Latest news with #Plainsboro
Associated Press
11 hours ago
- Business
- Associated Press
West Windsor-Plainsboro Regional School District Enhances Educators' Ability To Interpret Student Data and Improve Achievement Through New Partnership
CHARLOTTE, N.C., June 27, 2025 /3BL/ - In a first of its kind agreement, New Jersey's West Windsor-Plainsboro Regional School District (WWP) today announced a new partnership with Otus, the leading K-12 assessment, data, and insights solution, and Discovery Education, the creators of essential PreK-12 learning solutions used in classrooms around the world. Through this collaboration, Otus and Discovery Education are providing new resources that help WWP organize student data into actionable insights and enhance district educators' ability to interpret that data and make informed, strategic decisions that improve achievement. Located in Central New Jersey's Mercer County, WWP is a PreK-12 public school district that educates over 9,300 students and employs over 1,300 staff members in 10 schools across the West Windsor and Plainsboro Townships. Building upon their tradition of excellence, WWP's mission is to empower all learners to thoughtfully contribute to a diverse and changing world with confidence, strength of character, and love of learning. To enhance the district's ability to collect, read, and react to student assessment data, WWP's team sought a digital solution that offered unparalleled insight into student performance. In addition, school administrators sought one resource that would provide both educators and families the tools and insights needed to support student success. Following a careful review of available solutions, WWP selected the Otus platform provided through Discovery Education. Through the Otus platform, WWP educators will: DreamBox Math by Discovery Educationhost of improvementsindependently proven According to Allan Johnson, WWP's Supervisor of Technology, Training, & Media Sources, 'The addition of Otus to the district tech stack improves our educators' ability to easily pull and analyze achievement data and then adjust instruction to improve student outcomes. We look forward to deploying this new resource districtwide.' WWP educators using Otus will receive dedicated professional development from Otus' team of professional learning experts. Through these interactive professional development sessions, participants will learn best practices for integrating their new digital resources into instruction. Effective professional learning increases student engagement and supports the continued academic development of all students. 'Discovery Education is thrilled to continue to support the students and teachers of the West Windsor-Plainsboro Regional School District through its unique collaboration with Otus,' said Tori Byrd, Discovery Education's Manager of Educational Partnerships. 'As the first school system nationwide to leverage the unique partnership between Otus and Discovery Education to combine high-quality learning solutions and state-of-the-art data analytics, West Windsor-Plainsboro is setting a new bar for innovation in this space.' To learn about how Otus and Discovery Education have collaborated to support student achievement, visit For more information about Otus, visit and stay connected to Otus on social media through X, LinkedIn, Instagram, and Facebook. For more information about Discovery Education, visit and stay connected with Discovery Education on social media through LinkedIn, Instagram, TikTok, and Facebook. ### About Otus Otus, an award-winning edtech platform, empowers educators to maximize student performance with comprehensive solutions for K12 assessment, data, and insights. Committed to student achievement and educational equity, Otus combines student data with powerful tools that provide educators, administrators, and families with the insights they need to make a difference. Built by teachers for teachers, Otus creates efficiencies in data management, assessments, and progress monitoring to help educators focus on what matters most—student success. Today, Otus partners with school districts nationwide to create informed, data-driven learning environments. Learn more at About Discovery Education Discovery Education is the worldwide edtech leader whose state-of-the-art, PreK-12, digital solutions support learning wherever it takes place. Through award-winning multimedia content, instructional supports, innovative classroom tools, and strategic alliances, Discovery Education helps educators deliver powerful learning experiences that engage all students and support higher academic achievement on a global scale. Discovery Education serves approximately 4.5 million educators and 45 million students worldwide, and its resources are accessed in over 100 countries and territories. Through partnerships with districts, states, and trusted organizations, Discovery Education empowers teachers with essential edtech solutions that inspire curiosity, build confidence, and accelerate learning. Explore the future of education at Contact Mike Peterson Otus Phone: 651-307-9251 Email: [email protected] Stephen Wakefield Discovery Education Phone: 202-316-6615 Email: [email protected] Visit 3BL Media to see more multimedia and stories from Discovery Education
Yahoo
5 days ago
- Business
- Yahoo
Novo Nordisk terminates collaboration with Hims & Hers Health, Inc. due to concerns about their illegal mass compounding and deceptive marketing
Collaboration of over one month has ended based on Hims & Hers deceptive promotion and selling of illegitimate, knockoff versions of Wegovy® that put patient safety at risk Novo Nordisk won't stop taking action to protect Americans from the dangers of illicit foreign active pharmaceutical ingredients in knock-off drugs Efforts will continue to make authentic, FDA-approved Wegovy® directly available through NovoCare® Pharmacy to select telehealth organizations that share our commitment to safe and effective medical treatment for patients living with chronic diseases PLAINSBORO, N.J., June 23, 2025 /PRNewswire/ -- Novo Nordisk announced today that the company will no longer be working with Hims & Hers Health, Inc., and that direct access to Wegovy® will no longer be available to Hims & Hers Health, Inc. via NovoCare® Pharmacy. In late April, the FDA resolved the Wegovy® shortage based on its conclusion that Novo Nordisk is fully meeting current and projected nationwide demand for this medicine. In support of transitioning patients from knock-off compounded versions to authentic, FDA-approved Wegovy® through NovoCare® Pharmacy, Novo Nordisk began collaborating with telehealth companies. Over one month into the collaboration, Hims & Hers Health, Inc. has failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of "personalization" and are disseminating deceptive marketing that put patient safety at risk. "Novo Nordisk is firm on our position and protecting patients living with obesity. When patients are prescribed semaglutide treatments by their licensed healthcare professional or a telehealth provider, they are entitled to receive authentic, FDA-approved and regulated Wegovy®," said Dave Moore, Executive Vice President, US Operations of Novo Nordisk Inc. "We will work with telehealth companies to provide direct access to Wegovy® that share our commitment to patient safety – and when companies engage in illegal sham compounding that jeopardizes the health of Americans, we will continue to take action." Novo Nordisk is deeply concerned and is continuing to take proactive measures to keep US patients safe from knock-off drugs made with foreign illicit active pharmaceutical ingredients. Based on Novo Nordisk's investigation, the "semaglutide" active pharmaceutical ingredients that are in the knock-off drugs sold by telehealth entities and compounding pharmacies are manufactured by foreign suppliers in China. According to a report from the Brookings Institute, FDA has never authorized or approved the manufacturing processes used by any of these foreign suppliers to make semaglutide, nor has FDA ever reviewed or authorized the quality of the "semaglutide" they produce. The report also found that a "large share of [these Chinese suppliers] were never inspected by FDA, and many of those that were [inspected] had drug quality assurance violations." US patients should not be exposed to knock-off drugs made with unsafe and illicit foreign ingredients. More information can be found on About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.1-3 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.2,3 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.4,5 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.6,7 In the US, about 40% of adults live with obesity.8 About NovoCare® Pharmacy NovoCare® Pharmacy provides cash-paying patients who have been prescribed Wegovy® with the ability to schedule shipments of their Wegovy® prescriptions directly to their home. Beyond convenient home delivery, NovoCare® also supports patients with benefit verification, refill reminders, and access to live support from a NovoCare® case manager. More information about NovoCare® Pharmacy is available at NovoCare® pharmacy | NovoCare®. About Wegovy® (semaglutide) injection 2.4 mg What is Wegovy®? WEGOVY® (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity: to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight. that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off. Wegovy® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines. It is not known if Wegovy® is safe and effective for use in children under 12 years of age. Important Safety Information What is the most important information I should know about Wegovy®? Wegovy® may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use Wegovy® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use Wegovy® if: you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy® Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you: have or have had problems with your pancreas or kidneys have type 2 diabetes and a history of diabetic retinopathy have or have had depression, suicidal thoughts, or mental health issues are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. It is not known if Wegovy® passes into your breast milk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. What are the possible side effects of Wegovy®? Wegovy® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy®. Tell your healthcare provider if you have stomach problems that are severe or will not go away. serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy® increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy® before you are scheduled to have surgery or other procedures The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat. Please see Medication Guide and Prescribing Information, including Boxed Warning, for Wegovy® at 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: 1. 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. 2. 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. 3. 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. 4. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: 5. World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: 6. Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: 7. Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: 8. 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: View original content to download multimedia: SOURCE NOVO NORDISK INC. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
7 days ago
- Health
- Associated Press
Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The Lancet
PLAINSBORO, N.J., June 20, 2025 /PRNewswire/ -- Today, results from two early-phase clinical trials evaluating Novo Nordisk's amycretin, an innovative investigational obesity treatment designed to target appetite regulation, were published in The Lancet.1 In a phase 1b/2a clinical trial of 125 adults with overweight or obesity, once-weekly subcutaneous amycretin appeared to be safe and tolerable in trial participants, who also achieved significantly greater weight loss across the full range of doses investigated versus placebo.1 A related phase 1 trial of once-daily oral amycretin in adults with obesity or overweight also showed that treatment was safe and tolerable with an observed reduction in body weight compared to placebo.2 No weight loss plateau was observed in either trial at the end of the respective treatment durations.1,2 Data on subcutaneous amycretin is scheduled to be presented on Sunday, June 22nd, during a late-breaking poster session at the American Diabetes Association's® (ADA) 85th Scientific Sessions.1 'We are pleased with the promising results of amycretin and the feedback from regulatory authorities and are excited to advance both subcutaneous and oral versions of this molecule into phase 3 development for weight management. At Novo Nordisk, we understand that addressing obesity is a complex challenge that many patients face. These results reflect our robust pipeline in obesity, our focus on progressing scientific innovation and expanding the range of options available to patients and healthcare professionals,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'We remain steadfast in our mission to discover and develop therapies that can have a meaningful impact in the lives of those affected by obesity.' Results from the phase 1b/2a trial of subcutaneous amycretin showed treatment-emergent adverse events (TEAEs) were mild or moderate in severity and increased in frequency in a dose-dependent manner. The most frequent reported TEAEs were gastrointestinal in nature. Compared to placebo, participants receiving amycretin observed greater weight loss across the full range of doses investigated.1 Subcutaneous amycretin at multiple doses demonstrated greater weight reduction than placebo at the end of the trial. Participants who received the highest doses (up to 60 mg) reported body weight reductions of up to 24.3% versus 1.1% with placebo after 36 weeks of treatment. Results from this first-in-human phase 1b/2a study support further investigation of potential weight-loss efficacy of amycretin. Results from the published phase 1 trial of oral amycretin showed that the most common TEAEs were related to gastrointestinal symptoms (mainly nausea and vomiting) and decreased appetite; these were most frequent for the higher doses. Trial participants receiving the study treatment demonstrated significantly greater weight loss across the full range of doses investigated versus the placebo group.2 Exploratory results showed participants taking 100 mg per day of oral amycretin achieved a mean weight loss of 13.1% versus 1.2% with placebo after 12 weeks.2 Based on these phase 1 results, longer evaluation with more participants is warranted to substantiate the full efficacy findings of oral amycretin on body weight reductions and changes in metabolic parameters. Novo Nordisk will advance both subcutaneous and oral amycretin formulations straight to phase 3 development for weight management based on these and other completed clinical studies, as well as feedback received from regulatory authorities. About amycretin Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide a treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is under investigation for oral and subcutaneous administration, and is not approved in the US for weight loss. About the phase 1b/2a subcutaneous amycretin trial The phase 1b/2a trial was a randomized, placebo-controlled, single-center, double-blinded study of 125 participants assessing the safety, tolerability, pharmacokinetics, and effects on body weight after subcutaneous administration of amycretin in people with overweight or obesity.1 Adults with a body mass index of 27-39.9kg/m2 and glycated hemoglobin (HbA1c) <6.5% were eligible for the trial.1 The trial was conducted in 5 parts: a single ascending dose (Part A) for determination of pharmacokinetics and starting dose for the first multiple dose cohort in which the safety and tolerability were explored using dose escalation until 36 weeks of total treatment duration (Part B).1 Lastly, in the multiple ascending dose – dose response parts, body weight loss was explored for up to 36 weeks of dosing by escalating to dose levels of 1.25 mg, 5 mg, and 20 mg, respectively, dosed for 12 weeks (Part E, D and C).1 About the phase 1 oral amycretin trial The phase 1 single-center, randomized, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (Part A) and multiple ascending doses (Part B, 10 days of treatment; Part C/D, 12 weeks of treatment) of 144 adult participants with overweight or obesity.2 The primary endpoint was the number of treatment-emergent adverse events (TEAEs) observed in the trial. The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.2 About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.3-5 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.3,5 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.6,7 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.8,9 In the US, about 40% of adults live with obesity.10 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 References © 2025 Novo Nordisk All rights reserved. US25SEMO01477 June 2025 View original content to download multimedia: SOURCE NOVO NORDISK INC.
Yahoo
20-06-2025
- Health
- Yahoo
Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The Lancet
Both subcutaneous and oral formulations will advance straight to phase 3 development based on completed clinical studies and feedback received from regulatory authorities1,2 PLAINSBORO, N.J., June 20, 2025 /PRNewswire/ -- Today, results from two early-phase clinical trials evaluating Novo Nordisk's amycretin, an innovative investigational obesity treatment designed to target appetite regulation, were published in The Lancet.1 In a phase 1b/2a clinical trial of 125 adults with overweight or obesity, once-weekly subcutaneous amycretin appeared to be safe and tolerable in trial participants, who also achieved significantly greater weight loss across the full range of doses investigated versus placebo.1 A related phase 1 trial of once-daily oral amycretin in adults with obesity or overweight also showed that treatment was safe and tolerable with an observed reduction in body weight compared to placebo.2 No weight loss plateau was observed in either trial at the end of the respective treatment durations.1,2 Data on subcutaneous amycretin is scheduled to be presented on Sunday, June 22nd, during a late-breaking poster session at the American Diabetes Association's® (ADA) 85th Scientific Sessions.1 "We are pleased with the promising results of amycretin and the feedback from regulatory authorities and are excited to advance both subcutaneous and oral versions of this molecule into phase 3 development for weight management. At Novo Nordisk, we understand that addressing obesity is a complex challenge that many patients face. These results reflect our robust pipeline in obesity, our focus on progressing scientific innovation and expanding the range of options available to patients and healthcare professionals," said Martin Holst Lange, executive vice president for Development at Novo Nordisk. "We remain steadfast in our mission to discover and develop therapies that can have a meaningful impact in the lives of those affected by obesity." Results from the phase 1b/2a trial of subcutaneous amycretin showed treatment-emergent adverse events (TEAEs) were mild or moderate in severity and increased in frequency in a dose-dependent manner. The most frequent reported TEAEs were gastrointestinal in nature. Compared to placebo, participants receiving amycretin observed greater weight loss across the full range of doses investigated.1 Subcutaneous amycretin at multiple doses demonstrated greater weight reduction than placebo at the end of the trial. Participants who received the highest doses (up to 60 mg) reported body weight reductions of up to 24.3% versus 1.1% with placebo after 36 weeks of treatment. Results from this first-in-human phase 1b/2a study support further investigation of potential weight-loss efficacy of amycretin. Results from the published phase 1 trial of oral amycretin showed that the most common TEAEs were related to gastrointestinal symptoms (mainly nausea and vomiting) and decreased appetite; these were most frequent for the higher doses. Trial participants receiving the study treatment demonstrated significantly greater weight loss across the full range of doses investigated versus the placebo group.2 Exploratory results showed participants taking 100 mg per day of oral amycretin achieved a mean weight loss of 13.1% versus 1.2% with placebo after 12 weeks.2 Based on these phase 1 results, longer evaluation with more participants is warranted to substantiate the full efficacy findings of oral amycretin on body weight reductions and changes in metabolic parameters. Novo Nordisk will advance both subcutaneous and oral amycretin formulations straight to phase 3 development for weight management based on these and other completed clinical studies, as well as feedback received from regulatory authorities. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide a treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is under investigation for oral and subcutaneous administration, and is not approved in the US for weight loss. About the phase 1b/2a subcutaneous amycretin trialThe phase 1b/2a trial was a randomized, placebo-controlled, single-center, double-blinded study of 125 participants assessing the safety, tolerability, pharmacokinetics, and effects on body weight after subcutaneous administration of amycretin in people with overweight or obesity.1 Adults with a body mass index of 27-39.9kg/m2 and glycated hemoglobin (HbA1c) <6.5% were eligible for the trial.1 The trial was conducted in 5 parts: a single ascending dose (Part A) for determination of pharmacokinetics and starting dose for the first multiple dose cohort in which the safety and tolerability were explored using dose escalation until 36 weeks of total treatment duration (Part B).1 Lastly, in the multiple ascending dose – dose response parts, body weight loss was explored for up to 36 weeks of dosing by escalating to dose levels of 1.25 mg, 5 mg, and 20 mg, respectively, dosed for 12 weeks (Part E, D and C).1 About the phase 1 oral amycretin trial The phase 1 single-center, randomized, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (Part A) and multiple ascending doses (Part B, 10 days of treatment; Part C/D, 12 weeks of treatment) of 144 adult participants with overweight or obesity.2 The primary endpoint was the number of treatment-emergent adverse events (TEAEs) observed in the trial. The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.2 About obesityObesity is a serious chronic, progressive, and complex disease that requires long-term management.3-5 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.3,5 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.6,7 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.8,9 In the US, about 40% of adults live with obesity.10 About Novo NordiskNovo 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 Dahl K, Toubro S, Dey S, et al. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: Results of a randomised, controlled, phase 1b/2a study. The Lancet. Published online: June 20, 2025. Gasiorek A, Heydorn A, Gabery S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, randomised, placebo-controlled study. The Lancet. Published online: June 20, 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: 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: © 2025 Novo Nordisk All rights reserved. US25SEMO01477 June 2025 View original content to download multimedia: SOURCE NOVO NORDISK INC.
