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GLP-1 Receptor Agonist

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

Verified Trial
Phase 3
Waitlist Available
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.
Secondary study objectives
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)
Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score

Side effects data

From 2023 Phase 2 trial • 295 Patients • NCT04771273
65%
Nausea
41%
Diarrhoea
41%
Vomiting
23%
Headache
22%
Decreased appetite
20%
COVID-19
19%
Fatigue
17%
Constipation
16%
Abdominal distension
15%
Dyspepsia
13%
Eructation
13%
Abdominal pain
12%
Dizziness
9%
Back pain
9%
Flatulence
9%
Gastrooesophageal reflux disease
8%
Upper respiratory tract infection
8%
Hypoglycaemia
8%
Abdominal pain upper
8%
Urinary tract infection
6%
Nasopharyngitis
5%
Asthenia
5%
Cough
5%
Lipase increased
4%
Myalgia
4%
Pyrexia
4%
Arthralgia
3%
Injection site bruising
3%
Injection site pain
3%
Injection site reaction
2%
Early satiety
2%
Malaise
2%
Influenza
2%
Insomnia
1%
Carotid artery stenosis
1%
Intracranial aneurysm
1%
Angioedema
1%
Enteritis
1%
Combined pulmonary fibrosis and emphysema
1%
Hypertensive crisis
1%
Anaemia
1%
Sinusitis
1%
Hyperglycaemia
1%
Cerebral infarction
1%
Acute kidney injury
1%
Abnormal uterine bleeding
1%
Pain in extremity
1%
Rash
1%
Lumbar spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Actual Maintenance Treatment
Survodutide 2.4 mg - Actual Maintenance Treatment
Survodutide 4.8 mg - Actual Maintenance Treatment
Survodutide 6.0 mg - Actual Maintenance Treatment

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Survodutide
2021
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,552 Previous Clinical Trials
15,896,356 Total Patients Enrolled
~346 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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