- In the SYNCHRONIZE-1 trial, participants receiving the glucagon/GLP-1 dual receptor agonist survodutide for 76 weeks achieved a mean weight reduction of up to 39.2 pounds (17.8 kilograms) from baseline.1
- The trial met both primary weight loss endpoints and a key secondary endpoint assessing waist circumference—a predictor of cardiometabolic risk—demonstrating survodutide’s potential to improve overall metabolic health.1
- In addition to these positive outcomes, Boehringer Ingelheim is advancing its broad metabolic health R&D program, exploring multiple weight management treatment options, including oral formulations.
Ingelheim, GermanyApril 28, 2026 /PRNewswire/ — Today, Boehringer Ingelheim announced positive top-line results from its Phase III SYNCHRONIZE-1 clinical trial. In this trial, the glucagon/GLP-1 dual agonist survodutide (BI 456906) met the co-primary endpoints using both efficacy estimand and treatment policy estimand approaches. When assessed using the efficacy estimand, adults with obesity or overweight but without type 2 diabetes who received survodutide achieved a mean sustained weight reduction of up to 16.6% over 76 weeks of treatment, compared to 3.2% in the placebo group, with a statistically significant difference (p<0.0001).1 This level of weight loss demonstrates survodutide’s potential as a clinically valuable treatment option for people with obesity or overweight.1 Full data from the Phase III trial will be presented at the American Diabetes Association (ADA) 2026 Scientific Sessions in June.
The trial also met another co-primary endpoint: using the efficacy estimand, after 76 weeks of treatment, up to 85.1% of adults receiving survodutide achieved a weight reduction of ≥5%, compared to 38.8% in the placebo group (p<0.0001). Preliminary analysis indicates that weight loss with survodutide was primarily driven by a reduction in fat mass, with lean mass loss accounting for only a small portion of total weight loss.1
Among key secondary endpoints, adults treated with survodutide showed a statistically significant reduction in waist circumference after 76 weeks compared to placebo1, a clinical measure closely associated with visceral fat and cardiometabolic risk.2 Excess visceral fat, particularly around the abdomen, is a known contributor to metabolic dysfunction and is strongly linked to impaired liver function.3 As a glucagon/GLP-1 dual receptor agonist, survodutide not only holds promise for treating obesity but also supports liver function as a key regulator of metabolic health.1
“I am encouraged by the data from the SYNCHRONIZE-1 trial, which continue to demonstrate survodutide’s potential as a clinically meaningful treatment option for obesity,” said Dr. Carel le Roux, global coordinating investigator of the study and professor at University College Dublin, Ireland. “There is an urgent need for new therapies that not only reduce weight but also genuinely improve metabolic health. Survodutide’s dual agonist mechanism is particularly exciting, as it offers a highly promising approach to addressing this significant unmet medical need.”
Obesity is a complex chronic metabolic disease affecting more than one in eight people worldwide in various ways and can lead to serious long-term consequences.5,6 It is closely linked to severe conditions such as liver disease, type 2 diabetes, and cardiovascular disease.7,8 Notably, one in three people with obesity will develop a severe liver disease called metabolic dysfunction-associated steatohepatitis (MASH), characterized by inflammation and liver damage.9
“Today’s SYNCHRONIZE-1 top-line results strengthen our confidence that survodutide, as a treatment candidate, has the ability to address obesity and potentially help address related diseases, including liver disease, through targeted weight loss,” said Shashank Deshpande, Global Executive Board Chairman and Head of Human Pharma at Boehringer Ingelheim. “Survodutide has the potential to become the world’s first glucagon/GLP-1 dual agonist to help over one billion people living with obesity and MASH.”
Survodutide’s GLP-1 agonism reduces appetite while increasing satiety;10 its glucagon agonism acts directly on the liver to reduce liver fat, regulate metabolic function, resolve inflammation, and improve fibrosis.11,12,13
As expected with GLP-1 class therapies, participants experienced gastrointestinal adverse events during the dose escalation phase, with more frequent discontinuations.1 These events were mild to moderate in severity and transient, with no new safety concerns identified beyond those expected for the GLP-1 class.
Survodutide is an investigational drug and has not been approved for use; its efficacy and safety have not been established. SYNCHRONIZE-1 is part of a broad global Phase III obesity program designed to evaluate survodutide in people with obesity and overweight, including key subgroups.14 Additional trial results are expected to be released during 2026. Survodutide is also being studied in two global Phase III clinical trials, LIVERAGE and LIVERAGE-Cirrhosis, to investigate its efficacy and safety in adults with MASH and stage 2 or 3 fibrosis, and in adults with MASH and compensated cirrhosis (stage 4 fibrosis).15,16
About Overweight and Obesity
In 2016, more than 1.9 billion adults worldwide were overweight—defined as a body mass index (BMI) ≥25.5 Of these, over 650 million were obese—defined as a BMI ≥30.5 Currently, more than one billion people globally have obesity (approximately one in eight people); by 2030, this number could more than double compared to 2010.17 Overweight and obesity are complex chronic diseases characterized by abnormal or excessive fat accumulation that poses a risk to an individual’s overall health.
About Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic dysfunction-associated steatohepatitis (MASH) is a chronic, progressive liver disease caused by fat accumulation in the liver18,19 and is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD).20 In the United States, MASH cases are projected to increase by 63% between 2015 and 2030, from approximately 16.5 million to 27 million cases.21
MASH is closely associated with various interrelated conditions, including cardiovascular, renal, and metabolic diseases,22,23 and it is estimated that approximately 34% of people with obesity also have MASH.9
About Survodutide (BI 456906)
Survodutide is a glucagon/GLP-1 receptor dual agonist that simultaneously activates the glucagon receptor and the GLP-1 receptor, both of which play important roles in regulating the body’s metabolic function.11,12,13 Survodutide is currently being evaluated in a comprehensive Phase III clinical development program, including the SYNCHRONIZE studies for people with overweight or obesity24,25,26,27,28,29 and the LIVERAGE studies for people with MASH and liver fibrosis.15,16
Survodutide has the potential to treat adults with MASH without cirrhosis and with moderate or severe (stage 2 or 3) liver fibrosis and has received recognition from the U.S. Food and Drug Administration (FDA), including:
- Fast Track designation, granted in May 202130;
- Breakthrough Therapy designation, granted in September 2024.31
Survodutide’s potential in treating MASH and liver fibrosis has also been recognized by the following regulatory authorities:
- European Medicines Agency (EMA): Accepted into the PRIME (Priority Medicines) scheme in November 202332;
- China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE): Granted Breakthrough Therapy designation in June 2024;
- Taiwan Food and Drug Administration (TFDA): Granted Breakthrough Therapy designation in September 2024.
Survodutide is licensed to Boehringer Ingelheim by Zealand Pharma and is exclusively developed and commercialized globally by Boehringer Ingelheim. Survodutide is a key component of Boehringer Ingelheim’s pipeline in cardiovascular, renal, and metabolic diseases.
The trial also includes 31 secondary endpoints, including the proportion achieving weight loss ≥10%, ≥15%, and ≥20%, as well as absolute changes from baseline to week 76 in the following measures:24
- Body weight
- Waist circumference
- Blood pressure
- Body mass index (BMI)
- Glycated hemoglobin (HbA1c)
- Total cholesterol
- Liver fat content
About the SYNCHRONIZE Program
Survodutide is also being evaluated in three additional global Phase III studies targeting key subgroups of people with overweight or obesity:
- SYNCHRONIZE-2 includes a subgroup of adults with type 2 diabetes.25
- SYNCHRONIZE-MASLD includes a subgroup of adults with confirmed or suspected MASH.27
- SYNCHRONIZE-CVOT includes a subgroup of adults with cardiovascular disease, chronic kidney disease, or risk factors for cardiovascular disease.26
Additionally, survodutide is being evaluated in two market-specific Phase III trials:
- SYNCHRONIZE-JP in Japan and SYNCHRONIZE-CN in China are designed to explore survodutide in subgroups of people with obesity.28,29 SYNCHRONIZE-JP includes “relative change in liver fat and body composition parameters from baseline to week 76 with survodutide compared to placebo” as a secondary endpoint.28
About the LIVERAGE and LIVERAGE-Cirrhosis Trials
LIVERAGE and LIVERAGE-Cirrhosis are global Phase III clinical trials designed to investigate the efficacy and safety of survodutide in adults with MASH and stage 2 or 3 fibrosis, and in adults with MASH and compensated cirrhosis (stage 4 fibrosis), respectively.15,16
The LIVERAGE trial plans to enroll approximately 1,800 adults, and the LIVERAGE-Cirrhosis trial plans to enroll approximately 1,590 adults. In both trials, participants will be randomized to receive weekly injections of survodutide (up to a maximum dose of 6 mg) or placebo.15,16
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