Survodutide for weight loss in women around or after menopause with overweight or obesity
Tests survodutide for weight loss in women with overweight or obesity during or after menopause.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Glasgow and Leicester, United KingdomSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 65 years old?
Source: NCT07850050, who can take part
Where in United Kingdom
- Glasgow Royal InfirmaryGlasgow, United KingdomNo longer taking part
- Leicester General HospitalLeicester, United KingdomNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07850050EU 2026-527092-29-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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; Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM); Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1).