Survodutide phase 3 results

What happened

On 1 October 2026, Boehringer Ingelheim (BI) said in a news release that the phase 3 SYNCHRONIZE-2 trial of survodutide met its co-primary endpoints. A phase 3 trial is a large, late-stage study. Endpoints are the main measures a trial is designed to test, and “co-primary” means there were two. BI named them as the change in body weight from the start of the trial and whether participants reached a set minimum reduction in body weight. BI said the full results were presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) and published at the same time in The New England Journal of Medicine.

SYNCHRONIZE-2 enrolled 755 adults living with obesity or overweight and type 2 diabetes. BI said participants received a weekly injection of survodutide at a 3.6 mg or 6.0 mg dose, or placebo (an inactive treatment), over 76 weeks. The trial was double-blind, which means neither participants nor researchers knew who received which. BI’s release has the weight and blood sugar numbers. We don’t repeat them, because one trial can’t tell you what a medicine will do for you. See our editorial policy.

On safety, BI said the most commonly reported adverse events, meaning unwanted health events that happen during a trial whether or not the medicine caused them, were gastrointestinal. It said they were mostly mild to moderate and included nausea, vomiting, diarrhea and constipation. BI also said discontinuations because of these events usually happened during dose escalation, when the dose is raised step by step, and that the study protocol allowed limited flexibility to manage adverse events. It said current and upcoming trials allow more flexible titration, the stepwise adjustment of a dose, to support tolerability.

How survodutide works

Survodutide is a glucagon/GLP-1 receptor dual agonist. An agonist is a drug that activates a receptor, the docking point on a cell that a hormone normally switches on. A dual agonist activates two. BI says survodutide activates both the glucagon and the GLP-1 receptors, which play a role in controlling metabolic functions.

Active ingredient (Canadian brands)	Receptors it activates
semaglutide (Ozempic, Wegovy)	GLP-1
tirzepatide (Mounjaro, Zepbound)	GIP and GLP-1
survodutide (investigational)	Glucagon and GLP-1
retatrutide (investigational)	GIP, GLP-1 and glucagon

A product monograph is the document that describes an authorized drug and how it works. The Wegovy monograph describes semaglutide as a GLP-1 receptor agonist, and the Mounjaro monograph describes tirzepatide as a GIP and GLP-1 receptor agonist. Survodutide shares the GLP-1 target with both. Its second target is glucagon rather than GIP. Lilly’s retatrutide, which we cover in our report on its phase 3 results, uses all three.

Glucagon is a hormone the body makes. Mounjaro’s patient information describes it as a hormone that prevents blood sugar from falling too much. The semaglutide and tirzepatide monographs describe those medicines as lowering glucagon, in a way that depends on blood sugar levels. Survodutide, by contrast, activates the glucagon receptor, according to BI. BI notes that glucagon is traditionally associated with raising blood sugar, and says the specific balance of glucagon and GLP-1 receptor activity may help preserve blood sugar control. That is BI’s explanation, and we haven’t verified it independently.

BI describes survodutide as designed to improve blood sugar control, reduce appetite and support reductions in liver fat. That describes the design, not a result we are reporting. We describe where each medicine acts. We don’t compare what they do for people.

Why survodutide is also tested in liver disease

MASH, short for metabolic dysfunction-associated steatohepatitis, is a form of fatty liver disease. The liver holds excess fat and is also inflamed and damaged. The US National Institute of Diabetes and Digestive and Kidney Diseases says that inflammation and damage can cause fibrosis, or scarring, of the liver, and may lead to cirrhosis, in which the liver is scarred and permanently damaged.

BI’s release says survodutide is designed to support reductions in liver fat. It also says MRI-based body composition assessments in SYNCHRONIZE-2 showed reductions in visceral fat, the fat around the internal organs, and in liver fat. BI runs two phase 3 trials in liver disease. LIVERAGE tests survodutide in adults with MASH and fibrosis stages 2 or 3. LIVERAGE-Cirrhosis tests it in adults with compensated MASH cirrhosis, which BI classes as fibrosis stage 4. Both trials are ongoing, and we have no results from them to report.

What it means in Canada

Health Canada’s list of new drug submissions under review does not include survodutide. A new drug submission is a company’s formal request for Health Canada to authorize a new medicine. The list we read on 3 October 2026 was current as of 31 August 2026, and Health Canada last modified the page on 24 September 2026. A submission accepted into review after 31 August 2026 wouldn’t show yet.

BI’s release states that survodutide has not been approved for use and that its efficacy and safety have not been established. It gives no date for any regulatory submission, in Canada or elsewhere. AllSci’s coverage doesn’t give one either.

If you see survodutide offered for sale online or by a clinic, ask a pharmacist or prescriber about it before you buy or use it. For medicines you can get now, see our price pages and coverage pages.

What hasn’t changed

Availability, price and coverage. We list no price for survodutide and have no coverage information for it, because we haven’t found a Canadian product to price or a plan rule to read. Our coverage pages cover the GLP-1 medicines that are available now.

What one trial covers. SYNCHRONIZE-2 studied adults with obesity or overweight and type 2 diabetes. It doesn’t tell us about other groups of people, and BI’s liver trials have no results yet.

Your own care. If you’re thinking about changing a medicine, talk to your prescriber or pharmacist first.

What happens next

BI said it expects to present results from SYNCHRONIZE-CVOT, its cardiovascular outcomes trial, later in 2026. A cardiovascular outcomes trial follows participants over time to see whether heart and blood vessel problems occur. BI said the results will further clarify survodutide’s cardiovascular safety. BI also said it has launched SYNCHRONIZE-T2D, a phase 3 trial of survodutide’s effect on blood sugar control in adults with type 2 diabetes.

The LIVERAGE and LIVERAGE-Cirrhosis trials are continuing. Neither BI’s release nor AllSci’s coverage gives a regulatory submission date, and we won’t guess at a Canadian one. We’ll update this article if Health Canada’s list shows a survodutide submission. For a different medicine from a different company, see our report on retatrutide’s phase 3 results.