VV-14303 for metabolic liver disease in adults with MASH
Official title: A Phase 1/2, 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)
Run by Kriya Therapeutics, Inc. · NCT07732400 · Data updated 2026-11-12
This study tests VV-14303, a gene therapy, in adults with metabolic dysfunction-associated steatohepatitis (MASH) to see if it is safe and how well it works.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Kriya Therapeutics, Inc. Industry-sponsored |
| Locations | 3 sites (Chandler, Arizona and 2 other locations) |
| Status | Recruiting |
| Started | July 30, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2029 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07732400 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with biopsy-confirmed MASH and at least two metabolic risk factors (obesity, hypertension, dyslipidemia, or type 2 diabetes).
✕Probably not a fit
Participants whose disease does not respond to VV-14303 or who experience adverse effects may not receive a clinical benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1/2, first-in-human, multi-arm, dose-escalation trial evaluating VV-14303, an AAV-delivered FGF21 gene therapy, in adults with MASH. The study aims to characterize safety, tolerability, pharmacokinetics, and potential efficacy. Participants will receive escalating doses to identify a safe and effective range, with monitoring for adverse events and metabolic outcomes. The trial is conducted at select Kriya Therapeutics sites in the U.S. and New Zealand, enrolling adults aged 18-75 with BMI 25-<40 kg/m2 and biopsy-confirmed MASH.
Why it matters
Potential benefit: If successful, participants could experience improvements in liver-related health markers and metabolic risk factors.
How similar studies have gone: Gene therapy approaches for liver metabolic diseases have shown potential in early studies, but this exact VV-14303 approach is investigational and early in development.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 \<40 kg/m2 (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/m²), hypertension (blood pressure \[BP\] ≥140/90 mmHg or on antihypertensive medication), dyslipidemia (triglycerides ≥150 mg/dL or high-density lipoprotein cholesterol \[HDL-C\] \<40 mg/dL in men/\<50 mg/dL 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 Exclusion Criteria: * Presence of alternate and/or 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/gastric 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: 1. Within 6 months prior to Screening, or 2. At any timepoint prior to Screening with continued neurologic or musculoskeletal symptoms * 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
Where it's running
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Kriya Clinical Trial Site
Lady Lake, Florida, United States Recruiting -
Kriya Clinical Trial Site
Chandler, Arizona, United States Not yet recruiting -
Kriya Clinical Trial Site
Auckland, New Zealand Not yet recruiting
Study contacts
- Study coordinator: VP, Medical Affairs
- Email: clinicaltrials@kriyatx.com
- Phone: 1.984.884.5058
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.