protocolSection identificationModule nctId: NCT06309992, orgStudyIdInfo id: 1404-0056, secondaryIdInfos id: 2023-505303-23-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1299-9925, type: REGISTRY, domain: WHO registry, briefTitle: 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-02-16, completionDateStruct date: 2026-03-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: 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 13 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., conditionsModule conditions: Obesity, conditions: Non-Alcoholic SteatoHepatitis (NASH), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Survodutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: 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), primaryOutcomes measure: Relative change (%) in body weight from baseline to Week 48, secondaryOutcomes measure: Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF, secondaryOutcomes measure: Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF, secondaryOutcomes measure: Reduction from baseline to Week 48 in Iron corrected T1 (cT1) levels of ≥80 ms (yes/no), secondaryOutcomes measure: Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels, secondaryOutcomes measure: Relative change from baseline to Week 48 in alanine amino transferase (ALT) levels, secondaryOutcomes measure: Absolute change from baseline to Week 48 in waist circumference [cm], secondaryOutcomes measure: Relative change from baseline to Week 48 in waist circumference [cm], secondaryOutcomes measure: 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), secondaryOutcomes measure: Absolute change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE), secondaryOutcomes measure: Relative change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE), secondaryOutcomes measure: Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI, secondaryOutcomes measure: Relative change in liver volume [mL] from baseline to Week 48 measured using MRI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Panax Clinical Research, status: RECRUITING, city: Miami Lakes, state: Florida, zip: 33014, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Verus Clinical Research Corporation, status: RECRUITING, city: Miami, state: Florida, zip: 33135, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Louisiana Research Center, LLC, status: RECRUITING, city: Shreveport, state: Louisiana, zip: 71105, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 32.52515, lon: -93.75018, hasResults: False