NCT07850050Not yet recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 26 Jul 2028
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity
- NCT number
- NCT07850050
- EU CT number
- 2026-527092-29-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 31 Oct 2026 to the primary completion date, 26 Jul 2028
- 16 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any medication for the indication of obesity within 90 days before screening
- Body weight change (self-reported) \>5% within 90 days before screening (Visit 1) Further exclusion criteria apply.
Other illness
- Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
Lab values
- Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1)
Who the study is looking for
- 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
- Female (sex assigned at birth) with age \>18 years at the time of screening
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- 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.
Age in the registry: 45 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Glasgow Royal Infirmary Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Bowie | United States | Unknown status |
| The Center for Diabetes and Endocrine Care Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Mandeville | United States | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Merritt Island | United States | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| West Orange Endocrinology, PA Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| McKay-Dee Hospital Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| Diabetes Associates Medical Group Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Covenant Metabolic Specialist, LLC - Riverview Coordinator of this site? Confirm its status | Riverview | United States | Unknown status |
| Flourish Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.