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Recruiting NCT07009860

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

Phase II Interventional Alcohol Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pemvidutide, Placebo.
Who it may be relevant to
Registry conditions: Alcohol Liver Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

Overview

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD. * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly

Interventions

  • Drug Pemvidutide
    Pemvidutide 2.4 mg
  • Other Placebo
    Subcutaneous injection

Primary outcome measures

  • Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24 [Time frame: Week 24]
Secondary outcome measures (2)
  • Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48 [Time frame: Week 24 and 48]
  • Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline [Time frame: Week 24 and 48]

Eligibility criteria

Inclusion criteria

  • Male or female ages 18 to 75 years, inclusive
  • Overweight or obesity, defined as BMI ≥ 25 kg/m2
  • History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year
  • Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive

Exclusion criteria

  • Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
  • History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year
  • History of seizures related to alcohol within the past year
  • History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 42 centers
  • Altimmune Clinical Study Site — Peoria
  • Altimmune Clinical Study Site — Tucson
  • Altimmune Clinical Study Site — Tuscon
  • Altimmune Clinical Study Site — North Little Rock
  • Altimmune Clinical Study Site — Fresno
  • Altimmune Clinical Study Site — La Jolla
  • Altimmune Clinical Study Site — Pasadena
  • Altimmune Clinical Study Site — Englewood
  • … and 34 more centers
Puerto Rico · 1 center
  • Altimmune Clinical Study Site — San Juan

Identifiers

NCT: NCT07009860 · ALT-801-241

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗