Could a weekly shot tackle fatty liver and obesity?

NCT ID NCT06309992

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a medicine called survodutide in adults with overweight or obesity and a liver condition called NASH. Participants receive weekly injections of survodutide or a placebo for about a year, along with diet and exercise advice. The goal is to see if the drug reduces liver fat and helps with weight loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Survodutide (injected weekly)
What this could lead to: If successful, survodutide could offer a new treatment option to reduce liver fat and help with weight loss in people with NASH and obesity.
What could go wrong: This is a Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects are possible. Long-term benefits and safety are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

218 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-alcoholic steatohepatitis (NASH) Obesity

Contacts and locations

Locations

ARK Clinical Research

Fountain Valley, California, 92708, United States
ARK Clinical Research

Long Beach, California, 92657, United States
Accurate Clinical Research, Inc.

Humble, Texas, 77346, United States
Amel Med LLC

Georgetown, Texas, 78628, United States
Biopharma Informatic, Inc. Research Center

Houston, Texas, 77084, United States
Catalina Research Institute, LLC

Montclair, California, 91763, United States
Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States
Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida, 33912, United States
Covenant Research and Clinics, LLC

Sarasota, Florida, 34240, United States
DSI Research Northridge LLC

Dayton, Ohio, 45414, United States
Excel Medical Clinical Trials

Boca Raton, Florida, 33434, United States
Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States
GI Select Health Research LLC

Richmond, Virginia, 23236, United States
Gastroenterology and Liver Research LLC

Houston, Texas, 77043, United States
Health Awareness, Inc.

Jupiter, Florida, 33458, United States
Hospital Clínic de Barcelona

Barcelona, 08036, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain
Indiana University

Indianapolis, Indiana, 46202, United States
Kansas Medical Clinic PA

Topeka, Kansas, 66606-1707, United States
Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Nature Coast Clinical Research-Inverness-48221

Inverness, Florida, 34452, United States
Panax Clinical Research

Miami Lakes, Florida, 33014, United States
Segal Drug Trials

Delray Beach, Florida, 33484, United States
Springfield Clinic, LLP

Springfield, Illinois, 62702, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
Velocity Clinical Research, Austin

Austin, Texas, 78759, United States
Velocity Clinical Research, Santa Ana

Santa Ana, California, 92704, United States
Velocity Clinical Research, Waco

Waco, Texas, 76710, United States
Velocity Clinical Research-Gardena-69773

Gardena, California, 90247, United States
Velocity Clinical Research-Hallandale Beach-67888

Hallandale, Florida, 33009, United States
Velocity Clinical Research-North Hollywood-69852

North Hollywood, California, 91606, United States
Velocity Clinical Research-Panorama City-68861

Panorama City, California, 91402, United States
Verus Clinical Research Corporation

Miami, Florida, 33135, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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