and 24 mg Q2W, respectively, and -2.32% in the 24 mg QW group. All these treatment regimens showed greater HbA1c reductions compared to the semaglutide group (-1.60%), with the 18 mg Q2W and 24 mg QW bofanglutide groups demonstrating statistically significant superiority (p<0.001)*. Among drug-naïve patients with inadequate glycemic control despite lifestyle interventions, the 18 mg Q2W bofanglutide group achieved a mean HbA1c reduction of 2.98%, which was significantly greater than that observed with semaglutide (-2.04%; p<0.001)*. The proportions of patients achieving HbA1c target of <7.0% were 63.0% to 73.6% in the Q2W bofanglutide group, 75.0% in the QW bofanglutide group, and 70.0% in the semaglutide group. For the HbA1c ≤6.5% target, the corresponding proportions were 58.2% to 67.9%, 69.2%, and 62.0%, respectively. Furthermore, the mean change in body weight for all bofanglutide groups from baseline to week 24 ranged from -4.26 to -6.54 kg, compared to -3.25 kg in the semaglutide group*. Bofanglutide also greatly improved FPG, blood pressure, lipid profiles, and other metabolic parameters. In this study, bofanglutide was generally well tolerated, with safety and tolerability consistent with other known GLP-1 RAs. The most common adverse events were gastrointestinal-related, mostly mild to moderate in severity, and no severe hypoglycemic events were observed. GZR4 injection: A Multicenter, Randomized, Open-label, Active-controlled, Treat-to-target Phase 2 Clinical Study Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin degludec (IDeg, Tresiba®) in Chinese patients with T2DM This Phase 2 clinical study (NCT06202079) enrolled a total of 83 Chinese patients with T2DM who had inadequate glycemic control on OADs (Part A), and 96 patients with inadequate control on OADs combined with basal insulin therapy (Part B). Participants were randomized to receive QW GZR4 injection (Part A: N=42; Part B: N=41) or once-daily IDeg (Tresiba®) injection (Part A: N=48; Part B: N=48) for 16 weeks of treatment. The primary efficacy endpoint was the change in HbA1c from baseline to week 16. After 16 weeks of treatment, in patients from Part A, the mean change in HbA1c was comparable between GZR4 groups and IDeg groups (−1.50% versus -1.48%, p = 0.90). The proportion of participants achieving HbA1c target of <7.0% was 59.5% in the GZR4 group and 70.7% in the IDeg group, while the proportion achieving HbA1c target of ≤6.5% was 38.1% and 29.3%, respectively. In patients from Part B, GZR4 demonstrated significantly greater HbA1c reduction compared to IDeg (-1.26% vs -0.87%; p<0.01), with a higher proportion of patients achieving HbA1c targets of <7.0% and ≤6.5% (52.1% vs 29.2%; 25.0% vs 10.4%). In addition, improvements from baseline in FPG and time in range (TIR) were comparable between the GZR4 group and IDeg group. GZR4 achieved effective glycemic control without the need for a loading dose at the first administration, while the total weekly insulin dosage (mole) for GZR4 was approximately 40–50% of that for IDeg (p<0.001). In terms of safety, the incidence of adverse events was similar between the two groups. No severe hypoglycemic events or investigational product-related serious adverse events were reported during the study. * The clinical data were presented as mean (SE) value. The detailed results of the above Phase 2 clinical study will be published in a peer-reviewed journal. Conclusion and Future Direction The latest clinical results presented at this year's ADA conference highlight Gan & Lee Pharmaceuticals' leading position in the development of long-acting antidiabetic therapies. Building on these positive outcomes, the company will continue to advance the research and development of innovative treatments for diabetes. Currently, Gan & Lee has initiated and is accelerating large-scale Phase 3 clinical programs in China for bofanglutide injection and GZR4 injections for the treatment of type 2 diabetes, aiming to provide more effective treatment options for patients with diabetes. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. SOURCE Gan & Lee Pharmaceuticals
Medscape
20-06-2025
- Health
- Medscape
Cancer Concerns Spark Caution Over Weight Loss Injections
Cancer patients should seek medical advice before using weight loss injections, a leading UK charity has said. Macmillan Cancer Support urged patients not to view these drugs as 'quick fixes', following a rise in helpline queries over whether they should take them. Obesity is a well-established risk factor for several cancer types and is linked to worse outcomes in patients who already have a cancer diagnosis. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have seen rapid uptake for weight loss. Their popularity has helped fuel speculation that they could reduce the risk of cancer or improve outcomes in people with obesity-related cancers. Mixed Findings on Cancer Risk and Benefits A study published in The Lancet eClinical Medicine in May compared outcomes in patients treated with GLP-1 RAs versus bariatric surgery. The research involved 3178 age- and BMI-matched pairs in Israel. Despite surgery achieving greater weight loss, both groups had similar rates of obesity-related cancers. The researchers suggested that there could be additional pathways beyond weight loss through which GLP-1RAs might lower cancer risk, for example by reducing inflammation. Other experts have proposed additional pathways, including enhanced immune responses, improved insulin sensitivity, hormonal modulation, and changes to gut microbiome. As a result of the study, clinical trials of GLP-1RAs as potential anti-cancer agents are planned. Potential Risks: Thyroid and Pancreatic Cancer Some studies have suggested that GLP-1RAs carry a minor increase in the risk of thyroid cancer, which is one of the 13 cancers known to be linked with obesity. Some GLP-1RAs now carry warnings about this potential link, although the evidence is conflicting. One meta-analysis of 64 studies by Italian researchers, published in March 2024, found a significant increase overall thyroid cancer risk. However, the data did not show a significant rise in papillary or medullary thyroid cancer when analysed separately. The researchers concluded that GLP-1RA treatment could be associated with a moderate increase in the relative risk of thyroid cancer, though the absolute risk remained small. They called for longer-term studies to clarify the link. In contrast, a Scandinavian cohort study published in April found no substantial increase in thyroid cancer risk over an average follow-up of 3.9 years. The authors said the findings did not rule out a slight increase but suggested no more than a 31% relative risk rise. Similar concerns have been raised about a theoretical risk of pancreatic cancer, but no conclusive evidence has been found. Macmillan Helpline Sees Spike in Inquiries Following recent media coverage, Macmillan Cancer Support reported a surge in calls and messages about weight loss medications, including the potential risk to people with thyroid cancer. Dr Owen Carter, Macmillan's national clinical adviser, said in a press release that there had been "a noticeable increase" in calls to the charity's free support line, alongside "a flurry of messages" on its peer-to-peer online community platform. In response, the charity has published updated information about weight loss injections and cancer on its website. Carter said that some callers were concerned about taking weight loss drugs while undergoing cancer treatments such as chemotherapy or hormone therapy. While there is currently not enough evidence, "we do know that these drugs may affect how other drugs are absorbed by your body," he said. "This may include some anti-cancer drugs." Weight Loss Before Surgery and Pre-habilitation Other patients have asked whether weight loss medication is safe to take before surgery for cancer. "Understandably, people are keen to do what they can to get ready for cancer treatment," Carter said. Healthcare professionals often recommend pre-habilitation to help patients prepare for treatment by improving their fitness and overall health. However, Carter warned against unprescribed use of weight loss injections as 'quick fixes'. 'We simply do not know enough about the long-term impact of these weight loss medications to recommend them if they're not prescribed by a specialist,' he said. Carter also emphasised the importance of making lifestyle changes alongside use of medications. "We know that eating well and staying as active as possible are proven to help people feel better, increase their energy levels, and strengthen their immune systems, which can help them to manage their weight and cope better with cancer treatment", he said. Risks of Unregulated Online Purchases Macmillan also raised concerns about people buying GLP-1 RAs online from unregulated sources. Some patients are reported to have experienced severe side effects from counterfeit medicines. The charity urged people to speak to their GP before taking weight loss drugs. Macmillan noted that potential side-effects of GLP-1RAs include nausea and vomiting, abdominal pain, diarrhoea or constipation, and fatigue. They can also reduce the effectiveness of oral contraceptives. There have been reports of unplanned pregnancies occurring while taking these drugs, which may be particularly hazardous in cancer patients, as some cancer treatments are teratogenic.
Yahoo
18-06-2025
- Health
- Yahoo
Weight loss jabs may achieve less drastic results outside trials, study suggests
People using weight loss jabs shed far fewer pounds in the real world than in clinical trials, researchers have found. Jabs such as Wegovy and Mounjaro, which contain the drugs semaglutide and tirzepatide respectively, have transformed the treatment of obesity, with studies suggesting the former can help people lose up to 20% of their body weight after 72 weeks of treatment. However, a new study suggests the drugs, known as GLP-1 RAs, may not produce such drastic weight loss in everyday settings. 'The average patient on [GLP-1 RAs] in the real world is not getting the weight loss that we see in clinical trials,' said the study's senior author, Dr Karan Chhabra, from the Grossman school of medicine at New York University. Researchers analysed data from 51,085 patients with a body mass index of 35 or greater and who were eligible for weight loss surgery and weight loss jabs. The team compared the weight loss in 38,545 people prescribed semaglutide or tirzepatide by their doctor with that in 12,540 patients who underwent weight loss surgery, over a period of up to three years. After taking into account factors such as age, body mass index and health problems of participants, the team found patients who underwent bariatric surgery had significantly greater average weight loss at all measured time points than those who received prescriptions for semaglutide or tirzepatide. For example, after two years, people who underwent bariatric surgery had on average a 26.5% reduction in their body weight, compared with 5.7% for those prescribed GLP-1 RAs for any duration. The study has not yet been peer reviewed and is due to be presented at the American Society for Metabolic and Bariatric Surgery 2025 annual scientific meeting. Chhabra said: 'The most reliable way to lose 20% to 30% of your weight is to get a bariatric operation.' He said it was not clear why the weight loss jabs had a smaller effect in the real world than in trials, but he noted that their cost and others barriers to access could mean people were unable to continue their use over the long term, while doctors' efforts could also play a role, given how it is important that dosage is increased over time, side-effects are monitored and additional support is offered. Chhabra said further work was needed to ensure patients who want to take such medications get the greatest effectiveness. 'Our goal is to get as many people to the right treatment [for obesity] as possible. But they need to know what to expect from the treatment that they're choosing, and that needs to be guided by real-world data, not clinical trial data,' he said. Prof Naveed Sattar, of the University of Glasgow, who was not involved in the work, pointed to recent follow-up studies of trials involving tirzepatide showing substantial weight loss over three years. But he said in real life many patients stop medicines early either because of their cost or poorly handled side-effects. 'That said, bariatric surgery done well can do well for many people and is certainly cheaper over the longer run,' he said. 'The issue may be that most people likely prefer to take medicines for weight loss rather than have surgery, at least in the first instance, now that the medicines can approach weight loss levels seen with surgery.'
The Guardian
17-06-2025
- Health
- The Guardian
Weight loss jabs may achieve less drastic results outside trials, study suggests
People using weight loss jabs shed far fewer pounds in the real world than in clinical trials, researchers have found. Jabs such as Wegovy and Mounjaro, which contain the drugs semaglutide and tirzepatide respectively, have transformed the treatment of obesity, with studies suggesting the former can help people lose up to 20% of their body weight after 72 weeks of treatment. However, a new study suggests the drugs, known as GLP-1 RAs, may not produce such drastic weight loss in everyday settings. 'The average patient on [GLP-1 RAs] in the real world is not getting the weight loss that we see in clinical trials,' said the study's senior author, Dr Karan Chhabra, from the Grossman school of medicine at New York University. Researchers analysed data from 51,085 patients with a body mass index of 35 or greater and who were eligible for weight loss surgery and weight loss jabs. The team compared the weight loss in 38,545 people prescribed semaglutide or tirzepatide by their doctor with that in 12,540 patients who underwent weight loss surgery, over a period of up to three years. After taking into account factors such as age, body mass index and health problems of participants, the team found patients who underwent bariatric surgery had significantly greater average weight loss at all measured time points than those who received prescriptions for semaglutide or tirzepatide. For example, after two years, people who underwent bariatric surgery had on average a 26.5% reduction in their body weight, compared with 5.7% for those prescribed GLP-1 RAs for any duration. The study has not yet been peer reviewed and is due to be presented at the American Society for Metabolic and Bariatric Surgery 2025 annual scientific meeting. Chhabra said: 'The most reliable way to lose 20% to 30% of your weight is to get a bariatric operation.' He said it was not clear why the weight loss jabs had a smaller effect in the real world than in trials, but he noted that their cost and others barriers to access could mean people were unable to continue their use over the long term, while doctors' efforts could also play a role, given how it is important that dosage is increased over time, side-effects are monitored and additional support is offered. Chhabra said further work was needed to ensure patients who want to take such medications get the greatest effectiveness. 'Our goal is to get as many people to the right treatment [for obesity] as possible. But they need to know what to expect from the treatment that they're choosing, and that needs to be guided by real-world data, not clinical trial data,' he said. Prof Naveed Sattar, of the University of Glasgow, who was not involved in the work, pointed to recent follow-up studies of trials involving tirzepatide showing substantial weight loss over three years. But he said in real life many patients stop medicines early either because of their cost or poorly handled side-effects. 'That said, bariatric surgery done well can do well for many people and is certainly cheaper over the longer run,' he said. 'The issue may be that most people likely prefer to take medicines for weight loss rather than have surgery, at least in the first instance, now that the medicines can approach weight loss levels seen with surgery.'
