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

NCT07850050 · tracked via the Priya Life Science USA tracker

Sponsor

Boehringer Ingelheim

Phase

Phase 3

Started

2026-10-31

Last updated

2026-09-30

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

SurvodutidePlacebo

Survodutide: Survodutide

Placebo: Placebo matching survodutide

Study summary

This study is open to women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health problems. Participants must also have tried to lose weight by dieting at least once in the past without success. People with pre-existing diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps women with overweight or obesity lose weight.

Participants are put into 2 groups randomly, which means by chance. Participants have a 1 in 2 chance of receiving survodutide. One group gets survodutide as an injection under the skin. The other group gets a placebo as an injection under the skin. The placebo looks like the study medicine but does not contain any medicine. Participants take the injections once a week. All participants also receive advice on diet and physical activity.

Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site about 12 times and get a few phone calls from the site staff. At the study visits, doctors regularly check participants' body weight. The results are compared between the 2 groups to see whether the treatment works. The participants fill in questionnaires about their menopause symptoms and how the symptoms affect their daily life. To assess the study endpoints, participants regularly have blood samples taken. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility

Sex

FEMALE

Min age

45 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

Percentage change in body weight from baseline to Week 52 — At baseline and Week 52

Trial sites (1)

Facility	City	Region	Status
Covenant Metabolic Specialist, LLC - Riverview	Riverview	Florida

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07850050 on ClinicalTrials.gov ↗ ← All trials in the USA