protocolSection identificationModule nctId: NCT06342947, orgStudyIdInfo id: ALG-055009-303, briefTitle: ALG-055009 in Non-cirrhotic Adults With MASH (HERALD), acronym: HERALD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2024-12-23, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Aligos Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks., conditionsModule conditions: NASH, conditions: MASH, conditions: Metabolic Dysfunction-Associated Steatohepatitis, conditions: Nonalcoholic Steatohepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: ALG-055009, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent relative change from baseline in liver fat content, secondaryOutcomes measure: Absolute change from baseline in liver fat content, secondaryOutcomes measure: Proportion of subjects with ≥30% relative reduction in liver fat content, secondaryOutcomes measure: Proportion of subjects with ≥50% relative reduction in liver fat content, secondaryOutcomes measure: Proportion of subjects with ≥70% relative reduction in liver fat content, secondaryOutcomes measure: Proportion of subjects with normalization (<5%) in liver fat content, otherOutcomes measure: Change from baseline (absolute/percent) in lipid/lipoprotein levels, otherOutcomes measure: Change from baseline (absolute/percent) in SHBG, otherOutcomes measure: Change from baseline (absolute/percent) alanine aminotransferase (ALT), otherOutcomes measure: Change from baseline (absolute/percent) aspartate aminotransferase (AST), otherOutcomes measure: Safety and tolerability will be assessed by monitoring TEAEs, otherOutcomes measure: Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs), otherOutcomes measure: PK parameters of ALG-055009 in plasma, AUCs, otherOutcomes measure: PK parameters of ALG-055009 in plasma, Tmax, otherOutcomes measure: PK parameters of ALG-055009 in plasma, Cmax, otherOutcomes measure: PK parameters of ALG-055009 in plasma, Cmin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aligos Clinical Study Site 18, status: RECRUITING, city: Chandler, state: Arizona, zip: 85224, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 33.30616, lon: -111.84125, locations facility: Aligos Clinical Study Site 15, status: RECRUITING, city: Peoria, state: Arizona, zip: 85301, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 33.5806, lon: -112.23738, locations facility: Aligos Clinical Study Site 17, status: RECRUITING, city: Tucson, state: Arizona, zip: 85641, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Aligos Clinical Study Site 35, status: RECRUITING, city: Chula Vista, state: California, zip: 91902, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.64005, lon: -117.0842, locations facility: Aligos Clinical Study Site 1, status: RECRUITING, city: Lincoln, state: California, zip: 95648, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 38.89156, lon: -121.29301, locations facility: Aligos Clinical Study Site 37, status: RECRUITING, city: Poway, state: California, zip: 92025, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.96282, lon: -117.03586, locations facility: Aligos Clinical Study Site 10, status: RECRUITING, city: Rialto, state: California, zip: 92316, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 34.1064, lon: -117.37032, locations facility: Aligos Clinical Study Site 26, status: RECRUITING, city: Bradenton, state: Florida, zip: 34205, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Aligos Clinical Study Site 25, status: RECRUITING, city: Clearwater, state: Florida, zip: 33755, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 27.96585, lon: -82.8001, locations facility: Aligos Clinical Study Site 39, status: RECRUITING, city: Fort Myers, state: Florida, zip: 33901, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 26.62168, lon: -81.84059, locations facility: Aligos Clinical Study Site 2, status: RECRUITING, city: Maitland, state: Florida, zip: 32751, 32794, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Aligos Clinical Study Site 22, status: RECRUITING, city: Ocoee, state: Florida, zip: 32703, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.56917, lon: -81.54396, locations facility: Aligos Clinical Study Site 32, status: RECRUITING, city: Port Orange, state: Florida, zip: 32119, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.13832, lon: -80.99561, locations facility: Aligos Clinical Study Site 38, status: RECRUITING, city: Sarasota, state: Florida, zip: 34230, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 27.33643, lon: -82.53065, locations facility: Aligos Clinical Study Site 31, status: RECRUITING, city: The Villages, state: Florida, zip: 32159, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.93408, lon: -81.95994, locations facility: Aligos Clinical Study Site 3, status: RECRUITING, city: Viera, state: Florida, zip: 32924, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.24696, lon: -80.737, locations facility: Aligos Clinical Study Site 30, status: RECRUITING, city: Winter Park, state: Florida, zip: 32789, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 28.6, lon: -81.33924, locations facility: Aligos Clinical Study Site 23, status: RECRUITING, city: Athens, state: Georgia, zip: 30601, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 33.96095, lon: -83.37794, locations facility: Aligos Clinical Study Site 12, status: RECRUITING, city: Topeka, state: Kansas, zip: 66546, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Aligos Clinical Study Site 29, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40018, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Aligos Clinical Study Site 24, status: RECRUITING, city: Bastrop, state: Louisiana, zip: 71220, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.75625, lon: -91.87235, locations facility: Aligos Clinical Study Site 5, status: RECRUITING, city: Houma, state: Louisiana, zip: 70360, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.59577, lon: -90.71953, locations facility: Aligos Clinical Study Site 4, status: RECRUITING, city: Marrero, state: Louisiana, zip: 70072, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.89937, lon: -90.10035, locations facility: Aligos Clinical Study Site 6, status: RECRUITING, city: Metairie, state: Louisiana, zip: 70001, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Aligos Clinical Study Site 14, status: RECRUITING, city: Chesterfield, state: Michigan, zip: 48047, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 42.66281, lon: -82.84242, locations facility: Aligos Clinical Study Site 7, status: RECRUITING, city: New York, state: New York, zip: 10001, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Aligos Clinical Study Site 8, status: RECRUITING, city: Morehead City, state: North Carolina, zip: 28557, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 34.72294, lon: -76.72604, locations facility: Aligos Clinical Study Site 21, status: RECRUITING, city: Columbus, state: Ohio, zip: 43004, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Aligos Clinical Study Site 16, status: RECRUITING, city: Westlake, state: Ohio, zip: 44145, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 41.45532, lon: -81.91792, locations facility: Aligos Clinical Study Site 36, status: RECRUITING, city: East Greenwich, state: Rhode Island, zip: 02818, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 41.66038, lon: -71.45589, locations facility: Aligos Clinical Study Site 9, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37011, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Aligos Clinical Study Site 19, status: RECRUITING, city: Austin, state: Texas, zip: 73301, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Aligos Clinical Study Site 33, status: RECRUITING, city: Bellaire, state: Texas, zip: 77401, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.70579, lon: -95.45883, locations facility: Aligos Clinical Study Site 27, status: RECRUITING, city: Brownsville, state: Texas, zip: 78520, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 25.90175, lon: -97.49748, locations facility: Aligos Clinical Study Site 28, status: RECRUITING, city: Edinburg, state: Texas, zip: 78504, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 26.30174, lon: -98.16334, locations facility: Aligos Clinical Study Site 40, status: RECRUITING, city: Farmers Branch, state: Texas, zip: 75006, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 32.92651, lon: -96.89612, locations facility: Aligos Clinical Study Site 20, status: RECRUITING, city: San Antonio, state: Texas, zip: 78015, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Aligos Clinical Study Site 11, status: RECRUITING, city: Waco, state: Texas, zip: 76633, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 31.54933, lon: -97.14667, locations facility: Aligos Clinical Study Site 13, status: RECRUITING, city: Manassas, state: Virginia, zip: 20108, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 38.75095, lon: -77.47527, locations facility: Aligos Clinical Study Site 34, status: RECRUITING, city: Seattle, state: Washington, zip: 98039, country: United States, contacts name: Central contact, role: CONTACT, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False