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

NCTNCT07855900Other id1404-0127Other idU1111-1339-5379Other id2026-527093-36-00

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Overview

Status: Not yet recruiting
Phase: Phase 3
Enrollment: 350 participants (estimated)
Sponsor: Boehringer Ingelheim · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 7 Nov 2026 (estimated)
Primary completion: 25 Jun 2028 (estimated)
Completion: 25 Jun 2028 (estimated)
First posted: 2 Oct 2026
Last update posted: 2 Oct 2026
Conditions: Obesity

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
NCT07855900
est. 7 Nov 2026 to est. 25 Jun 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SurvodutideCombination product

Arms2

Experimental
SWITCH cohort
Participants switching to survodutide
Experimental
INITIATION cohort
Naive participants

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent change in body weight from baseline to Week 52
Time frame · 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
Time frame · At baseline and Week 52
Registry description
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) measure assesses self-reported capability in performing a range of physical activities. It evaluates perceived functioning of the upper extremities, lower extremities (mobility), and central body regions (neck, back), as well as activities of daily living. The 24-item PROMIS PF yields a total score reflecting physical function.
Absolute change from baseline in PROMIS Ability to Participate in Social Roles and Activities SF8a total score (units on a scale) to Week 52
Time frame · At baseline and Week 52
Registry description
The PROMIS Ability to Participate in Social Roles and Activities measure assesses perceived ability to perform usual social, family, leisure, and work roles. Items address limitations in engaging in routine activities, and responses are reverse-scored so that higher scores reflect better ability and fewer limitations. The 35-item measure generates a single Ability-to-Participate score.
Absolute change from baseline in IWQOL-Lite-CT total scale score (units on a scale) to Week 52
Time frame · At baseline and Week 52
Registry description
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Absolute change from baseline in IWQOL-Lite-CT physical scale score (units on a scale) to Week 52
Time frame · At baseline and Week 52
Registry description
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Absolute change from baseline in IWQOL-Lite-CT physical function scale score (units on a scale) to Week 52
Time frame · At baseline and Week 52
Registry description
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Absolute change from baseline in IWQOL-Lite-CT psychosocial scale score (units on a scale) to Week 52
Time frame · At baseline and Week 52
Registry description
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Absolute change from baseline to Week 52 in Body Mass Index (BMI) [kg/m2]
Time frame · At baseline and Week 52
Absolute change from baseline to Week 52 in Waist circumference [cm]
Time frame · At baseline and Week 52
Absolute change from baseline to Week 52 in Systolic Blood Pressure (SBP) [mmHg]
Time frame · At baseline and Week 52
Registry description
Three measurements will be captured at each scheduled assessment time point. The mean of these 3 measurements \[or the mean of the available measurements if fewer\] will be calculated and used in the endpoint definition.
Absolute change from baseline to Week 52 in Glycosylated Haemoglobin A1c (HbA1c) [%]
Time frame · At baseline and Week 52
Relative change from baseline to Week 52 in High Sensitivity C-Reactive Protein (hs-CRP) [mg/L]
Time frame · At baseline and Week 52
Relative change from baseline to Week 52 in Non-High-Density Lipoprotein (HDL) cholesterol [mg/dL]
Time frame · At baseline and Week 52
Relative change from baseline to Week 52 in Triglycerides [mg/dL]
Time frame · At baseline and Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: 1. 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 2. History of at least one self-reported unsuccessful dietary effort to lose body weight 3. 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 4. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control as provided in the protocol Further inclusion criteria apply. Exclusion criteria: 1. Body weight change (self-reported) \>2.5% during run-in period before screening 2. 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) 3. Hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening 4. History of Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) or treatment with glucose-lowering agent (for the purpose of treating diabetes) started within 3 months before the screening visit up to and including the baseline visit Further exclusion criteria apply.

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