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

What Was Tested

This registered phase 3 trial tested Survodutide.

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.

It had two arms (groups): Survodutide arm (experimental) and Placebo arm (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

The registry lists 600 planned participants were the target.

It was open to women only aged from 45 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm); treatment with any medication for the indication of obesity within 90 days before screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-10-31 with completion listed for 2028-07-26.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage change in body weight from baseline to Week 52 (time frame: At baseline and Week 52).

It also tracked 20 secondary outcomes, for example Key secondary endpoint: Absolute change in IWQOL-Lite CT total scale score (units on a scale) from baseline to Week 52, Absolute change in IWQOL-Lite CT physical scale score (units on a scale) from baseline to Week 52, Absolute change in IWQOL-Lite CT physical function scale score (units on a scale) from baseline to Week 52, Absolute change in IWQOL-Lite CT psychosocial scale score (units on a scale) from baseline to Week 52, Absolute change in patient-reported outcome 1 from baseline to Week 52 and Absolute change in patient-reported outcome 2 frequency from baseline to Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 600 people.

With 600 participants it is a large trial for this field.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.