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 Phase 3 DMC FDA Drug

• 3 other identifiers: 1404-00562023-505303-23-00U1111-1299-9925
• Study Type: interventional
• Target: 218
• Locations: 2 countries
• Sites: 37

Brief 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)

Outcome Measures

Primary Outcomes (2)

• 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) [%]

  at baseline, at week 48

• Relative change (%) in body weight [kg] from baseline to Week 48

  at baseline, at week 48

Secondary Outcomes (13)

• Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]

  at baseline, at week 48

• Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]

  at baseline, at week 48

• Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no)

  at baseline, at week 48

• Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels

  at baseline, at week 48

• Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels

  at baseline, at week 48

Study Arms (2)

Treatment arm

EXPERIMENTAL

Combination Product: Survodutide

Placebo arm

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

Survodutide COMBINATION_PRODUCT

Survodutide, pre-filled syringe

Treatment arm

Placebo COMBINATION_PRODUCT

Placebo matching survodutide, pre-filled syringe

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (37)

ARK Clinical Research

Fountain Valley, California, 92708, United States

Location

Velocity Clinical Research-Gardena-69773

Gardena, California, 90247, United States

Location

ARK Clinical Research

Long Beach, California, 92657, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Velocity Clinical Research-North Hollywood-69852

North Hollywood, California, 91606, United States

Location

Velocity Clinical Research-Panorama City-68861

Panorama City, California, 91402, United States

Location

Velocity Clinical Research, Santa Ana

Santa Ana, California, 92704, United States

Location

Excel Medical Clinical Trials

Boca Raton, Florida, 33434, United States

Location

Segal Drug Trials

Delray Beach, Florida, 33484, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida, 33912, United States

Location

Velocity Clinical Research-Hallandale Beach-67888

Hallandale, Florida, 33009, United States

Location

Nature Coast Clinical Research-Inverness-48221

Inverness, Florida, 34452, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Verus Clinical Research Corporation

Miami, Florida, 33135, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Covenant Research and Clinics, LLC

Sarasota, Florida, 34240, United States

Location

Springfield Clinic, LLP

Springfield, Illinois, 62702, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Kansas Medical Clinic PA

Topeka, Kansas, 66606-1707, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

DSI Research Northridge LLC

Dayton, Ohio, 45414, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Velocity Clinical Research, Austin

Austin, Texas, 78759, United States

Location

Amel Med LLC

Georgetown, Texas, 78628, United States

Location

Gastroenterology and Liver Research LLC

Houston, Texas, 77043, United States

Location

Biopharma Informatic, Inc. Research Center

Houston, Texas, 77084, United States

Location

Accurate Clinical Research, Inc.

Humble, Texas, 77346, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Velocity Clinical Research, Waco

Waco, Texas, 76710, United States

Location

GI Select Health Research LLC

Richmond, Virginia, 23236, United States

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• Younossi 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 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 13, 2024
• Study Start: April 2, 2024
• Primary Completion: October 9, 2025
• Study Completion: December 2, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (33); ES (4)