SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

NCT07855900 | Not Yet Recruiting Phase 3 FDA Drug

• 3 other identifiers: 1404-0127U1111-1339-53792026-527093-36-00
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open to adults with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success. The purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity lose weight. This study has 2 groups. The groups differ based on their starting dose and whether they have used similar weight-loss medicines before. Participants are put into one of the 2 groups, but everyone in the study receives the study medicine, survodutide. Participants take the medicine as an injection under the skin once a week. The dose of the medicine is slowly increased over time and then kept at a steady level. If a participant has side effects, such as stomach problems, the study doctor can adjust their dose. Participants are in the study for about 1 year and 2 months. During this time, they visit the study site about 12 times. The study staff will also contact the participants by phone or video call for extra check-ins. The participants fill in questionnaires about their physical abilities, social activities, and how their weight affects their daily and emotional life. During the study, doctors regularly measure body weight to see whether the treatment works. They also check waist size, blood pressure, and take blood and urine samples. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from baseline to Week 52

  At baseline and Week 52

Secondary Outcomes (13)

• Absolute change from baseline in PROMIS Physical Function (PF-SF10a) score (units on a scale) to Week 52

  At baseline and Week 52

• Absolute change from baseline in PROMIS Ability to Participate in Social Roles and Activities SF8a total score (units on a scale) to Week 52

  At baseline and Week 52

• Absolute change from baseline in IWQOL-Lite-CT total scale score (units on a scale) to Week 52

  At baseline and Week 52

• Absolute change from baseline in IWQOL-Lite-CT physical scale score (units on a scale) to Week 52

  At baseline and Week 52

• Absolute change from baseline in IWQOL-Lite-CT physical function scale score (units on a scale) to Week 52

  At baseline and Week 52

Study Arms (2)

SWITCH cohort

EXPERIMENTAL

Participants switching to survodutide

Combination Product: Survodutide

INITIATION cohort

EXPERIMENTAL

Naive participants

Combination Product: Survodutide

Interventions

Survodutide COMBINATION_PRODUCT

Survodutide

Also known as: BI 456906

INITIATION cohort; SWITCH cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently

You may not qualify if:

• Body weight change (self-reported) \>2.5% during run-in period before screening
• Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
• Hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Covenant Metabolic Specialist, LLC - Riverview

Riverview, Florida, 33578, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 7, 2026
• Primary Completion (Estimated): June 25, 2028
• Study Completion (Estimated): June 25, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (1)