[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649255":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":73,"collaborators":32,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":32,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":32,"overallStatus":96,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Kriya Therapeutics, Inc.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Cohort 1, dose #1","EXPERIMENTAL","Dose #1 of VV-14303 will be administered",[13],"Genetic: VV-14303",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1 Cohort 2, dose #2","Dose #2 of VV-14303 will be administered",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1 Cohort 3, dose #3","Dose #3 of VV-14303 will be administered",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 2 dose","VV-14303 will be administered at the dose determined from Part 1 (Cohorts 1, 2, and 3)",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"GENETIC","VV-14303","will be administered via ultrasound guided intramuscular injections",[9,15,19,23],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"VP, Medical Affairs","CONTACT","1.984.884.5058","clinicaltrials@kriyatx.com",[40,55,64],{"facility":41,"status":32,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Kriya Clinical Trial Site","Chandler","Arizona","85224","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-111.84125,33.30616,{"lat":51,"lon":50},[54],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"facility":41,"status":32,"city":56,"state":57,"zip":58,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":63,"contacts":32},"Lady Lake","Florida","32159",{"type":48,"coordinates":60},[61,62],-81.92286,28.91749,{"lat":62,"lon":61},{"facility":41,"status":32,"city":65,"state":32,"zip":32,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":32},"Auckland","New Zealand","NZ",{"type":48,"coordinates":69},[70,71],174.76349,-36.84853,{"lat":71,"lon":70},{"type":74,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100649255","phase-1-a-study-of-vv-14303-for-the-treatment-of-metabolic-dysfunction-associated-steatohepatitis-mash-100649255",false,"NCT07732400","A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 1\u002F2, First-in-Human, Multi-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of VV-14303, an Adeno-associated Virus Vector-mediated Fibroblast Growth Factor 21 (FGF21) Gene Therapy, in Adults With Metabolic Dysfunction-associated Steatohepatitis (MASH)","RESTORE","Inclusion Criteria:\n\n* Participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n* Must be 18 to 75 years of age (inclusive) at Screening\n* Body Mass Index (BMI) of 25 to \\\u003C40 kg\u002Fm2 (inclusive)\n* Male participants must agree to use a highly effective contraception during the Treatment Period and at least 12 months after administration of VV-14303. Female participants must not be a woman of child-bearing potential (WOCBP)\n* Biopsy-confirmed MASH\n* Previous history or presence of ≥2 of the following metabolic risk factors: obesity (BMI ≥25 kg\u002Fm²), hypertension (blood pressure \\[BP\\] ≥140\u002F90 mmHg or on antihypertensive medication), dyslipidemia (triglycerides ≥150 mg\u002FdL or high-density lipoprotein cholesterol \\[HDL-C\\] \\\u003C40 mg\u002FdL in men\u002F\\\u003C50 mg\u002FdL in women or on lipid-lowering therapy), type 2 diabetes mellitus\n* Must be willing to refrain from the donation of blood, plasma, platelets, eggs, or sperm during the 12-month post-treatment follow-up period\n\nExclusion Criteria:\n\n* Presence of alternate and\u002For additional liver disease etiologies at Screening, including but not limited to chronic viral hepatitis, autoimmune hepatitis\n* Use of treatments for metabolic syndrome management, including oral antidiabetic drugs (OADs) (e.g., metformin), incretin mimetics (GLP-1 receptor agonists or GLP-1\u002Fgastric inhibitory polypeptide \\[GIP\\] agonists) or other glucose-lowering agents that has not been stable for at least 6 months prior to Screening\n* Use of Resmetirom that has not been stable for at least 6 months prior to Screening visit\n* Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.\n* Type 1 diabetes, or poorly controlled type 2 diabetes (HbA1c \\> 8.0% at Screening)\n* History of major trauma to the muscle(s) intended for IM injection meeting any of the following criteria:\n\n  1. Within 6 months prior to Screening, or\n  2. At any timepoint prior to Screening with continued neurologic or musculoskeletal symptoms\n* Prior participation in any systemic experimental treatment or receiving any other systemic investigational treatment including within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of Screening\n* Any vaccination or planned vaccination 30 days prior to dosing, or planned vaccination 8 weeks post dosing\n* Previously received AAV or adenoviral therapy or participation in any previous gene therapy trial","ALL","18 Years","75 Years",{"count":87,"type":88},56,"ESTIMATED","INTERVENTIONAL",[91,92],"PHASE1","PHASE2","A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)",[95],"Metabolic Dysfunction-associated Steatohepatitis (MASH)","NOT_YET_RECRUITING","2026-07-23",{"date":99,"type":100},"2026-07-28","ACTUAL",{"date":102,"type":88},"2026-07",{"date":104,"type":88},"2029-07",{"name":5,"class":6},3]