A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKriya Therapeutics, Inc.
About this trial
A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- VV-14303
Treatment groups
56 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov