Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-28 @ 6:56 AM
Study NCT ID:
NCT06309992
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}}, '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) [%]', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change (%) in body weight [kg] from baseline to Week 48', 'timeFrame': 'at baseline, at week 48'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no)', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Absolute change from baseline to Week 48 in waist circumference [cm]', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change from baseline to Week 48 in waist circumference [cm]', 'timeFrame': 'at baseline, at week 48'}, {'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)', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change from baseline to Week 48 in HOMA-IR (FPI [mlU/L] · FPG [mmol/L]/22.5)', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Absolute change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI', 'timeFrame': 'at baseline, at week 48'}, {'measure': 'Relative change in liver volume [mL] from baseline to Week 48 measured using MRI', 'timeFrame': 'at baseline, at week 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Non-Alcoholic SteatoHepatitis (NASH)']}, 'referencesModule': {'references': [{'pmid': '39967239', 'type': 'DERIVED', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to adults who are at least 18 years old and have\n\n* presumed or confirmed NASH together with overweight or obesity and\n* a body mass index (BMI) of 30 kg/m² or more, or\n* a BMI of 27 kg/m² and at least one weight-related health problem.\n\nPeople with a history of other chronic liver diseases cannot take part in this study.\n\nThe 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key inclusion criteria:\n\n* 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\n* BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-related comorbidities at screening:\n\n * 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)\n * 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\n * Obstructive sleep apnoea\n * 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)\n * 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)\n* History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.\n\nKey exclusion criteria:\n\n* 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.\n* Intake of medications associated with liver injury, hepatic steatosis or steatohepatitis.\n* 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.\n* 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.\n* Current decompensated liver disease or previous hepatic decompensation (ascites, spontaneous bacterial peritonitis, portal hypertension bleeding, hepatic encephalopathy, hepatorenal syndrome).\n* Evidence of portal hypertension (e.g. splenomegaly, oesophageal varices, or other portosystemic collateral pathways).\n\nFurther exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06309992', '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Multicentre, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)', 'orgStudyIdInfo': {'id': '1404-0056'}, 'secondaryIdInfos': [{'id': '2023-505303-23-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1299-9925', 'type': 'REGISTRY', 'domain': 'WHO registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'interventionNames': ['Drug: Survodutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Survodutide', 'type': 'DRUG', 'description': 'Survodutide', 'armGroupLabels': ['Treatment arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching survodutide', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'ARK Clinical Research', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90247', 'city': 'Gardena', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research-Gardena-69773', 'geoPoint': {'lat': 33.88835, 'lon': -118.30896}}, {'zip': '92657', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'ARK Clinical Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC - Montclair', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '91606', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research-North Hollywood-69852', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research-Panorama City-68861', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research, Santa Ana', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Drug Trials', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Fleming Island Center for Clinical Research', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Covenant Metabolic Specialists, LLC - Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'Velocity Clinical Research-Hallandale Beach-67888', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research-Inverness-48221', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Verus Clinical Research Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Panax Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34240', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Covenant Research and Clinics, LLC', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Clinic, LLP', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Medical Clinic PA', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Research Center, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'DSI Research Northridge LLC', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research, Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78628', 'city': 'Georgetown', 'state': 'Texas', 'country': 'United States', 'facility': 'Amel Med LLC', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Gastroenterology and Liver Research LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77084', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Biopharma Informatic, Inc. Research Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77346', 'city': 'Humble', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research, Inc.', 'geoPoint': {'lat': 29.99883, 'lon': -95.26216}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76710', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research, Waco', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '23236', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'GI Select Health Research LLC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Vall D Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon Y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nFurthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}