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Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA

Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA

Business Upturn5 hours ago

By GlobeNewswire Published on June 21, 2025, 04:38 IST
Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA Results from the phase 3b STEP UP trial showed that a higher dose of Wegovy ® (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo 1
(semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo Safety and tolerability of the higher dose of Wegovy ® (semaglutide 7.2 mg) was consistent with the currently approved dose (semaglutide 2.4 mg) 1
(semaglutide 7.2 mg) was consistent with the currently approved dose (semaglutide 2.4 mg) The STEP UP data add to the existing evidence base on the value of Wegovy® in delivering significant weight loss and health gains for people living with obesity
Bagsværd, Denmark, 21 June 2025 – Novo Nordisk today presented the results from the phase 3b STEP UP trial in people with obesity without diabetes at the American Diabetes Association (ADA) Scientific Sessions, in Chicago, US. In the STEP UP trial, the higher dose of Wegovy® (semaglutide 7.2 mg) demonstrated a mean weight loss of 21%, with a third of participants losing 25% or more of their body weight compared to placebo at 72 weeks.1
'The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide's established safety profile. This may offer another option to people who do not attain their weight goals,' said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada. 'We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes. These findings help to give patients with obesity more options for improvements in their weight and overall health.'
STEP UP co-primary endpoints at 72 weeks *1 :
semaglutide 7.2 mg semaglutide 2.4 mg PlaceboWeight loss 20.7% 17.5% 2.4%
5% or more weight loss 93.2% 92.5% 35.7%
When evaluating the effect of treatment regardless of treatment adherence, people receiving semaglutide 7.2 mg achieved 18.7% weight loss vs 3.9% with placebo, and 90.7% achieved 5% or more weight loss with semaglutide 7.2 mg vs 36.8% on placebo.
'With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'As pioneers in obesity, we continue to develop new innovative treatments to fit the needs and preferences of people living with obesity. This includes maximising the value of semaglutide for individuals, healthcare systems and society, and developing a new oral formulation of Wegovy® that, pending FDA approval, can become the first GLP-1 pill to offer double-digit weight loss.'
In the STEP UP trial, semaglutide 7.2 mg demonstrated a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.1 The most common adverse events were gastrointestinal, and the vast majority were mild to moderate during dose escalation and diminished over time, consistent with the GLP-1 class.1 In STEP UP, 3.3% of people treated with semaglutide 7.2 mg discontinued due to gastrointestinal adverse events, compared to 2.0% with semaglutide 2.4 mg and 0% with placebo.1
Novo Nordisk expects to file the higher dose of Wegovy® for a label update in the EU in the second half of 2025, followed by regulatory submissions in other markets where Wegovy® is already approved.
STEP UP selected confirmatory secondary endpoints at 72 weeks * 1 :
semaglutide 7.2 mg semaglutide 2.4 mg Placebo10% or more weight loss 86.0% 77.6% 20.0%15% or more weight loss 70.4% 57.5% 7.9%20% or more weight loss 50.9% 35.1% 2.9%
25% or more weight loss 33.2% 16.7% 0%
* Based on the trial product estimand: treatment effect if all people adhered to treatment.
About the STEP UP trials
Novo Nordisk has completed two trials, STEP UP and STEP UP T2D, investigating the efficacy and safety of semaglutide 7.2 mg in people with obesity with or without type 2 diabetes.
The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy and safety of semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included 1,407 adults with a BMI ≥30 kg/m2 without diabetes. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key confirmatory secondary endpoints included the number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively.
The 72-week STEP UP T2D trial investigated semaglutide 7.2 mg in 512 adults with obesity and type 2 diabetes, with the primary objective to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss.
About Wegovy®
Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in HFpEF-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis.
In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition.
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 novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube .
Contacts for further information
References Wharton, S, et al. (2025). Once-weekly semaglutide 7.2 mg in adults with obesity: the randomised, controlled, phase 3b STEP UP trial. 1966-LB poster. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025.17.
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Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
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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
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

Associated Press

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  • 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.

Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA
Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA

Business Upturn

time5 hours ago

  • Business Upturn

Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA

By GlobeNewswire Published on June 21, 2025, 04:38 IST Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA Results from the phase 3b STEP UP trial showed that a higher dose of Wegovy ® (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo 1 (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo Safety and tolerability of the higher dose of Wegovy ® (semaglutide 7.2 mg) was consistent with the currently approved dose (semaglutide 2.4 mg) 1 (semaglutide 7.2 mg) was consistent with the currently approved dose (semaglutide 2.4 mg) The STEP UP data add to the existing evidence base on the value of Wegovy® in delivering significant weight loss and health gains for people living with obesity Bagsværd, Denmark, 21 June 2025 – Novo Nordisk today presented the results from the phase 3b STEP UP trial in people with obesity without diabetes at the American Diabetes Association (ADA) Scientific Sessions, in Chicago, US. In the STEP UP trial, the higher dose of Wegovy® (semaglutide 7.2 mg) demonstrated a mean weight loss of 21%, with a third of participants losing 25% or more of their body weight compared to placebo at 72 weeks.1 'The STEP UP trial demonstrated that we can increase the dose of semaglutide and achieve greater weight loss than previously seen, and in line with semaglutide's established safety profile. This may offer another option to people who do not attain their weight goals,' said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, Canada. 'We are already aware that semaglutide can have health benefits for people with heart disease, liver disease, knee osteoarthritis, type 2 diabetes and prediabetes. These findings help to give patients with obesity more options for improvements in their weight and overall health.' STEP UP co-primary endpoints at 72 weeks *1 : semaglutide 7.2 mg semaglutide 2.4 mg PlaceboWeight loss 20.7% 17.5% 2.4% 5% or more weight loss 93.2% 92.5% 35.7% When evaluating the effect of treatment regardless of treatment adherence, people receiving semaglutide 7.2 mg achieved 18.7% weight loss vs 3.9% with placebo, and 90.7% achieved 5% or more weight loss with semaglutide 7.2 mg vs 36.8% on placebo. 'With these results, semaglutide reaffirms its significant weight loss for people with obesity. The STEP UP trial delivers a substantial weight loss of over 20%, in addition to health benefits previously demonstrated with semaglutide,' said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. 'As pioneers in obesity, we continue to develop new innovative treatments to fit the needs and preferences of people living with obesity. This includes maximising the value of semaglutide for individuals, healthcare systems and society, and developing a new oral formulation of Wegovy® that, pending FDA approval, can become the first GLP-1 pill to offer double-digit weight loss.' In the STEP UP trial, semaglutide 7.2 mg demonstrated a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.1 The most common adverse events were gastrointestinal, and the vast majority were mild to moderate during dose escalation and diminished over time, consistent with the GLP-1 class.1 In STEP UP, 3.3% of people treated with semaglutide 7.2 mg discontinued due to gastrointestinal adverse events, compared to 2.0% with semaglutide 2.4 mg and 0% with placebo.1 Novo Nordisk expects to file the higher dose of Wegovy® for a label update in the EU in the second half of 2025, followed by regulatory submissions in other markets where Wegovy® is already approved. STEP UP selected confirmatory secondary endpoints at 72 weeks * 1 : semaglutide 7.2 mg semaglutide 2.4 mg Placebo10% or more weight loss 86.0% 77.6% 20.0%15% or more weight loss 70.4% 57.5% 7.9%20% or more weight loss 50.9% 35.1% 2.9% 25% or more weight loss 33.2% 16.7% 0% * Based on the trial product estimand: treatment effect if all people adhered to treatment. About the STEP UP trials Novo Nordisk has completed two trials, STEP UP and STEP UP T2D, investigating the efficacy and safety of semaglutide 7.2 mg in people with obesity with or without type 2 diabetes. The 72-week STEP UP trial was a randomised, double-blinded, parallel-group, placebo-controlled, superiority trial designed to evaluate the efficacy and safety of semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included 1,407 adults with a BMI ≥30 kg/m2 without diabetes. The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. Key confirmatory secondary endpoints included the number of participants achieving 10%, 15%, 20% and 25% weight loss, respectively. The 72-week STEP UP T2D trial investigated semaglutide 7.2 mg in 512 adults with obesity and type 2 diabetes, with the primary objective to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss. About Wegovy® Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in HFpEF-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis. In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition. 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 Wharton, S, et al. (2025). Once-weekly semaglutide 7.2 mg in adults with obesity: the randomised, controlled, phase 3b STEP UP trial. 1966-LB poster. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025.17. 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.

Novo Nordisk's subcutaneous and oral amycretin data published in The Lancet and presented at ADA 2025
Novo Nordisk's subcutaneous and oral amycretin data published in The Lancet and presented at ADA 2025

Business Upturn

time5 hours ago

  • Business Upturn

Novo Nordisk's subcutaneous and oral amycretin data published in The Lancet and presented at ADA 2025

By GlobeNewswire Published on June 21, 2025, 04:34 IST Subcutaneous amycretin phase 1b/2a data on the safety, tolerability and weight loss potential in people with overweight or obesity was published in The Lancet and presented at the American Diabetes Association (ADA) Scientific Sessions. 1,2 and presented at the American Diabetes Association (ADA) Scientific Sessions. Oral amycretin phase 1 data on the safety, tolerability and weight loss potential in people with overweight or obesity was also published in The Lancet. 3 Findings from the clinical trials indicate amycretin appeared tolerable with a safety profile consistent with other GLP-1 and amylin receptor agonists.1,2,3 Bagsværd, Denmark, 20 June 2025 – Novo Nordisk announces subcutaneous amycretin data being presented at the American Diabetes Association (ADA) 85 th Scientific Sessions in Chicago, US.1 Full results of two clinical trials evaluating the safety, tolerability and weight loss potential of subcutaneous and oral amycretin in people with overweight or obesity were published today in The Lancet medical journal.1,3 Amycretin is the first treatment that combines GLP-1 and amylin receptor agonism biology in a single molecule. The published and presented results from the once-weekly subcutaneous amycretin phase 1b/2a clinical trial showed that participants who received the treatment demonstrated significantly greater weight loss across the full range of doses investigated compared to placebo. Data being presented at ADA were collected from two parts of the trial; dose escalation (amycretin 60 mg), and dose escalation and maintenance (amycretin 20 mg, 5 mg and 1.25 mg).1,2 No plateauing in weight reduction was observed at the end of treatment (ranging from 20 to 36 weeks) with all tested doses, suggesting that a longer treatment duration may potentially contribute to additional weight loss.1,2 Estimated mean change in body weight from baseline with once-weekly subcutaneous (SC) amycretin: 1,2 * Dose Treatment % Weight change % Weight change duration (SC amycretin) (placebo) 60 mg 36 weeks -24.3% -1.1%20 mg** 36 weeks -22.0% 1.9%5 mg** 28 weeks -16.2% 2.3% 1.25 mg** 20 weeks -9.7% 2.0% * If all people adhered to treatment i.e. if all people followed the planned dosing schedule for the full trial period without any treatment discontinuations. ** Administered during a 12-week maintenance period. Once-weekly subcutaneous amycretin treatment escalated up to 60 mg appeared tolerable with a safety profile consistent with other GLP-1 and amylin receptor agonists.1,2 The number of treatment-emergent adverse events (TEAEs) increased in a dose-dependent manner, were mostly gastrointestinal, and were comparable to the rate and profile of TEAEs reported in early-phase studies of GLP-1 receptor, GLP-1 receptor/gastric inhibitory polypeptide (GIP) receptor, and amylin receptor agonists.1,2 The majority of TEAEs were mild to moderate in severity and resolved by the end of the study period.1,2 Of the participants who discontinued the trial, the majority were due to non-TEAE reasons.1,2 'As pioneers in obesity innovation, we are exploring multiple biological pathways to develop potentially transformative medicines that support the individual needs and preferences of people with obesity on their weight loss journey towards overall improved health,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk . 'Amycretin is the first investigational treatment that combines GLP-1 and amylin receptor agonism biology in one molecule, working on distinct pathways and offering complementary effects on appetite control. The findings published and presented today are encouraging. We are excited to advance the clinical development of subcutaneous and oral amycretin into phase 3 to assess its potential as a therapeutic option for weight management.' The published once-daily oral amycretin phase 1 clinical trial data showed that participants receiving amycretin achieved greater weight loss compared to placebo.3 After 12 weeks of treatment with amycretin up to 50 mg and up to 2 times 50 mg, participants achieved a mean change in body weight of -10.4% and -13.1% respectively, compared to -1.2% with placebo.3 There were no apparent signs of weight loss plateauing within the 12 weeks of treatment in either of these amycretin-treated groups.3 Once-daily oral amycretin appeared to have an acceptable safety profile and was tolerable in all tested doses, with TEAEs in line with what was expected from targeting GLP-1 and amylin receptors.3 All reported TEAEs occurred in a dose-proportional manner, were mild to moderate in severity, and mostly gastrointestinal. No new safety signals appeared during the study.3 Based on the findings from the oral and subcutaneous amycretin trials, Novo Nordisk recently announced it will advance amycretin into phase 3 trials to further investigate the treatment as a potential new therapeutic option for weight management.4 About amycretin Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration. Oral amycretin Phase 1 trial – The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in 144 people with overweight or obesity, with a total treatment duration of up to 12 weeks. Subcutaneous amycretin Phase 1b/2a trial – The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in 125 people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. 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 The Lancet: 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. Dahl, K, et al. (2025). Amycretin, a Novel, Unimolecular GLP-1 and Amylin Receptor Agonist: Results of a Phase 1b/2a Clinical Trial. Poster 2002-LB. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025. The Lancet: 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. Novo Nordisk Company Announcement. Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development. 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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