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

Official 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 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 5,533 participants

Interventions

• COMBINATION_PRODUCT: survodutide — once weekly subcutaneous injection, pre-filled syringe
• COMBINATION_PRODUCT: Placebo — once weekly subcutaneous injection, pre-filled syringe

Primary Outcomes

• 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) (up to Week 114)

Secondary Outcomes

• Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority) (up to Week 114)
• Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72 (Baseline and at Week 72)
• Absolute change in waist circumference (cm) from baseline to Week 72 (Baseline and at Week 72)
• Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline (At Baseline and at Week 72)
• 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 superiority) (up to Week 114)

Trial Locations

• Cardiology P.C., Birmingham, Alabama, United States
• AMR Daphne, Daphne, Alabama, United States
• AMR Mobile, Mobile, Alabama, United States
• Mobile Heart Specialists, PC, Mobile, Alabama, United States
• The Institute for Liver Health II DBA Arizona Clinical Trials, Chandler, Arizona, United States
• Clinical Research Institute of Arizona, LLC, Sun City West, Arizona, United States
• AMR Phoenix, Tempe, Arizona, United States
• Arizona Liver Health-Tucson-67516, Tucson, Arizona, United States
• Yuma Clinical Trials, Yuma, Arizona, United States
• Lynn Institute of the Ozarks, Little Rock, Arkansas, United States
• ...and 10 more locations

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