COMBINATION_PRODUCT
Survodutide
Survodutide, pre-filled syringe
Status
Completed
Phase
Phase 3
Enrollment
218
Locations
37
Results
Not posted
Publications
1
Study 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.
Interventions
COMBINATION_PRODUCT
Survodutide, pre-filled syringe
COMBINATION_PRODUCT
Placebo matching survodutide, pre-filled syringe
Timeline
First posted
Mar 13, 2024
Study start
Apr 2, 2024
Primary completion
Oct 9, 2025
Study completion
Dec 2, 2025
Results posted
Not reported
Registry updated
Apr 30, 2026
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
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
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
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
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Recruiting
80
2026-07
Boehringer Ingelheim · Obesity
Phase 3
Completed
5,531
2026-07
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
29
2026-07
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis (MASH) · Liver Fibrosis
Phase 3
Recruiting
1,800
2026-07
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis
Phase 3
Recruiting
1,590
2026-07
Boehringer Ingelheim · Obesity · Diabetes Mellitus, Type 2
Phase 3
Completed
755
2026-06
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Completed
56
2026-06
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
64
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.