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