A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
VV-14303
Geneticwill be administered via ultrasound guided intramuscular injections
Treatment groups
56 Participants
are divided into 4 treatment groupsGroup A: Part 1 Cohort 1, dose #1Experimental treatment 1 intervention
Group B: Part 1 Cohort 2, dose #2Experimental treatment 1 intervention
Group C: Part 1 Cohort 3, dose #3Experimental treatment 1 intervention
Group D: Part 2 doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
52 Weeks2
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
Time frame
6 weeks3
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
Time frame
26 Weeks4
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
Time frame
26 weeksSecondary outcomes
1
Efficacy associated with VV-14303 in participants with MASH
Liver stiffness as measured by change from Baseline transient elastography as assessed by FibroScan®
Time frame
Week 26 and 522
Efficacy associated with VV-14303 in participants with MASH
Liver stiffness as measured by change from Baseline in Magnetic Resonance Elastography (MRE)
Time frame
Week 26 and 523
Efficacy associated with VV-14303 in participants with MASH
Mean changes in liver fat content as assessed by MRI-PDFF as assessed by FibroScan®
Time frame
52 Weeks4
Efficacy associated with VV-14303 in participants with MASH
Mean changes in liver fat content as assessed by CAP as assessed by FibroScan®
Time frame
52 WeeksSponsors and contacts
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Source ClinicalTrials.gov