AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllKriya Therapeutics, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ2 of the following metabolic risk factors: obesity (BMI โ‰ฅ25 kg/mยฒ), hypertension (blood pressure \[BP\] โ‰ฅ140/90 mmHg or on antihypertensive medication), dyslipidemia (triglycerides โ‰ฅ150 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
๐Ÿ’Š

What it tests

  • VV-14303
๐Ÿ“

Where

3 sites
Kriya Clinical Trial Site
Chandler, United States
Kriya Clinical Trial Site
Lady Lake, United States
Kriya Clinical Trial Site
Auckland, New Zealand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy