Current partner codePEPTIDESDE
NCT06309992·Phase 3·INTERVENTIONAL

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)

Status

Completed

Phase

Phase 3

Enrollment

218

Locations

37

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

COMBINATION_PRODUCT

Survodutide

Survodutide, pre-filled syringe

COMBINATION_PRODUCT

Placebo

Placebo matching survodutide, pre-filled syringe

Timeline

From registration to results.

  1. First posted

    Mar 13, 2024

  2. Study start

    Apr 2, 2024

  3. Primary completion

    Oct 9, 2025

  4. Study completion

    Dec 2, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Apr 30, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Key inclusion criteria: * 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 * BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-related comorbidities at screening: * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, Systolic Blood Pressure (SBP) values of ≥140 mmHg and/or Diastolic Blood Pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 antihypertensive drug to maintain a normotensive blood pressure) * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or lowdensity lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L) or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (HDL) cholesterol \<40 mg/dL (\<1.0 mmol/L) for men or HDL cholesterol \<50 mg/dL (\<1.3 mmol/L) for women * Obstructive sleep apnoea * Cardiovascular disease (e.g. heart failure with New York Heart Association (NYHA) functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure \[e.g. carotid endarterectomy and/or stent\], MI, coronary artery disease, or peripheral vascular disease) * Type 2 diabetes mellitus (T2DM) (diagnosed at least 180 days prior to screening, with glycated haemoglobin \[HbA1c\] ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol) as measured by the central laboratory at screening) * History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply. Key exclusion criteria: * Current or history of significant alcohol consumption (defined as intake of \>210 g/week in men and \>140 g/week in women on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on the investigator's judgement within the last 5 years. * Intake of medications associated with liver injury, hepatic steatosis or steatohepatitis. * History of other chronic liver diseases (e.g. viral hepatitis, autoimmune liver disease, primary biliary cholangitis , primary sclerosing cholangitis, Wilson's disease, hemochromatosis, Alpha-1 Antitrypsin (A1At) deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit 1. Participants with positive hepatitis B surface antigen (HBsAg) should be excluded. Participants treated for hepatitis C must have a negative ribonucleic acid (RNA) test at screening and also be Hepatitis C virus (HCV) RNA negative for at least 3 years prior to screening in order to be eligible for the trial. Trial participants with positive HCV antibody and no history of HCV treatment require a negative HCV RNA test at screening to be eligible for the trial. * Cirrhosis based on clinical assessment, abdominal imaging, liver histology or non-invasive tests assessed at screening (enhanced liver fibrosis (ELF) ≥11.3 or Fibrosis (FIB)-4 ≥3.48 or FibroScan® VCTE™ ≥20 kPa or MRE ≥4.68 kPa) or a history of cirrhosis. * Current decompensated liver disease or previous hepatic decompensation (ascites, spontaneous bacterial peritonitis, portal hypertension bleeding, hepatic encephalopathy, hepatorenal syndrome). * Evidence of portal hypertension (e.g. splenomegaly, oesophageal varices, or other portosystemic collateral pathways). Further exclusion criteria apply.

Study locations

37 registered sites.

Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

ARK Clinical Research

Fountain Valley, California, United States

Velocity Clinical Research-Gardena-69773

Gardena, California, United States

ARK Clinical Research

Long Beach, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Velocity Clinical Research-North Hollywood-69852

North Hollywood, California, United States

Velocity Clinical Research-Panorama City-68861

Panorama City, California, United States

Velocity Clinical Research, Santa Ana

Santa Ana, California, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Segal Drug Trials

Delray Beach, Florida, United States

Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida, United States

Velocity Clinical Research-Hallandale Beach-67888

Hallandale, Florida, United States

Nature Coast Clinical Research-Inverness-48221

Inverness, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Verus Clinical Research Corporation

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Covenant Research and Clinics, LLC

Sarasota, Florida, United States

Springfield Clinic, LLP

Springfield, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Kansas Medical Clinic PA

Topeka, Kansas, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

DSI Research Northridge LLC

Dayton, Ohio, United States

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

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