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

Phase 3RecruitingNCT07795164

Altimmune, Inc.1,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,800

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Interventions

PemvidutideDRUG

Pemvidutide SC Injection

PlaceboOTHER

Placebo SC Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: All subjects: * 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 Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing Exclusion Criteria: * 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

Locations (9)

Altimmune Clinical Study Site

North Little Rock, Arkansas, United States

RECRUITING

Altimmune Clinical Study Site

Fountain Valley, California, United States

RECRUITING

Outcomes

Primary Outcomes

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)

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

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

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

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

Time frame: Baseline through Week 52

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

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

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

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

Central Contacts

Shaheen Tomah, MD

CONTACT

240-235-0145 performa@altimmune.com

Data from ClinicalTrials.gov

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