A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)

NCT07732400 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KRIYA-497-101
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 3

Brief Summary

A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)

Conditions

Metabolic Dysfunction-associated Steatohepatitis (MASH)

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Change in liver fat content as assessed by controlled attenuation parameter (CAP) as assessed by FibroScan®

  Efficacy of VV-14303 in participants with MASH in Part 2

  26 weeks

Secondary Outcomes (7)

• Efficacy associated with VV-14303 in participants with MASH

  Week 26 and 52

• Efficacy associated with VV-14303 in participants with MASH

  Week 26 and 52

• Efficacy associated with VV-14303 in participants with MASH

  52 Weeks

• Efficacy associated with VV-14303 in participants with MASH

  52 Weeks

• Part 1: Efficacy associated with VV-14303 in participants with MASH

  26 Weeks

Study Arms (4)

Part 1 Cohort 1, dose #1

EXPERIMENTAL

Dose #1 of VV-14303 will be administered

Genetic: VV-14303

Part 1 Cohort 2, dose #2

EXPERIMENTAL

Dose #2 of VV-14303 will be administered

Genetic: VV-14303

Part 1 Cohort 3, dose #3

EXPERIMENTAL

Dose #3 of VV-14303 will be administered

Genetic: VV-14303

Part 2 dose

EXPERIMENTAL

VV-14303 will be administered at the dose determined from Part 1 (Cohorts 1, 2, and 3)

Genetic: VV-14303

Interventions

VV-14303 GENETIC

will be administered via ultrasound guided intramuscular injections

Part 1 Cohort 1, dose #1; Part 1 Cohort 2, dose #2; Part 1 Cohort 3, dose #3; Part 2 dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Within 6 months prior to Screening, or
• 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

Sponsors & Collaborators

• Kriya Therapeutics, Inc.: lead

Study Sites (3)

Kriya Clinical Trial Site

Chandler, Arizona, 85224, United States

Location

Kriya Clinical Trial Site

Lady Lake, Florida, 32159, United States

Location

Kriya Clinical Trial Site

Auckland, New Zealand

Location

Central Study Contacts

VP, Medical Affairs

CONTACT

1.984.884.5058; clinicaltrials@kriyatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 28, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (2); NZ (1)