SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
A Multicentre, Randomised, Double-blind, Placebo-controlled 52-week, Phase IIIb Trial to Evaluate the Efficacy and Safety of Survodutide in Peri- and Post-menopausal Women With Overweight or Obesity (SYNCHRONIZE®-HERA)
Lead sponsor
Asset
Survodutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
16
Recruiting sites
-
Estimated enrollment
600
Study population
Obesity / overweight
Eligibility highlights
•Female
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. Signed and dated written informed consent in accordance with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
2. Female (sex assigned at birth) with age >18 years at the time of screening
3. History of at least one self-reported unsuccessful dietary effort to lose body weight
4. Women of Childbearing Potential (WOCBP) must be ready and able to use at least an acceptable effective contraceptive method of birth control Further inclusion criteria apply.
Exclusion criteria
1. Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
2. Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1)
3. Treatment with any medication for the indication of obesity within 90 days before screening
4. Body weight change (self-reported) >5% within 90 days before screening (Visit 1) Further exclusion criteria apply.
Endpoints (21)
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
6 endpointsPercentage change in body weight from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
Time frame:At baseline and Week 52
threshold achievement, improvement
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52
Time frame:At baseline and Week 52
threshold achievement, improvement
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52
Time frame:At baseline and Week 52
threshold achievement, improvement
Absolute change in Body Mass Index (BMI) (kg/m2) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute in waist circumference (cm) from baseline to Week 52
Time frame:At baseline and Week 52
descriptive
Glycemic / diabetes
1 endpointAbsolute change in Glycosylated Haemoglobin A1c (HbA1c) (%) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Cardiometabolic biomarkers
6 endpointsAbsolute change in systolic blood pressure (mmHg) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Relative change in Low-Density Lipoprotein (LDL) cholesterol (%) from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Relative change in triglycerides (%) from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Relative change in High-Density Lipoprotein (HDL) (%) from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Relative change in non-HDL (%) from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Relative change in high sensitivity C-reactive protein (hsCRP) (%) from baseline to Week 52
Time frame:At baseline and Week 52
percent change from baseline, improvement
Patient-reported / QoL
3 endpointsAbsolute change in patient-reported outcome 1 from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change in patient-reported outcome 2 frequency from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change in patient-reported outcome 2 severity from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Other (unclassified)
5 endpointsKey secondary endpoint: Absolute change in IWQOL-Lite CT total scale score (units on a scale) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change in IWQOL-Lite CT physical scale score (units on a scale) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change in IWQOL-Lite CT physical function scale score (units on a scale) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change in IWQOL-Lite CT psychosocial scale score (units on a scale) from baseline to Week 52
Time frame:At baseline and Week 52
change from baseline, improvement
Absolute change in PROMIS Physical Function score (PF-SF10a) (units on a scale) from baseline 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.