BI 456906 for Obesity

Verified Trial

Phase 3

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You are 18 years or older, and identify as either male or female.

You are diagnosed with cardiovascular disease or chronic kidney disease.

Must not have

Treatment with any medication for the obesity indication within 3 months before screening; previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 114

Awards & highlights

Pivotal Trial

Summary

This trial tests a medicine called survodutide, which is injected regularly to help people with obesity or overweight lose weight. It focuses on adults with a high BMI and related health issues who have tried dieting before. The goal is to see if survodutide can reduce serious heart problems and improve overall health.

Who is the study for?

Adults over 18 with a BMI of 27 kg/m2 or more can join this trial if they have cardiovascular disease, chronic kidney disease, or at least two weight-related health issues. They should have tried dieting to lose weight before.

What is being tested?

The study tests BI 456906 (survodutide) against a placebo for its effects on cardiovascular safety in overweight individuals. Participants are split into three groups and receive either survodutide or placebo alongside diet and exercise counseling.

What are the potential side effects?

Potential side effects of survodutide are not detailed here but will be monitored throughout the study as participants visit the site up to 21 times and attend video calls to check their cardiovascular and overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older.

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I have been diagnosed with heart disease or chronic kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 114

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 114

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 114 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline

Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline