Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 2:13 AM
Study NCT ID:
NCT07165028
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}, {'id': 'C000729679', 'term': 'retatrutide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)', 'timeFrame': 'Baseline up to Study Completion (about 224 weeks)', 'description': 'Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Enhanced Liver Fibrosis (ELF) Score', 'timeFrame': 'Baseline, Week 104'}, {'measure': 'Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM)', 'timeFrame': 'Baseline, Week 104'}, {'measure': 'Percent Change from Baseline in Liver Fat Content (LFC)', 'timeFrame': 'Baseline, Week 104'}, {'measure': 'Time to Occurrence of Progression to Cirrhosis', 'timeFrame': 'Baseline up to Study Completion (about 224 weeks)'}, {'measure': 'Change from Baseline in Aspartate Aminotransferase (AST)', 'timeFrame': 'Baseline, Study Completion (about 224 weeks)'}, {'measure': 'Change from Baseline in Alanine Aminotransferase (ALT)', 'timeFrame': 'Baseline, Study Completion (about 224 weeks)'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Study Completion (about 224 weeks)'}, {'measure': 'Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK)', 'timeFrame': 'Baseline, Week 104'}, {'measure': 'Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3)', 'timeFrame': 'Baseline up to Study Completion (about 224 weeks)', 'description': 'MACE-3 composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, cardiovascular death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonalcoholic Steatohepatitis', 'NASH', 'Fatty Liver', 'Fatty Liver Disease', 'SLD', 'Metabolic Dysfunction-Associated Fatty Liver Disease', 'MAFLD', 'Non-alcoholic Fatty Liver Disease', 'NAFLD', 'Hepatic Steatosis', 'Liver Related Outcomes', 'GLP1', 'Incretin', 'Non-Invasive Test'], 'conditions': ['Metabolic Dysfunction-Associated Steatotic Liver Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/651596', 'label': 'A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.\n\nOnce the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have liver fat content ≥8%\n* Have ELF score of ≥9 and ≤10.8 at screening\n* Have VCTE LSM ≥10 kilopascal (kPa) and \\<20 kPa at screening\n\nExclusion Criteria:\n\n* Have any other type of liver disease other than MASLD\n* Have a body mass index (BMI) \\<25 kilogram per square meter (kg/m2)\n* Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)\n* Have lost more than 11 pounds within the 3 months prior to screening\n* Have a hemoglobin A1c (HbA1c) greater than 10%\n* Have type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT07165028', 'briefTitle': 'A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes', 'orgStudyIdInfo': {'id': '27610'}, 'secondaryIdInfos': [{'id': '2025-522674-36-00', 'type': 'CTIS'}, {'id': 'N1T-MC-MALO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'N1T-MC-TZ01', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'N1T-MC-RT01', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirzepatide (TZ01)', 'description': 'Participants will receive tirzepatide subcutaneously (SC)', 'interventionNames': ['Drug: Tirzepatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (TZ01)', 'description': 'Participants will receive placebo SC', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Retatrutide (RT01)', 'description': 'Participants will receive retatrutide SC', 'interventionNames': ['Drug: Retatrutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (RT01)', 'description': 'Participants will receive placebo SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide (TZ01)']}, {'name': 'Retatrutide', 'type': 'DRUG', 'otherNames': ['LY3437943'], 'description': 'Administered SC', 'armGroupLabels': ['Retatrutide (RT01)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo (RT01)', 'Placebo (TZ01)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35405', 'city': 'Tuscaloosa', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '205-331-4963'}, {'name': 'Adisesha Reddy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MFA Clinical Research', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yessica Sachdeva', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Institute for Liver Health II dba Arizona Clinical Trials - Chandler', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Donna DeSantis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spectrum Research Institute', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard Manch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Institute for Liver Health II dba Arizona Liver Health - Peoria', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Greatwood', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Epic Medical Research-Sun City', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anita Kohli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Institute for Liver Health II dba Arizona Clinical Trials - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '520-257-3881'}, {'name': 'Bassel Kisso', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Del Sol Research Management, LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samuel Dunn', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arkansas Gastroenterology - North Little Rock', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '91304', 'city': 'Canoga Park', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '818-222-6868'}, {'name': 'Jeffrey London', 'role': 'PRINCIPAL_INVESTIGATOR'}], 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'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 Medical Research - Daytona Beach', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '401-773-7855'}, {'name': 'Sudhir Bansal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Care Access - Delray Beach', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abid Chaudhry', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AMR Clinical', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '239-931-3368'}, {'name': 'Jose Rodriguez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southwest General Healthcare Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-400-1725'}, {'name': 'Rodolfo Perez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encore Medical Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '352-341-2100'}, {'name': 'Paul Hellstern', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nature Coast Clinical Research - Inverness', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '904-680-0871'}, {'name': 'Nikhil Kapila', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encore Borland-Groover Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchell Davis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Health Awareness', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32159', 'city': 'Lady Lake', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '352-500-5252'}, {'name': 'Craig Curtis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 MEDICAL Research THE VILLAGES', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'zip': '34211', 'city': 'Lakewood Rch', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '941-727-7772'}, {'name': 'Manuel Rodriguez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Research Institute', 'geoPoint': {'lat': 27.3863, 'lon': 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