RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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)

Quick Facts

Study Start:2025-06-16
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07009860

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ages 18 to 75 years, inclusive
  2. 2. Overweight or obesity, defined as BMI ≥ 25 kg/m2
  3. 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. 4. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive
  1. 1. Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
  2. 2. History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year
  3. 3. History of seizures related to alcohol within the past year
  4. 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

Contacts and Locations

Study Contact

Julio Gutierrez, MD
CONTACT
240-654-1450
information@altimmune.com

Study Locations (Sites)

Altimmune Clinical Study Site
Peoria, Arizona, 85381
United States
Altimmune Clinical Study Site
Tucson, Arizona, 85712
United States
Altimmune Clinical Study Site
North Little Rock, Arkansas, 72117
United States
Altimmune Clinical Study Site
Fresno, California, 93720
United States
Altimmune Clinical Study Site
La Jolla, California, 92037
United States
Altimmune Clinical Study Site
Pasadena, California, 91105
United States
Altimmune Clinical Study Site
Englewood, Colorado, 80113
United States
Altimmune Clinical Study Site
Bradenton, Florida, 34201
United States
Altimmune Clinical Study Site
Doral, Florida, 33122
United States
Altimmune Clinical Study Site
Doral, Florida, 33122
United States
Altimmune Clinical Study Site
Fort Myers, Florida, 33192
United States
Altimmune Clinical Study Site
Miami Lakes, Florida, 33122
United States
Altimmune Clinical Study Site
Miami, Florida, 33165
United States
Altimmune Clinical Study Site
Naples, Florida, 34102
United States
Altimmune Clinical Study Site
Orlando, Florida, 32803
United States
Altimmune Clinical Study Site
Port Orange, Florida, 32127
United States
Altimmune Clinical Study Site
Atlanta, Georgia, 30309
United States
Altimmune Clinical Study Site
Indianapolis, Indiana, 46202
United States
Altimmune Clinical Study Site
Louisville, Kentucky, 40202
United States
Altimmune Clinical Study Site
Bastrop, Louisiana, 71220
United States
Altimmune Clinical Study Site
Marrero, Louisiana, 70072
United States
Altimmune Clinical Study Site
Kansas City, Missouri, 64131
United States
Altimmune Clinical Study Site
Las Vegas, Nevada, 89106
United States
Altimmune Clinical Study Site
Manhasset, New York, 11030
United States
Altimmune Clinical Study Site
Westlake, Ohio, 44145
United States
Altimmune Clinical Study Site
Brownsville, Texas, 78520
United States
Altimmune Clinical Study Site
Dallas, Texas, 75390
United States
Altimmune Clinical Study Site
Edinburg, Texas, 78539
United States
Altimmune Clinical Study Site
Houston, Texas, 77030
United States
Altimmune Clinical Study Site
Houston, Texas, 77079
United States
Altimmune Clinical Study Site
San Antonio, Texas, 78215
United States
Altimmune Clinical Study Site
Waco, Texas, 76710
United States
Altimmune Clinical Study Site
Richmond, Virginia, 23249
United States
Altimmune Clinical Study Site
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Altimmune, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2025-06-16
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Liver Disease