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

NCT ID: NCT06309992

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2025-12-02

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment arm

Group Type: EXPERIMENTAL

Survodutide

Intervention Type: DRUG

Survodutide

Placebo arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching survodutide

Interventions

Survodutide

Survodutide

Intervention Type: DRUG

Placebo

Placebo matching survodutide

Intervention Type: DRUG

Eligibility Criteria

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)

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

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

Medical University of South Carolina

Charleston, South Carolina, United States

Velocity Clinical Research, Austin

Austin, Texas, United States

Amel Med LLC

Georgetown, Texas, United States

Gastroenterology and Liver Research LLC

Houston, Texas, United States

Biopharma Informatic, Inc. Research Center

Houston, Texas, United States

Accurate Clinical Research, Inc.

Humble, Texas, United States

Clinical Trials of Texas, LLC

San Antonio, Texas, United States

Velocity Clinical Research, Waco

Waco, Texas, United States

GI Select Health Research LLC

Richmond, Virginia, United States

Hospital Universitari Vall D Hebron

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Countries

United States; Spain

References

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.

Reference Type: DERIVED

PMID: 39967239 (View on PubMed)

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2023-505303-23-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1299-9925

Identifier Type: REGISTRY

Identifier Source: secondary_id

1404-0056

Identifier Type: -

Identifier Source: org_study_id