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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

SYNCHRONIZE™-1 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.Check my eligibility
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.See study design
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.

SYNCHRONIZE™-1 Trial 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.

SYNCHRONIZE™-1 Trial 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

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 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

SYNCHRONIZE™-1 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
19 Trials studying Obesity
9,187 Patients Enrolled for Obesity

Frequently Asked Questions

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

How many people are partaking in this clinical investigation?

"The clinical trial necessitates 600 enrollees who meet the criteria of eligibility. Potential participants may access this study at P3 Research Dunedin in Dunedin, Idaho and Solaris Clinical Research in Meridian, Kentucky."

Answered by AI

How many health care facilities are conducting this research trial?

"The trial is currently running in 11 different sites, including P3 Research Dunedin (Dunedin, Idaho), Solaris Clinical Research (Meridian, Kentucky) and L-MARC Research Centre (Louisville, North carolina)."

Answered by AI

Are volunteers still being recruited for this experiment?

"Clinicaltrials.gov reveals that this trial commenced on November 15th 2023 and is actively recruiting participants. The available information was recently updated on the 27th of November, 2023."

Answered by AI

Has the FDA given its seal of approval to BI 456906 3.6 mg?

"Due to the available evidence, BI 456906 3.6 mg is judged as having a safety level of 3 on our team's rating scale. This assessment takes into account both successful trials demonstrating its efficacy and multiple rounds that show it is secure for use."

Answered by AI

Who else is applying?

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

What questions have other patients asked about this trial?

How long and what all is involved in the screening process? Is there a placebo in this trial and if so what are the chances of getting the actual medication?
PatientReceived 2+ prior treatments
Where do I have to go for my screening visit. Is it free? Do I have to pay for my own doctor visits and medication related to the trial?
PatientReceived no prior treatments

Why did patients apply to this trial?

Need to lose weight. To lose 20-30 pounds. Trying to get help with obesity.
PatientReceived 2+ prior treatments
I would really like to loose weight. I have tried multiple drugs and no help.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
2023. "A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066515.
All > Fargo > Honolulu
~400 spots leftby Dec 2025
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