NCT06309992

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)

Multicentre, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obesity
• Non-Alcoholic SteatoHepatitis (NASH)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Survodutide	Survodutide, pre-filled syringe
COMBINATION_PRODUCT	Placebo	Placebo matching survodutide, pre-filled syringe

Timeline

• Start date: 2024-04-02
• Primary completion: 2025-10-09
• Completion: 2025-12-02
• First posted: 2024-03-13
• Last updated: 2026-04-03

Locations

37 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study