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BI 456906 for Obesity (SYNCHRONIZE™-1 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
Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
Obstructive sleep apnoea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 76
Awards & highlights
Pivotal Trial

Summary

This trial tests if a medicine helps people with overweight/obesity lose weight. Participants must meet certain criteria and receive counselling, injections and have visits/calls. Results will be compared between groups to assess effectiveness.

Who is the study for?
This trial is for adults over 18 without diabetes, with a BMI of at least 30 kg/m² or a BMI of 27 kg/m² plus weight-related health issues. Candidates should have tried and failed to lose weight through dieting before.
What is being tested?
The study tests survodutide (BI 456906) on people with obesity, comparing two different doses against a placebo. Participants will self-inject weekly for around one and a half years while also receiving lifestyle counseling.
What are the potential side effects?
Potential side effects are not detailed in the provided information but typically may include reactions at the injection site, gastrointestinal symptoms, or other common drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and can legally consent to treatment.
Select...
I have obstructive sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 76 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Percentage change in body weight from baseline to Week 76
Secondary study objectives
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
+28 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Survodutide 6.0 mgExperimental Treatment1 Intervention
Group II: Survodutide 3.6 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,856,873 Total Patients Enrolled
21 Trials studying Obesity
9,345 Patients Enrolled for Obesity
~288 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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