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 novonordisk-us.com, 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 semaglutide.com.
Contacts for further information
Media:Liz Skrbkova (US)+1 609 917 0632USMediaRelations@novonordisk.com
Ambre James-Brown (Global)+45 3079 9289Globalmedia@novonordisk.com
Investors:Frederik Taylor Pitter (US)+1 609 613 0568fptr@novonordisk.com
Jacob Martin Wiborg Rode (Global)+45 3075 5956jrde@novonordisk.com
Sina Meyer (Global)+45 3079 6656 azey@novonordisk.com
Ida Schaap Melvold (Global)+45 3077 5649 idmg@novonordisk.com
Max Ung (Global)+45 3077 6414mxun@novonordisk.com
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: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.
Centers for Disease Control and Prevention. Why it matters. Last accessed: June 2025. Available at: https://www.cdc.gov/obesity/php/about/?CDC_AAref_Val=https://www.cdc.gov/obesity/about-obesity/why-it-matters.html.
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: https://www.cdc.gov/nchs/products/databriefs/db508.htm.
© 2025 Novo Nordisk All rights reserved. US25SEMO01477 June 2025
View original content to download multimedia:https://www.prnewswire.com/news-releases/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-302487500.html
SOURCE NOVO NORDISK INC.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
29 minutes ago
- Yahoo
The Best Late-Night Snack to Lower Cholesterol, According to Dietitians
Reviewed by Dietitian Karen Ansel, M.S., RDNMillions of Americans have high cholesterol, which can lead to heart disease. A bedtime snack rich in fiber and plant protein may help lower cholesterol. For a cholesterol-lowering late-night snack, our Chia Seed Pudding checks all the you have high cholesterol, you're not alone. According to the Centers for Disease Control and Prevention, millions of Americans have high cholesterol (aka hyperlipidemia). This condition, defined as total blood cholesterol levels higher than 200 mg/dL, is a leading risk factor for heart disease. However, that doesn't mean you're destined for heart troubles. 'Keeping cholesterol levels in a healthy range helps reduce the risk of plaque buildup in the arteries, which can lead to heart disease over time,' says Kathleen Benson, RDN, CSSD, CPT. Of course, healthy meals are the foundation of a cholesterol-lowering diet. But snacks can help, too—even the ones you eat before bed, like our Chia Seed Pudding. It's loaded with ingredients that can help reduce cholesterol. Yet, it's light and satisfying enough that it won't mess with your sleep. No wonder dietitians are huge fans. Here's how it can help keep your heart healthy. One of the myriad benefits of enjoying a high-fiber diet is that it can help lower cholesterol levels. 'When I have a client trying to manage high cholesterol levels, we focus on getting more fiber and healthier fats in their diet,' says Meggie Connelly, M.S., RD, LDN. Filled with fiber-rich chia seeds, our Chia Seed Pudding delivers a hefty 11 grams of fiber per serving. Chia seeds contain a mix of both soluble and insoluble fiber. But it's their soluble fiber that's behind chia's cholesterol-lowering powers. The reason? Soluble fiber can absorb some of the cholesterol in your gut, removing it from the body before it can cause trouble. Interestingly, research has shown that cholesterol from food doesn't always affect your blood cholesterol levels. The real culprit is saturated fat, found mainly in full-fat dairy, red and processed meat, lard and ghee. Saturated fat tells your liver to rev up its cholesterol production, which provides far more cholesterol than the amount we absorb from food. Since this chia pudding is made with almond milk, it contains merely 1 gram of saturated fat per serving. If almond milk isn't your thing, feel free to sub in another plant-based milk like soy, cashew or oat milk or low-fat cow's milk. Just steer clear of coconut milk and full-fat cow's milk, which are both high in saturated fat. Whether you have high cholesterol or not, choosing a late-night snack that contains some protein is the key to staying satiated all night long. 'This will help you feel full during the night and help control blood sugar levels so you're not starving by the morning,' says Brannon Blount, M.S., RDN. Each serving of this chia pudding delivers 7 grams of protein. And not just any kind of protein. All of its protein is plant protein, which has been linked to better heart health. It's so beneficial that the American Heart Association recommends getting most of our protein from plant sources like the chia seeds and nuts in this recipe. A combination of fiber and protein. Consider this the magic duo. 'Fiber and protein combined, or paired together with an assortment of foods, can support steady blood sugar and satiety,' Benson says. That's important because chronically high blood sugar levels can lead to diabetes, which increases heart disease risk. Ingredients that are easy to digest. When you're trying to get some quality zzz's, the last thing you need to eat is something that will upset your tummy or delay sleep even further. Choose something light, easy to digest and satisfying, yet low in fat and added sugars. In addition to chia pudding, oatmeal, popcorn and cereal with low-fat milk are all great options. Something simple to assemble. After a long day, it's normal to experience some decision fatigue. But, instead of reaching for something with empty calories (we're looking at you, bag of chips), choose something nutrient-dense that you can easily whip up. 'Your late-night snack needs to be quick and easy to put together, like a banana and nut butter, or a peanut butter and sliced strawberry sandwich on whole-grain bread. Or make your chia pudding in advance,' says Connelly. 'If you have to spend 30 minutes making your late-night snack, it's not going to be something you do consistently.' Late-night snacking may get a bad rap, but if you didn't eat enough during the day, a little nibble before bed might help you fall and stay asleep. That said, if you have high cholesterol, there are some considerations to keep in mind. If cholesterol is an issue, dietitians recommend choosing a snack that's rich in fiber, low in saturated fat and contains some protein. Our Chia Seed Pudding checks all the boxes. So, whip some up today. You can double (or even quadruple) the recipe. And it will stay fresh in your fridge for up to three days for a hassle-free bedtime snack your heart will thank you for. Read the original article on EATINGWELL
CBS News
42 minutes ago
- CBS News
Allegheny County issues code red heat advisory due to impending heat wave
Allegheny County will activate a code red heat advisory beginning Sunday, June 22, through Wednesday, June 25, due to extreme forecasted heat that could pose risks to vulnerable residents. The activation is based on the National Weather Service and Centers for Disease Control's HeatRisk tool, which considers how unusual and prolonged the heat is for this time of year, as well as the potential for serious health impacts, according to a provided news release from county officials. "We've always responded to heat emergencies, but this year we're being more systematic," said Erin Dalton, Director of the Allegheny County Department of Human Services. "Senior centers will now more consistently extend their hours on Code Red days, and we'll be assessing conditions to potentially expand overnight shelter when extreme heat persists into the night. This pilot approach will help us learn what works best to keep people safe." Residents are encouraged to check on neighbors, friends, and family, especially those who are older or medically vulnerable. Allegheny County Emergency Services is reminding residents that heat is the leading weather-related cause of death nationwide, surpassing the fatalities caused by floods, tornadoes, hurricanes, and lightning. Tips to keep yourself safe during extreme heat include drinking plenty of water to stay hydrated, even if you are not thirsty; keeping cool by using wet towels, putting feet in cool water, and taking cool showers; spend as much time as possible in cool or air-conditioned buildings; staying out of the sun during the hottest part of the day; wear sunscreen and hats with other loose-fitting clothing; and never leave pets or children in vehicles. Cooling centers opening In response to the forecasted temperatures, CitiParks will open six cooling centers on Sunday, June 22, through Wednesday, June 25. When operating as a cooling center, senior centers will welcome residents of any age. The Department of Human Services is also taking additional actions, including outreach to older adults, children, and people experiencing homelessness, in coordination with the City of Pittsburgh and other municipalities, according to a news release. On Sunday, cooling centers will be open from 12 p.m. to 6 p.m. From Monday through Wednesday, the centers will operate from 8 a.m. to 7 p.m. A full list of operational cooling centers is below. Beechview Healthy Active Living Community Center 1555 Broadway Avenue Pittsburgh, Pa. 15216 Brighton Heights Healthy Active Living Community Center 3515 McClure Avenue Pittsburgh, Pa. 15212 Greenfield Healthy Active Living Community Center 745 Greenfield Avenue Pittsburgh, Pa. 15217 Homewood Healthy Active Living Community Center 7321 Frankstown Road Pittsburgh, Pa. 15208 Sheraden Healthy Active Living Community Center 720 Sherwood Avenue Pittsburgh, Pa. 15204 South Side Healthy Active Living Community Center 12th and Bingham Streets Pittsburgh, Pa. 15203
Yahoo
an hour ago
- Yahoo
OBYGNS, Share With Us A Fascinating But Not Well-Known Fact About Women's Health
Our knowledge of women's healthcare has come a long way, but there's still so much we don't know or know little about. That said, if you're an OBYGN, we want to know: what's a fascinating fact about women's bodies or health that most people might not be aware of? Maybe you want people to know that the vagina is self-cleaning, so people don't need to worry about using scented soaps or other products inside the vagina, as it can mess up the pH. Related: Your Wedding Preferences Will Reveal Your Inner Disney Princess Maybe you find it fascinating how the cervix changes during ovulation. To make it easier for sperm to enter, the cervix becomes softer and opens up slightly. Related: Most People Can't Ace This US Geography Good Luck! Or maybe you find that most women don't know that orgasming can help reduce menstrual cramping by increasing blood flow and relaxing the muscles. If you're an OBGYN, whatever knowledge you want to drop, we want to hear it. For a chance to be featured in an upcoming BuzzFeed Community post, tell us your fact in the comments, or you can anonymously submit it using the form below! Also in Community: Your McDonald's UK Order Will Reveal The Perfect Summer Activity For You Also in Community: I'm Sorry, But Every American Should Be Able To Pass This Basic-Level US States Quiz Also in Community: Which Disney Princess Are You? Build A $500 Outfit To Find Out
