Trial · Interventional
CompletedPhase 3Registry dataA 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)
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 218 participants (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Design
- Randomized · Quadruple masking
- Countries
2 countries
United States, Spain
- Start
- 2 Apr 2024
- Primary completion
- 9 Oct 2025
- Completion
- 2 Dec 2025
- First posted
- 13 Mar 2024
- Last update posted
- 30 Apr 2026
- Conditions
- Obesity · Non-Alcoholic SteatoHepatitis (NASH)
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
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)
NCT063099922 Apr 2024 to 2 Dec 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SurvodutideCombination product
- PlaceboCombination product
Arms2
Experimental
Treatment arm
Placebo comparator
Placebo arm
Primary outcomes2
Outcomes the sponsor listed as primary.
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
Relative change (%) in body weight [kg] from baseline to Week 48
Time frame · at baseline, at week 48
Secondary outcomes(13)
Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]
Time frame · at baseline, at week 48
Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]
Time frame · at baseline, at week 48
Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no)
Time frame · at baseline, at week 48
Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels
Time frame · at baseline, at week 48
Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels
Time frame · at baseline, at week 48
Absolute change from baseline to Week 48 in waist circumference [cm]
Time frame · at baseline, at week 48
Relative change from baseline to Week 48 in waist circumference [cm]
Time frame · at baseline, at week 48
Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5)
Time frame · at baseline, at week 48
Relative change from baseline to Week 48 in HOMA-IR (FPI [mlU/L] · FPG [mmol/L]/22.5)
Time frame · at baseline, at week 48
Absolute change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)
Time frame · at baseline, at week 48
Relative change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)
Time frame · at baseline, at week 48
Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI
Time frame · at baseline, at week 48
Relative change in liver volume [mL] from baseline to Week 48 measured using MRI
Time frame · at baseline, at week 48
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedYounossi ZM, Razavi H, Sherman M, Allen AM, Anstee QM, Cusi K, Friedman SL, Lawitz E, Lazarus JV, Schuppan D, Romero-Gomez M, Schattenberg JM, Vos MB, Wong VW, Ratziu V, Hompesch M, Sanyal AJ, Loomba R. Addressing the High and Rising Global Burden of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH): From the Growing Prevalence to Payors' Perspective. Aliment Pharmacol Ther. 2025 May;61(9):1467-1478. doi: 10.1111/apt.70020. Epub 2025 Feb 18. PMID 39967239
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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