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)

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

Age range

45–65 years

Sex

Female

Healthy volunteers

No