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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 65 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 65 years, 1 year
  • Procedures mentioned: Injections, Phone or video check-ins, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "One group gets survodutide as an injection under the skin."
  • "The other group gets a placebo as an injection under the skin."
  • "Participants take the injections once a week."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether survodutide helps women with overweight or obesity lose weight during or after menopause. Women must be older than 18 and no older than 65. Participants get a weekly shot of survodutide or a placebo (a shot with no medicine), plus advice on diet and exercise.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were assigned female at birth, are older than 18 and no older than 65, and are going through or have finished menopause.
  • Have a BMI of 30 or higher, or a BMI of 27 or higher with at least one weight-related health problem. BMI is a measure based on height and weight.
  • Have tried at least once to lose weight by dieting without success.
  • Sign and date a form agreeing to join the study before taking part.
  • If able to become pregnant, are willing and able to use an accepted, effective birth control method.
  • Other rules for joining also apply.

Who can't join

  • Have type 1 or type 2 diabetes.
  • Have an A1c level of 6.5% or higher at screening. A1c is a blood test that measures average blood sugar.
  • Have taken medicine to treat obesity within 90 days before screening.
  • Have had a body weight change of more than 5% within 90 days before screening.
  • Other rules that may prevent joining also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (13)

AL

CA

FL

LA

MD

NC

UT