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GLP-1 Receptor Agonist

BI 456906 for Diabetes and Obesity (SYNCHRONIZE™-2 Trial)

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
Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
History of at least one self-reported unsuccessful dietary effort to lose body weight
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at week 76
Awards & highlights
Pivotal Trial

Summary

This trial tests a medicine to help people with diabetes and overweight/obesity to lose weight. Participants receive medicine/placebo and counselling to help them make diet/exercise changes.

Who is the study for?
Adults over 18 with a BMI of 27 or more and type 2 diabetes, treated only with diet/exercise or specific medications, who haven't lost weight through diet changes. Excludes those with certain gastric conditions, recent significant weight change, obesity drug treatment within the last 3 months, or family history of specific thyroid cancer.
What is being tested?
The trial tests survodutide (BI 456906) for weight loss in overweight/obese adults with diabetes. Participants are randomly assigned to receive different doses of survodutide or a placebo weekly for about one and a half years while receiving dietary and exercise counseling.
What are the potential side effects?
Potential side effects aren't specified here but typically include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, possible increase in heart rate, and other effects that will be monitored by doctors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I manage my type 2 diabetes with diet, exercise, or stable medication for the last 3 months.
Select...
You have tried to lose weight through dieting in the past, but it didn't work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at week 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 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 Eating Behaviour patient reported outcome (PRO)
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)
+19 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
~288 spots leftby Dec 2025
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