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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

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
Select...
I am 18 years or older.
Select...
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
A composite of death, number HFEs (including HHFs, urgent HF visits, and unplanned outpatient visits), time to first 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 HbA1c (%) from baseline to Week 72 in trial participants with T2DM
Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline
+24 more

Side effects data

From 2021 Phase 2 trial • 413 Patients • NCT04153929
24%
Diarrhoea
20%
Nausea
14%
Vomiting
12%
Decreased appetite
8%
Dyspepsia
8%
Headache
6%
Abdominal distension
6%
Abdominal pain upper
6%
Constipation
6%
Fatigue
4%
Eructation
4%
Flatulence
4%
Lipase increased
4%
Back pain
2%
Abdominal pain
2%
Gastrooesophageal reflux disease
2%
Asthenia
2%
Hypoglycaemia
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BI 456906 0.3 mg
BI 456906 0.9 mg
BI 456906 1.8 mg
BI 456906 2.7 mg
BI 456906 1.2 Twice Weekly (2.4) mg
BI 456906 1.8 Twice Weekly (3.6) mg
Semaglutide

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 456906 6.0 mgExperimental Treatment1 Intervention
Group II: BI 456906 3.6 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 456906
2017
Completed Phase 2
~1290

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,342,411 Total Patients Enrolled
~3107 spots leftby Mar 2026
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