A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)

NCT06309992 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the drug survodutide can help adults with obesity or overweight and a liver condition called NASH reduce liver fat and lose weight.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 218 people

Who can join Ages 18+ · all sexes

Timeline Started 2024-04 · est. completion 2025-12

Where 37 sites · Spain, United States

What this study is testing ClinicalTrials.gov NCT06309992 ↗

Description as written by the study sponsor.

This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic liver diseases cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 14 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.

Treatments tested

Survodutide Combination Product

Survodutide, pre-filled syringe
Placebo Combination Product

Placebo matching survodutide, pre-filled syringe

Main thing measured	Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [%]
Sponsor	Boehringer Ingelheim
Conditions studied	Obesity, Non-Alcoholic SteatoHepatitis (NASH)
GLP-1 drugs	survodutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06309992 ↗