Not yet recruitingPHASE3INTERVENTIONAL

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

Hormone changes during and after menopause can make managing your weight especially challenging. The SYNCHRONIZE-HERA study is testing whether an investigational medicine called survodutide can help women who are overweight or living with obesity to lose weight. Participants are randomly assigned by chance to receive either survodutide or a placebo (a dummy injection that contains no active medicine). Injections are given once a week under the skin. Everyone in the study also receives professional advice on healthy eating and staying active. The trial lasts about 14 months and involves around 12 visits to a local study clinic. During these visits, doctors will track your weight, collect blood samples, and check your overall health and menopause symptoms. Women aged 45 to 65 who do not have diabetes and have previously tried dieting may be eligible to take part.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Boehringer Ingelheim

Enrolment target

600

Start

31 Oct 2026

Estimated completion

26 Jul 2028

Obesity

What is this study about?

Many women notice that their body shape and weight change as they go through the menopause. Drops in natural hormone levels can slow your metabolism, making it much harder to lose weight through diet and exercise alone. Carrying extra weight can also increase the chance of developing other long-term health conditions, such as high blood pressure or joint problems.

This trial is looking at a new medicine called survodutide. It works by mimicking natural hormones in the body that signal fullness to the brain and help manage how calories are burned. Researchers want to discover if weekly injections of survodutide can provide safe and lasting weight loss for women who are peri-menopausal or post-menopausal.

To find out how well survodutide works, it is compared against a placebo, which looks identical but contains no active drug. Half of the participants receive survodutide and half receive the placebo. Comparing both groups allows researchers to clearly see whether health changes and weight loss are genuinely caused by the medicine, all while providing every participant with structured lifestyle support.

Key takeaways

Tests whether a new weekly injection (survodutide) helps menopausal and post-menopausal women lose weight.
Open to women aged 45 to 65 without diabetes who have struggled with dieting in the past.
Participants have a 50/50 chance of receiving the active medicine or an inactive placebo.
Lasts around 14 months and involves roughly 12 clinic visits, regular blood tests, and health reviews.
All participants receive lifestyle guidance alongside their weekly injections.

Who may be eligible?

This study is designed for women aged between 45 and 65 who are currently going through menopause or have already completed it. To be eligible, your Body Mass Index (BMI) must be 30 or higher, or 27 and higher if you also have a weight-related health condition such as high blood pressure. You should also have tried to lose weight through dieting at least once in the past without lasting success.

You will not be able to join this study if you have type 1 or type 2 diabetes, or if your routine blood sugar checks show signs of undiagnosed diabetes. People who have used other weight-loss medicines within the last three months, or whose weight has changed by more than 5% during that time, are also unable to take part.

If you could still become pregnant, you must be willing to use an approved method of contraception during the trial. The research team will perform standard health checks to confirm whether joining the trial is safe and suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman aged between 45 and 65.
I am currently going through menopause or have already finished it.
My BMI is 30 or higher (or 27+ with a weight-related condition like high blood pressure).
I have tried to lose weight by dieting in the past.
I do not have type 1 or type 2 diabetes.
I have not taken prescription weight-loss medications in the past 3 months.

Answer every question to see your result.

What does participation involve?

If you take part, your participation will last about one year and two months (around 14 months). You will need to visit the study clinic approximately 12 times and have a few scheduled phone calls with the research team. At these visits, doctors will measure your weight, take blood samples, and ask you to fill in questionnaires about your menopause symptoms and everyday wellbeing. You will be taught how to give yourself a simple injection just under the skin once a week. You will have a 50% chance of receiving survodutide and a 50% chance of receiving a placebo. You will also receive ongoing guidance on balanced nutrition and gentle physical activity.

Potential risks and benefits

Taking part offers the possibility of losing weight and learning more about your health through regular, thorough medical check-ups and lifestyle advice. However, there is no guarantee of weight loss, particularly if you are given the placebo. Like any medication, survodutide may cause unwanted side effects, most commonly mild stomach upsets such as nausea or diarrhoea, which the study doctors will monitor closely. Taking part is completely voluntary. You are free to leave the study at any time, for any reason, and your regular NHS medical care will not be affected in any way.

Locations (16)

Flourish Research
Verified postcode
Birmingham, United States
Flourish Research
Verified postcode
Northridge, United States
Diabetes Associates Medical Group
Verified postcode
Orange, United States
Flourish Research
Verified postcode
Walnut Creek, United States
The Center for Diabetes and Endocrine Care
Verified postcode
Fort Lauderdale, United States
Jacksonville Center for Clinical Research
Verified postcode
Jacksonville, United States
Flourish Research
Verified postcode
Merritt Island, United States
West Orange Endocrinology, PA
Verified postcode
Ocoee, United States
Covenant Metabolic Specialist, LLC - Riverview
Verified postcode
Riverview, United States
Flourish Research
Verified postcode
Mandeville, United States
Flourish Research
Verified postcode
Metairie, United States
Flourish Research
Verified postcode
Bowie, United States

Common questions

Will I definitely receive the weight-loss medicine?

No. A computer places participants into groups by chance. You have a 1 in 2 (50%) chance of receiving survodutide and an equal chance of receiving a dummy injection (placebo).

How is the study medicine taken?

Both the study drug and the placebo are given as a small injection under the skin once a week. The clinic staff will show you how to do this safely at home.

Do I have to pay to join the trial?

No. All study medication, tests, and clinic appointments are provided free of charge, and trial sites often help with travel expenses.

Can I take part if I have diabetes?

No. This particular study is only for women who do not have type 1 or type 2 diabetes.

What happens if I change my mind during the study?

You can leave the trial whenever you choose. You do not need to give a reason, and your normal healthcare will continue as usual.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.