SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

What Was Tested

In this phase 3 trial, researchers set out to test Survodutide.

This study is open to adults with overweight or obesity.

People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem.

Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success.

It had two arms (groups): SWITCH cohort (experimental) and INITIATION cohort (experimental).

Participants switching to survodutide.

Naive participants.

The registry classes the interventions as combination product.

Who Took Part

The registry lists 350 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 4 inclusion and 4 exclusion criteria.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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

Nothing was hidden in this open-label Survodutide study: the participants and staff both knew the treatment.

It started in 2026-11-07 with completion listed for 2028-06-25.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 13 secondary outcomes, for example Absolute change from baseline in PROMIS Physical Function (PF-SF10a) score (units on a scale) to Week 52, Absolute change from baseline in IWQOL-Lite-CT total scale score (units on a scale) to Week 52, Absolute change from baseline in IWQOL-Lite-CT physical scale score (units on a scale) to Week 52, Absolute change from baseline in IWQOL-Lite-CT physical function scale score (units on a scale) to Week 52, Absolute change from baseline in IWQOL-Lite-CT psychosocial scale score (units on a scale) to Week 52 and Absolute change from baseline to Week 52 in Body Mass Index (BMI) [kg/m2].

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Survodutide in 350 people.

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.