Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:41 AM
Study NCT ID:
NCT07491458
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Adverse Events (AEs)', 'timeFrame': '26 weeks'}, {'measure': 'Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF', 'timeFrame': '26 weeks'}, {'measure': 'Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF', 'timeFrame': '26 weeks'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC)', 'timeFrame': '26 weeks'}, {'measure': 'Trough Plasma Concentration (Ctrough)', 'timeFrame': '26 weeks'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '26 weeks'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': '26 weeks'}, {'measure': 'Plasma Clearance of drug after extravascular administration (CL/F)', 'timeFrame': '26 weeks'}, {'measure': 'Volume of distribution after extravascular administration (V/F)', 'timeFrame': '26 weeks'}, {'measure': 'Drug elimination half-life (t½)', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MASH - Metabolic Dysfunction-Associated Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.', 'detailedDescription': 'This is a 2-part randomized, double-blind, placebo-controlled, multicenter trial with an open label extension (OLE) to evaluate the safety and exposure of HU6 as well as the effect of HU6 on liver fat and other symptoms associated with MASH.\n\nThe 2-part trial design consists of a blinded intervention period and, for participants who completed the blinded intervention period, an option to continue in an OLE intervention period. The blinded trial design consists of a screening period, a blinded intervention period, an end of treatment (EOT)/early termination (ET) visit, a safety follow-up visit, and two long-term follow up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female ≥30 years of age at time of signing the informed consent.\n* Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH)\n* Women of childbearing potential must not be pregnant or breastfeeding and must use and agree to continue to use a highly effective contraceptive method throughout time on study.\n* Body Mass Index (BMI) ≥27.0 kg/m2 to ≤44 kg/m2\n\nExclusion Criteria:\n\n* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease (eg, Wilson's disease) other than MASH\n* Cholecystectomy or any other surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment.\n* History (including any family history) of malignant hyperthermia.\n* History of malignancy within 5 years (except cutaneous basal or squamous cell carcinoma, carcinoma-in-situ, or low-grade prostate cancer).\n* History of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, hospitalization due to congestive heart failure (CHF), or acute CHF.\n* Significant and unstable lung disease (chronic obstructive pulmonary disease \\[COPD\\], emphysema, pulmonary fibrosis, or asthma) requiring oxygen or chronic daily medication. Note that mild, stable COPD and asthma on inhalers are allowed.\n* Monogenetic diabetes or type 1 diabetes.\n* History of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening.\n* History of agranulocytosis.\n* History of or active evidence of ophthalmological conditions\n* Untreated, uncontrolled, or unstable hypertension\n* Use of any of the following medications/therapies: Vitamin E: use of ursodiol or high-dose vitamin E (\\>400 IU/day) for a duration of \\>1 month within 6 months or started high dose vitamin E for any duration within 3 months prior to screening\n* Within 3 months prior to screening or plan to use prior to coming off study drug: resmetirom (Rezdiffra®), GLP 1 agonists and gastric inhibitory polypeptide (GIP)/GLP-1 agonists, Weight loss medications/therapies including: herbal preparation, over the counter (OTC) drug, mail order or prescription drug, Oral antidiabetic medications/therapies including: insulin, meglitinides, thiazolidinediones. Prescription or OTC stimulants. Recent or current use of obeticholic acid (Ocaliva®), systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines. Warfarin, heparin, factor Xa inhibitors due to risk of bleeding, Medications with high risk of idiosyncratic drug-induced neutropenia (IDIN) or agranulocytosis.\n* History of hepatitis or human immunodeficiency virus (HIV1 \\& HIV2)\n* Intolerance to MRI or with conditions contraindicated for MRI procedures\n* Participation in another clinical trial at the time of screening or exposure to any investigational product, including topical agents, within 28 days prior to starting study treatment\n* Additional inclusion/exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT07491458', 'acronym': 'AMPLIFY', 'briefTitle': 'A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rivus Pharmaceuticals, Inc.'}, 'officialTitle': 'A Parallel Treatment Group, Phase 2a, Double-blind, 4-arm Trial to Evaluate the Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Male and Female Participants Aged 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH)', 'orgStudyIdInfo': {'id': 'RIV-HU6-2204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HU6 450 mg', 'description': '450 mg Once Daily (QD)', 'interventionNames': ['Drug: HU6']}, {'type': 'EXPERIMENTAL', 'label': 'HU6 300 mg', 'description': '300 mg Twice Daily (BID)', 'interventionNames': ['Drug: HU6']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Once Daily', 'description': 'Placebo Once Daily (QD)', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Twice Daily', 'description': 'Placebo Twice Daily (BID)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'HU6', 'type': 'DRUG', 'description': 'HU6 is being evaluated for efficacy in MASH', 'armGroupLabels': ['HU6 300 mg', 'HU6 450 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo Once Daily', 'Placebo Twice Daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Enrique Topete', 'role': 'CONTACT', 'email': 'etopete@azclinicaltrials.com', 'phone': '480-470-4000'}], 'facility': 'Arizona Liver Health - Chandler', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Moore', 'role': 'CONTACT', 'email': 'amoore@azliver.com', 'phone': '480-470-4000'}], 'facility': 'Arizona Liver Health - Peoria', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vivian Martinez', 'role': 'CONTACT', 'email': 'vmartinez@azliver.com', 'phone': '520-485-4000'}], 'facility': 'Arizona Liver Health - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Willis', 'role': 'CONTACT', 'email': 'kmwillis@bhccr.com', 'phone': '501-224-1348'}], 'facility': 'Baptist Health Center for Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samira Moran', 'role': 'CONTACT', 'email': 'smoran@arkclinicalresearch.com', 'phone': '714-988-2021'}], 'facility': 'Ark Clinical Research - Fountain Valley', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92844', 'city': 'Garden Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ryan Dudley', 'role': 'CONTACT', 'email': 'rdudley@nicresearch.com', 'phone': '323-725-0657'}, {'name': 'Michael Dao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institute of Clinical Research', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90815', 'city': 'Long Beach', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samira Moran', 'role': 'CONTACT', 'email': 'smoran@arkclinicalresearch.com', 'phone': '562-997-1000'}], 'facility': 'Ark Clinical Research - Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91763', 'city': 'Montclair', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Gallardo', 'role': 'CONTACT', 'email': 'michael.gallardo@elixiahealth.com', 'phone': '909-590-8409'}, {'name': 'Rizwana Mohseni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catalina Research Institute', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aleesha Browning', 'role': 'CONTACT', 'email': 'abrowning@krcorange.com', 'phone': '657-247-0087'}, {'name': 'Alaa Abousaif, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Knowledge Research Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Valeria Robles', 'role': 'CONTACT', 'email': 'valeria.robles@charterresearch.com', 'phone': '407-337-3000'}], 'facility': 'Charter Research LLC - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60618', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Teresa Kalowsky', 'role': 'CONTACT', 'email': 'Teresa.Kalowsky@charterresearch.com', 'phone': '773-997-1000'}], 'facility': 'Charter Research LLC - Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '71220', 'city': 'Bastrop', 'state': 'Louisiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Casey Petrus', 'role': 'CONTACT', 'email': 'casey.petrus@roviaclinical.com', 'phone': '904-854-1354'}], 'facility': 'Delta Research Partners of Bastrop, LLC', 'geoPoint': {'lat': 32.77828, 'lon': -91.91144}}, {'zip': '71291', 'city': 'West Monroe', 'state': 'Louisiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Davidson', 'role': 'CONTACT', 'email': 'jennifer.davidson@roviaclinical.com', 'phone': '904-854-1354'}], 'facility': 'Delta Research Partners of West Monroe, LLC', 'geoPoint': {'lat': 32.51848, 'lon': -92.14764}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karie Simmons', 'role': 'CONTACT', 'email': 'ksimons@researchmi.com', 'phone': '586-598-3329'}, {'name': 'Ronald Fogel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Institute of Michigan', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Tilley', 'role': 'CONTACT', 'email': 'k.tilley@nucleusnetwork.com', 'phone': '651-641-2900'}, {'name': 'Trish Shamp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nucleus Network Minneapolis', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taleah Brown', 'role': 'CONTACT', 'email': 'tbrown@kcri.health', 'phone': '816-759-5274'}], 'facility': 'Kansas City Research Institute', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63123', 'city': 'St Louis', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristina Wriston', 'role': 'CONTACT', 'email': 'kwriston@kadclinicalresearch.com', 'phone': '314-254-3168'}], 'facility': 'KAD Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Gass', 'role': 'CONTACT', 'email': 'jgass@jcr-lv.com', 'phone': '702-631-5000'}], 'facility': 'Jubilee Clinical Research, LLC.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Maples', 'role': 'CONTACT', 'email': 'jmaples@coastalresearchnc.com', 'phone': '910-500-3146'}], 'facility': 'Coastal Research Institute', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Institute of Ohio, LLC (CRIOH)', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '73099', 'city': 'Yukon', 'state': 'Oklahoma', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Fumero', 'role': 'CONTACT', 'email': 'lfumero@evotrials.com', 'phone': '855-380-2822'}], 'facility': 'Tekton Research - Yukon', 'geoPoint': {'lat': 35.50672, 'lon': -97.76254}}, {'zip': '37040', 'city': 'Clarksville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Kosinski', 'role': 'CONTACT', 'email': 'mkosinski@ICRresearch.com', 'phone': '847-469-6971'}], 'facility': 'Innovative Clinical Research, LLC', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kate Banks', 'role': 'CONTACT', 'email': 'kate.banks@imaresearch.com', 'phone': '512-649-0082'}], 'facility': 'IMA Clinical Research (Austin)', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78757', 'city': 'Austin', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Macias', 'role': 'CONTACT', 'email': 'mmacias@pinnacleresearch.com', 'phone': '512-384-1560'}], 'facility': 'Pinnacle Clinical Research - Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Layla Haider', 'role': 'CONTACT', 'email': 'lhaidar@pinnacleresearch.com', 'phone': '844-399-0449'}], 'facility': 'Bellaire Clinical Research, LLC', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Giron', 'role': 'CONTACT', 'email': 'agiron@pinnacleresearch.com', 'phone': '361-400-5352'}], 'facility': 'Pinnacle Clinical Research - Corpus Christi', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '78626', 'city': 'Georgetown', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nirupama Jerome', 'role': 'CONTACT', 'email': 'njerome@pinnacleresearch.com', 'phone': '737-444-8408'}], 'facility': 'Pinnacle Clinical Research - Georgetown', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Callie Pettigrew', 'role': 'CONTACT', 'email': 'cpettigrew@houstonresearchinstitute.com', 'phone': '713-794-0700'}], 'facility': 'HRI - Medical Center, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Evelyn Gonzalez', 'role': 'CONTACT', 'email': 'egonzalez1@pinnacleresearch.com', 'phone': '281-809-3234'}], 'facility': 'Houston Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77505', 'city': 'Pasadena', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Layla Haidar', 'role': 'CONTACT', 'email': 'lhaidar@pinnacleresearch.com', 'phone': '281-809-3234'}], 'facility': 'HRI - 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Sugarland, LLC', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'centralContacts': [{'name': 'Clinical Operations Lead', 'role': 'CONTACT', 'email': 'jsoto@rivuspharma.com', 'phone': '6173887757'}, {'name': 'VP, Clinical Operations', 'role': 'CONTACT', 'email': 'jdurden@rivuspharma.com', 'phone': '8435683621'}], 'overallOfficials': [{'name': 'Stefanie Mason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rivus Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rivus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}