Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase III trial

• In SYNCHRONIZE-1, participants lost up to an average of 39.2 lb (17.8 kg) from baseline after 76 weeks of treatment with survodutide, a glucagon/GLP-1 receptor dual agonist¹
• The trial met both weight loss primary endpoints and its key secondary endpoint evaluating waist circumference, a predictor of cardiometabolic risk, together demonstrating survodutide's potential to broadly improve metabolic health¹
• In addition to these positive results, Boehringer is advancing its broad metabolic health R&D program, exploring multiple pharmaceutical approaches to weight management including oral treatments

Ingelheim, Germany. Boehringer Ingelheim today announced positive topline results from the Phase III SYNCHRONIZE-1 trial, in which survodutide (BI 456906) met the co-primary endpoints using both the efficacy and treatment-regimen estimands.^*† Adults living with obesity or overweight, without type 2 diabetes, who were treated with survodutide experienced sustained weight loss of up to an average of 16.6% after 76 weeks using the efficacy estimand, a statistically significant decrease versus 3.2% in the placebo arm (p<0.0001).¹ This level of weight loss supports survodutide’s potential as a clinically meaningful treatment option for people living with obesity or overweight.¹ Full data from the Phase III trial will be presented at the upcoming American Diabetes Association’s (ADA) 2026 Scientific Sessions in June. 

The trial met its other co-primary endpoint, with up to 85.1% of adults treated with survodutide achieving a body weight reduction of ≥5% after 76 weeks of treatment, using the efficacy estimand, versus 38.8% in the placebo arm (p<0.0001). Initial analysis indicates that body weight reduction with survodutide was driven predominantly by loss of fat tissue, with lean mass contributing only a small proportion of total weight.¹

In a key secondary endpoint, adults treated with survodutide experienced a statistically significant reduction in waist circumference – a clinical marker closely linked to visceral fat and cardiometabolic risk² – after 76 weeks versus placebo.¹ Excess visceral fat, particularly around the abdomen, is a known contributor to metabolic dysfunction and is closely connected to impaired liver function.³ As a dual glucagon/GLP‑1 receptor agonist,⁴ survodutide has the potential to address obesity while also supporting liver function, a key regulator of metabolic health.¹

“I am encouraged by the data emerging from SYNCHRONIZE-1, which continue to demonstrate survodutide’s potential as a clinically meaningful treatment option for people with the disease of obesity,” said Professor Carel le Roux, M.D., Ph.D., Professor at University College in Dublin, Ireland, and Global Coordinating Investigator of the trial. “There is an urgent need for new therapies that go beyond weight reduction alone to support meaningful improvements in metabolic health. Survodutide’s dual agonism is particularly exciting, as it offers a promising approach to addressing this significant unmet need in care.” 

Obesity is a chronic, complex metabolic disease that impacts more than 1 in 8 people worldwide in many different ways, and can have serious long-term consequences.^5,6 It is closely linked to serious conditions including liver disease, type 2 diabetes and cardiovascular disease.^7,8 Notably, up to 1 in 3 people living with obesity develop a serious liver condition called metabolic dysfunction-associated steatohepatitis (MASH), characterized by inflammation and liver damage.⁹

“Today’s SYNCHRONIZE-1 topline results strengthen our confidence in survodutide as a treatment candidate capable of addressing obesity and potentially offering targeted weight loss to help address connected conditions including liver disease,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim. “Survodutide has the potential to be the first global glucagon/GLP-1 dual agonist to help the more than 1 billion people living with obesity and MASH.” 

Survodutide’s GLP‑1 agonism decreases appetite while increasing fullness and satiety,¹⁰ while its glucagon agonism is thought to directly act on the liver to reduce hepatic fat, regulate metabolic function, resolve inflammation, and improve fibrosis.^11,12,13

As expected with GLP-1 based therapies, participants in the trial experienced gastrointestinal events, with discontinuations happening more frequently during the dose escalation phase.¹ These events were both mild to moderate in severity and temporary, with no new safety concerns observed outside of what is expected for the GLP-1 class. 

Survodutide is an investigational agent and has not been approved for use; its efficacy and safety has not been established. SYNCHRONIZE-1 is part of a comprehensive global Phase III obesity program, evaluating survodutide in people living with overweight and obesity, among key sub-populations.¹⁴ Additional trial results are expected to read out during 2026. Survodutide is also being studied in two global Phase III clinical trials LIVERAGE and LIVERAGE-Cirrhosis investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4).^15,16

Survodutide is the first in a broader portfolio of therapies being developed for people living with obesity or obesity and connected metabolic health conditions, with multiple approaches under investigation. This includes an investigational, potential first-in-class triple GLP-1, GIP, NPY2 receptor agonist peptide (BI 3034701), which will be entering Phase II in the middle of 2026, as well as additional experimental approaches including oral treatment options.

Notes to Editors

About obesity and overweight

In 2016, more than 1.9 billion adults lived with overweight — defined as a body mass index (BMI) of 25 or more.⁵ Of these, over 650 million were living with obesity — defined as a BMI of 30 or more.⁵ More than one billion people around the world are living with obesity today (1 in 8 of us) - and by 2030, that number could be more than double what it was in 2010.¹⁷ Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that present a risk to a person’s overall health.⁶

About metabolic dysfunction-associated steatohepatitis (MASH) 

MASH is a chronic and progressive liver disease caused by a build-up of fat in the liver,^18,19 and is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD).²⁰  In the U.S., cases of MASH are predicted to rise by 63% between 2015 and 2030, from 16.5 million to 27.0 million cases.²¹ MASH is a disease closely associated with interconnected cardiovascular, renal and metabolic conditions,^22,23 and it is estimated that 34% of people living with obesity also have MASH.⁹

About survodutide (BI 456906) 

Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which play a role in controlling metabolic functions.^11,12,13 Survodutide is being evaluated in a robust Phase III clinical development program, including the SYNCHRONIZE studies for people living with overweight or obesity, ^{24, 25, 26, 27, 28, 29} and the LIVERAGE studies for people living with MASH and fibrosis.^15,16

Survodutide has potential to treat adults with non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3) has been recognized by the U.S. FDA, which granted it:

• Fast Track designation in May 2021 and;³⁰
• Breakthrough Therapy designation in September 2024.³¹
  

Survodutide’s potential to treat adults with MASH and fibrosis has also been recognized by: 

• the European Medicines Agency (EMA), through acceptance to its PRIME scheme in November 2023 and;³²
• the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) which granted it Breakthrough Therapy designation in June 2024 and;
• the Taiwan Food and Drug Administration which granted it Breakthrough Designation in September 2024.

Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally. Survodutide is part of Boehringer Ingelheim’s research and development portfolio in the cardiovascular, renal and metabolic disease areas.

About the SYNCHRONIZE-1 trial (NCT06066515)

This is a Phase III, double-blind, placebo-controlled 76-week efficacy and safety trial of survodutide among 725 adults living with obesity or overweight, without type 2 diabetes.²⁴ Participants received a weekly injection of survodutide at either a 3.6mg or 6.0mg dose, or placebo.²⁴ The primary endpoints of the trial are the percentage change in body weight from baseline to Week 76, and an achievement of body weight reduction ≥5% from baseline to Week 76.²⁴

There are 31 secondary endpoints, including, achievement of ≥10, ≥15%, and ≥20% body weight reduction, and absolute changes from baseline to Week 76 in:²⁴ 

• Body weight
• Waist circumference
• Blood pressure
• Body Mass Index (BMI)
• Glycosylated hemoglobin A1c (HbA1c)
• Total cholesterol
• Liver fat content 

About the SYNCHRONIZE program  

Survodutide is also being evaluated in three other global Phase III studies for people living with overweight or obesity among key sub-populations. 

• SYNCHRONIZE-2 enrolled a sub-population of adults with type 2 diabetes.²⁵
• SYNCHRONIZE-MASLD enrolled a sub-population of adults with a confirmed or presumed diagnosis of MASH.²⁷
• SYNCHRONIZE-CVOT enrolled a sub-population of adults with cardiovascular disease, chronic kidney disease, or with risk factors for cardiovascular disease.²⁶

Survodutide is also being explored in two Phase III in-market trials:

• SYNCHRONIZE-JP in Japan and SYNCHRONIZE-CN in China are exploring survodutide for sub-populations of people living with obesity.^28,29 SYNCHRONIZE-JP explores the relative change in liver fat and body composition parameters from baseline to Week 76 when treated with survodutide versus placebo, as a secondary endpoint.²⁸

About LIVERAGE and LIVERAGE-Cirrhosis 

LIVERAGE and LIVERAGE-Cirrhosis are global Phase III clinical trials investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (fibrosis stage 4), respectively.^15,16

LIVERAGE will enroll approximately 1,800 adults, and LIVERAGE-Cirrhosis will enroll approximately 1,590 adults. In each trial, participants are randomized to receive weekly injections of either survodutide, reaching a maximum dose of 6 mg, or placebo.^15,16

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com/uk (UK and Ireland) or www.boehringer-ingelheim.com (rest of world). 

Boehringer Ingelheim’s Intended Audiences Notice 

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

^*The efficacy estimand is the estimated treatment effect assuming patients remained on treatment for the entire study duration. P-values for efficacy estimand are nominal

^†The treatment-regimen estimand is the estimated treatment effect, regardless of whether the patient adheres to the treatment, discontinues, or initiates other therapies

References

¹ Boehringer Ingelheim. Topline Results From A Study to Test Efficacy of Survodutide (BI456906) in Adults With Overweight or Obesity, Without Type 2 Diabetes. Data on file.

² Ness-Abramof R, Apovian CM. Nutr Clin Pract. 2008 Aug-Sep;23(4):397-404. 

³ Hanlon C, et al. Clin Liver Dis (Hoboken). 2022;19(3):106-110.

⁴ Zimmerman T, et al. Mol Metab 2022;66:101633.

⁵ World Obesity Federation. World Obesity Atlas 2025. Last accessed February 2026.

⁶ Bray A, et al. Obes Rev 2017;18:715-723.

⁷ Handelsman Y, et al. Metabolism 2024;159:155931.

⁸ Ndumele C, et al. Circulation 2023;148:1606–1635.

⁹ Quek J, et al. Lancet Gastroenterol Hepatol 2023;8(1):20–30.

¹⁰ Shah M, Vella A. Rev Endocr Metab Disord 2014;15:181–187.

¹¹ Sanyal AJ, et al. N Engl J Med 2024;391:311–319.

¹² Arun A, et al. Cariology in Review 2025; 

¹³ Novikoff A. Peptides 2023; 165

¹⁴ Phase III studies to investigate survodutide for people living with obesity and overweight, with and without diabetes, cardiovascular disease and chronic kidney disease. Available at https://www.boehringer-ingelheim.com/phase-3-studies-survodutide-obesity-and-overweight. Last accessed: February 2026.

¹⁵ Clinicaltrials.gov. LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/​MASH Who Have Moderate or Advanced Liver Fibrosis. Available at: https://clinicaltrials.gov/study/NCT06632444. Last accessed: February 2026. 

¹⁶ Clinicaltrials.gov. LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/​MASH Who Have Cirrhosis. Available at: https://clinicaltrials.gov/study/NCT06632457. Last accessed: February 2026.

¹⁷ World Heart Federation. Obesity. 2015. Available at: https://world-heart-federation.org/what-we-do/obesity. Last accessed February 2026.

¹⁸ Ramai D, et al. Cells 2021;10:3401.

¹⁹ “Nonalcoholic Fatty Liver Disease (NALFD) and NASH.” National Institute of Diabetes and Digestive and Kidney Diseases. Available at: www.niddk.nih.gov/health-information/liver-disease/nafld-nash. Last accessed February 2026.

²⁰ “Nonalcoholic steatohepatitis (NASH): Symptoms & complications (2023).” American Liver Foundation. Available at: liverfoundation.org/liver-diseases/fatty-liver-disease/nonalcoholic-steatohepatitis-nash/. Last accessed February 2026.

²¹ Estes C, et al. Hepatology 2017;67:123–133.

²² Musso G, et al. PLoS Med 2014;11:e1001680.

²³ Schnell O, et al. Cardiovasc Diabetol 2024;23:Article 1.

²⁴ Clinicaltrials.gov. A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (SYNCHRONIZE™-1). Available at: https://clinicaltrials.gov/study/NCT06066515. Last accessed: February 2026.

²⁵ Clinicaltrials.gov. A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight (SYNCHRONIZE™-2). Available at: https://clinicaltrials.gov/study/NCT06066528. Last accessed: February 2026. 

²⁶Clinicaltrials.gov. A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT). Available at: https://clinicaltrials.gov/study/NCT06077864. Last accessed: February 2026.

²⁷Clinicaltrials.gov. A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight. Available at: https://clinicaltrials.gov/study/NCT06309992. Last accessed: February 2026.

²⁸ Clinicaltrials.gov. A Study to Test Whether BI 456906 Helps Japanese People Living With Obesity Disease (SYNCHRONIZE™JP). Available at: https://clinicaltrials.gov/study/NCT06176365. Last accessed: February 2026.

²⁹ Clinicaltrials.gov. A Study to Test Whether BI 456906 Helps Chinese People Living With Overweight or Obesity to Lose Weight. Available at: https://clinicaltrials.gov/study/NCT06214741. Last accessed: February 2026.

³⁰ “Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH.” Boehringer Ingelheim. www.boehringer-ingelheim.com/us/press-release/boehringer-ingelheim-and-zealand-pharma-receive-fda-fast-track-designation. Last accessed: February 2026.

³¹ “Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide.” Boehringer Ingelheim. www.boehringer-ingelheim.com/human-health/metabolic-diseases/survodutide-us-fda-breakthrough-therapy-phase-3-trials-mash. Last accessed: February 2026.

³² “List of medicines currently in PRIME scheme.” European Medicines Agency. December 2023. www.ema.europa.eu/en/documents/other/list-medicines-currently-prime-scheme_en.xlsx.