1404-0040 Cardiovascular Outcomes on obese patients
Research type
Research Study
Full title
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
IRAS ID
1008576
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2022-502442-27
Clinicaltrials.gov Identifier
Research summary
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 BI 456906 (survodutide) 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 to make changes to their diet and to exercise regularly. Participants are in the study for about 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and receive 12 video calls by the site staff. 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.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0849
Date of REC Opinion
9 Nov 2023
REC opinion
Further Information Favourable Opinion