Clinical Trial11 Jun 2026Phase 3
A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
Boehringer Ingelheim
A phase 3 cardiovascular outcomes trial is testing survodutide (BI 456906), a dual GLP-1/glucagon receptor agonist, in 5,533 adults with overweight or obesity and established cardiovascular disease or chronic kidney disease. The randomized, double-blind, placebo-controlled study compares two doses of once-weekly subcutaneous survodutide against placebo over up to 2.25 years. This represents Boehringer Ingelheim's entry into the competitive obesity market with a differentiated dual mechanism approach. The trial aims to demonstrate cardiovascular safety non-inferiority, a regulatory requirement for obesity drugs in high-risk populations.
Strategic Signal
Boehringer Ingelheim positions survodutide as a dual GLP-1/glucagon agonist against established injectable GLP-1 monotherapy from Novo Nordisk and Eli Lilly. The cardiovascular outcomes design mirrors regulatory expectations post-Wegovy's MACE indication approval in March 2024. Success would provide Boehringer with differentiated messaging around dual mechanism benefits and cardiovascular safety data in a high-risk population where Wegovy already holds MACE reduction labeling.
Original Abstract
This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet.
The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.
Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity.
Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects. | Condition(s): Obesity | Primary endpoint(s): Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) | Enrollment: 5,531 (actual) | Phase: Phase 3 | Sponsor: Boehringer Ingelheim | Expected completion: 2026-05-08 | Status: Active Not Recruiting | Last update: 2026-06-11