[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732400":3,"trial-entities:NCT07732400":132,"trial-summary:NCT07732400":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":54,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":95,"locations":98,"central_contacts":127,"overall_officials":129,"references":130,"see_also_links":131},"NCT07732400","KRIYA-497-101","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)","NOT_YET_RECRUITING","2029-07","2026-07","2026-07-28","Kriya Therapeutics, Inc.","INDUSTRY",true,"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, 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) (the RESTORE Study)",[18],"Metabolic Dysfunction-associated Steatohepatitis (MASH)",[],"INTERVENTIONAL","TREATMENT",[23,24],"PHASE1","PHASE2",{"count":26,"type":27},56,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"GENETIC","VV-14303","will be administered via ultrasound guided intramuscular injections",[34,35,36,37],"Part 1 Cohort 1, dose #1","Part 1 Cohort 2, dose #2","Part 1 Cohort 3, dose #3","Part 2 dose",[39,43,47,51],{"measure":40,"description":41,"timeFrame":42},"Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, abnormal vital signs, abnormal ECGs, and abnormal imaging","Safety of VV-14303 in participants with MASH","52 Weeks",{"measure":44,"description":45,"timeFrame":46},"Number of participants with improvement in overall metabolic health, as assessed by changes in serum biomarker levels","Evaluate safety and efficacy of VV-14303 in participants with MASH in Part 1","6 weeks",{"measure":48,"description":49,"timeFrame":50},"Changes in liver fat content as assessed by Magnetic Resonance Proton Density Fat Fraction (MRI-PDFF) as assessed by FibroScan®","Efficacy of VV-14303 in participants with MASH in Part 2","26 Weeks",{"measure":52,"description":49,"timeFrame":53},"Change in liver fat content as assessed by controlled attenuation parameter (CAP) as assessed by FibroScan®","26 weeks",[55,59,61,63,65,67,68],{"measure":56,"description":57,"timeFrame":58},"Efficacy associated with VV-14303 in participants with MASH","Liver stiffness as measured by change from Baseline transient elastography as assessed by FibroScan®","Week 26 and 52",{"measure":56,"description":60,"timeFrame":58},"Liver stiffness as measured by change from Baseline in Magnetic Resonance Elastography (MRE)",{"measure":56,"description":62,"timeFrame":42},"Mean changes in liver fat content as assessed by MRI-PDFF as assessed by FibroScan®",{"measure":56,"description":64,"timeFrame":42},"Mean changes in liver fat content as assessed by CAP as assessed by FibroScan®",{"measure":66,"description":62,"timeFrame":50},"Part 1: Efficacy associated with VV-14303 in participants with MASH",{"measure":66,"description":64,"timeFrame":50},{"measure":69,"description":70,"timeFrame":42},"Concentration of adeno-associated virus (AAV) vector-mediated transgene product in serum","Pharmacokinetics of VV-14303 transgene product","ALL","18 Years","75 Years",false,{"inclusion":76,"exclusion":84,"raw_text":94},[77,78,79,80,81,82,83],"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","Must be 18 to 75 years of age (inclusive) at Screening","Body Mass Index (BMI) of 25 to \\\u003C40 kg\u002Fm2 (inclusive)","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)","Biopsy-confirmed MASH","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","Must be willing to refrain from the donation of blood, plasma, platelets, eggs, or sperm during the 12-month post-treatment follow-up period",[85,86,87,88,89,90,91,92,93],"Presence of alternate and\u002For additional liver disease etiologies at Screening, including but not limited to chronic viral hepatitis, autoimmune hepatitis","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","Use of Resmetirom that has not been stable for at least 6 months prior to Screening visit","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.","Type 1 diabetes, or poorly controlled type 2 diabetes (HbA1c \\> 8.0% at Screening)","History of major trauma to the muscle(s) intended for IM injection meeting any of the following criteria:","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","Any vaccination or planned vaccination 30 days prior to dosing, or planned vaccination 8 weeks post dosing","Previously received AAV or adenoviral therapy or participation in any previous gene therapy trial","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",[96,97],"ADULT","OLDER_ADULT",[99,114,121],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":111},"Kriya Clinical Trial Site","Chandler","Arizona","85224","United States",[106],{"name":107,"role":108,"phone":109,"email":110},"VP, Medical Affairs","CONTACT","1.984.884.5058","clinicaltrials@kriyatx.com",{"lat":112,"lon":113},33.30616,-111.84125,{"facility":100,"city":115,"state":116,"zip":117,"country":104,"geoPoint":118},"Lady Lake","Florida","32159",{"lat":119,"lon":120},28.91749,-81.92286,{"facility":100,"city":122,"country":123,"geoPoint":124},"Auckland","New Zealand",{"lat":125,"lon":126},-36.84853,174.76349,[128],{"name":107,"role":108,"phone":109,"email":110},[],[],[],{"nct_id":4,"conditions":133,"biomarkers":139},[134,135,136,137,138],"Dyslipidemia","Hypertension","Nonalcoholic Steatohepatitis","Obesity","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":14,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is a Phase 1\u002F2 study, which means it's an early-stage study to test safety and initial effectiveness. It plans to enroll 56 participants.","completed","A Study of VV-14303 for MASH","This study is testing a new treatment called VV-14303 for Metabolic Dysfunction-associated Steatohepatitis (MASH), a liver condition. VV-14303 is a gene therapy given through injections into the muscle, guided by ultrasound. We are looking for adults aged 18 to 75 with MASH and a BMI between 25 and under 40 kg\u002Fm2. The study aims to see how safe VV-14303 is and if it can improve overall metabolic health and reduce liver fat. We will measure safety over 52 weeks, metabolic health changes after 6 weeks, and liver fat changes after 26 weeks. The current status of this study is unclear, but it plans to enroll 56 participants.","Participants will be followed for safety for 52 weeks. Changes in metabolic health will be assessed at 6 weeks, and liver fat content at 26 weeks.",107,"Not specified in the trial record.","Not stated in the trial record.",[31],null]