Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT07009860

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

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Alcohol-associated Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Altimmune Clinical Study Site, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening
  • Liver stiffness of 10.0-24.9 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 withdrawal within the past year
  • History of seizures related to alcohol within the past year
  • History and/or current 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
  • Attempted suicide and/or serious suicidal intention or plan in the past 10 years

Treatment and study plan

Pemvidutide

Drug

Pemvidutide 2.4 mg SC Injection

Placebo

Other

Placebo SC Injection

Primary outcomes

  1. Relative (%) reduction in liver stiffness by VCTE compared to baseline

    Time frame: Week 48 and 24

Secondary outcomes

  1. Absolute reduction in liver stiffness by vibration controlled transient elastography (VCTE)

    Time frame: Week 48 and 24

  2. Absolute reduction in the Enhanced Liver Fibrosis (ELF) compared to baseline

    Time frame: Week 48 and 24

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2025
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.