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Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH

ConditionMetabolic Dysfunction-Associated Steatohepatitis (MASH)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAltimmune, Inc.

About this trial

Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable)

Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2

Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome

Subject agrees to have liver biopsy(ies) as required per protocol

Disqualifiers

Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C

Uncontrolled T2D or clinically significant persistent hyperglycemia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pemvidutide

    Drug

    Pemvidutide SC Injection

  • Placebo

    Other intervention

    Placebo SC Injection

Treatment groups

1,800 Participants
are divided into 3 treatment groups
Group A: Pemvidutide 1.8 mgExperimental treatment 1 intervention
Group B: Pemvidutide 2.4 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Outcome Event

Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause

Time frame
Baseline through end of study (approximately Month 60)
2

Histological Response: MASH resolution

Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis

Time frame
Baseline through Week 52
3

Histological Response: Fibrosis improvement

Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH

Time frame
Baseline through Week 52

Secondary outcomes

1

Histologic Response: Proportion of subjects achieving both MASH resolution (according to NASH CRN classification) without worsening of fibrosis and ≥ 1 stage improvement in liver fibrosis without worsening of MASH

Time frame
Baseline through Week 52
2

HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis

Time frame
Baseline through Week 52
3

Anthropometric parameters: Relative (%) change from baseline in body weight (kg)

Time frame
Baseline through End of Study (approximately Month 60)
4

Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)

Time frame
Baseline through End of Study (approximately Month 60)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Altimmune, Inc.

Lead sponsor

Source ClinicalTrials.gov
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