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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/m2. 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.

Study design
This is a Phase 1/2 study, which means it's an early-stage study to test safety and initial effectiveness. It plans to enroll 56 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
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.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07732400

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

Not Yet Recruiting
PHASE1Ages 18–75InterventionalTreatment
Kriya Therapeutics, Inc.
~56 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:VV-14303

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, abnormal vital signs, abnormal ECGs, and abnormal imaging
Measured over 52 Weeks
+3 more outcomes measured

Conditions

Metabolic Dysfunction-associated Steatohepatitis (MASH)

Explore related trials

DyslipidemiaHypertensionNonalcoholic SteatohepatitisObesityType 2 Diabetes Mellitus

Where it's being run

3 sites across 3 states
Arizona1
Florida1
New Zealand1

Who to contact

VP, Medical Affairs
[email protected]
1.984.884.5058
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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

What this trial measures

  • Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical exams, abnormal vital signs, abnormal ECGs, and abnormal imaging52 Weeks

    Safety of VV-14303 in participants with MASH

  • Number of participants with improvement in overall metabolic health, as assessed by changes in serum biomarker levels6 weeks

    Evaluate safety and efficacy of VV-14303 in participants with MASH in Part 1

  • Changes in liver fat content as assessed by Magnetic Resonance Proton Density Fat Fraction (MRI-PDFF) as assessed by FibroScan®26 Weeks

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

  • Change in liver fat content as assessed by controlled attenuation parameter (CAP) as assessed by FibroScan®26 weeks

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