SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
A Phase IIIb, Open-label, Pragmatic Study Evaluating Initiation Strategies for Survodutide, Including de Novo Use and Switching From Semaglutide or Tirzepatide, in Participants With Overweight/Obesity Without Diabetes Mellitus-SYNCHRONIZE® - START
Lead sponsor
Asset
Survodutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
2
Recruiting sites
-
Estimated enrollment
350
Study population
Obesity / overweight
Eligibility highlights
-
Primary endpoint
•Body weight
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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.
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsPercent change in body weight from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Absolute change from baseline to Week 52 in Body Mass Index (BMI) [kg/m2]
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change from baseline to Week 52 in Waist circumference [cm]
Time frame:At baseline and Week 52
change from baseline, improvement
Glycemic / diabetes
1 endpointAbsolute change from baseline to Week 52 in Glycosylated Haemoglobin A1c (HbA1c) [%]
Time frame:At baseline and Week 52
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsAbsolute change from baseline to Week 52 in Systolic Blood Pressure (SBP) [mmHg]
Time frame:At baseline and Week 52
change from baseline, improvement
Relative change from baseline to Week 52 in High Sensitivity C-Reactive Protein (hs-CRP) [mg/L]
Time frame:At baseline and Week 52
percent change from baseline, improvement
Relative change from baseline to Week 52 in Non-High-Density Lipoprotein (HDL) cholesterol [mg/dL]
Time frame:At baseline and Week 52
percent change from baseline, improvement
Relative change from baseline to Week 52 in Triglycerides [mg/dL]
Time frame:At baseline and Week 52
percent change from baseline, improvement
Other (unclassified)
6 endpointsAbsolute change from baseline in PROMIS Physical Function (PF-SF10a) score (units on a scale) to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
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
change from baseline, improvement
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
change from baseline, improvement
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
change from baseline, improvement
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
change from baseline, improvement
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
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.