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)

Conditions

• Non-Alcoholic SteatoHepatitis (NASH)
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Survodutide — COMBINATION_PRODUCT
  Survodutide, pre-filled syringe
• Placebo — COMBINATION_PRODUCT
  Placebo matching survodutide, pre-filled syringe

Study Details

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.

Key Dates

Start date

Apr 2, 2024

Status verified

Apr 2026

Primary completion

Oct 9, 2025

Completion

Dec 2, 2025

Study Design

Enrollment

218 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment arm
• Placebo Comparator: Placebo arm

Primary Outcome Measure

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) [%] [ Time Frame: at baseline, at week 48 ]

Locations (33)

Related coverage on Hipa.ai

• Survodutide Phase 3 Trial for Obesity and NASH Completes Primary Data Collection
  Survodutide · Oct 9, 2025 · ClinicalTrials.gov

Find similar trials in Fountain Valley, CA

Related Studies

• Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis
  Not Yet Recruiting · Keith Pereira, MD: · St Louis, Missouri
• Inflammation, Diabetes, Ethnicity and Obesity Cohort
  Recruiting · University of California, San Francisco · San Francisco, California
• DNA Methylation and Vascular Function
  Recruiting · University of Illinois at Chicago · Chicago, Illinois
• Modifying Diet to Improve Gut Microbiome
  Not Yet Recruiting · H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida