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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
Body mass index (BMI) ≥27 kg/m^2 at screening.
Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at week 76
Awards & highlights

SYNCHRONIZE™-2 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.Check my eligibility
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.See study design
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.

SYNCHRONIZE™-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) is 27 or higher.
Select...
I have been diagnosed with Type 2 diabetes for over 6 months.
Select...
Your HbA1c level is between 6.5% and 10%.
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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.

SYNCHRONIZE™-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Percentage change in body weight from baseline to Week 76
Secondary outcome measures
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

SYNCHRONIZE™-2 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

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,307 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies for participants in this experiment?

"Affirmative. The clinical trial portal states that this medical research, first announced on November 15th 2023 is still welcoming enrolment. 600 participants are needed for the study to be conducted across 11 distinct sites."

Answered by AI

How expansive is the geographic reach of this clinical trial?

"11 medical institutions are signing up patients for this trial, such as Lucas Research, Inc. in Morehead City, West Orange Endocrinology in Ocoee and Solaris Clinical Research in Meridian to name a few."

Answered by AI

What perils might be associated with BI 456906 6.0 mg administration?

"The safety of BI 456906 6.0 mg has been assessed as a 3, given that this is in its Phase 3 trial with multiple rounds of data confirming efficacy and security."

Answered by AI

How many individuals are taking part in this clinical experiment?

"Yes, as of November 27th 2023, the clinical trial is still actively enrolling patients. This medical study was first posted on 15th November and requires 600 participants to be recruited from 11 separate sites."

Answered by AI

Who else is applying?

What site did they apply to?
Juno Research, LLC
Other
EmVenio Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I'm still obese. Need to loss weight. I can’t lose weight. I want to lose weight.
PatientReceived 1 prior treatment
I’m 85 lbs overweight.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What can I expect? How long is the trial? How long is the trail? How long is this trial?
PatientReceived 2+ prior treatments
What is the drug? Side effects?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. EmVenio Research: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
2023. "A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066528.
All > Weight Loss Chicago > Honolulu
~400 spots leftby Dec 2025
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