RECRUITING

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

Description

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

Conditions

Alcohol Liver Disease
Talk to us

Related Conditions:

Alcohol Liver Disease

Study Overview

On this page

Study Details

Study 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

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)

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

Condition
Alcohol Liver Disease
Intervention / Treatment

-

Contacts and Locations

Peoria

Altimmune Clinical Study Site, Peoria, Arizona, United States, 85381

Tucson

Altimmune Clinical Study Site, Tucson, Arizona, United States, 85712

North Little Rock

Altimmune Clinical Study Site, North Little Rock, Arkansas, United States, 72117

Fresno

Altimmune Clinical Study Site, Fresno, California, United States, 93720

La Jolla

Altimmune Clinical Study Site, La Jolla, California, United States, 92037

Pasadena

Altimmune Clinical Study Site, Pasadena, California, United States, 91105

Englewood

Altimmune Clinical Study Site, Englewood, Colorado, United States, 80113

Bradenton

Altimmune Clinical Study Site, Bradenton, Florida, United States, 34201

Doral

Altimmune Clinical Study Site, Doral, Florida, United States, 33122

Doral

Altimmune Clinical Study Site, Doral, Florida, United States, 33122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female ages 18 to 75 years, inclusive
  • 2. Overweight or obesity, defined as BMI ≥ 25 kg/m2
  • 3. 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
  • 4. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive
  • 1. Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
  • 2. History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year
  • 3. History of seizures related to alcohol within the past year
  • 4. 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Altimmune, Inc.,

Study Record Dates

2027-08-31