ACTIVE_NOT_RECRUITING

RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

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 the treatment of AUD in subjects with obesity or overweight. After signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms: * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly

Official Title

RECLAIM STUDY: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

Quick Facts

Study Start:2025-05-15
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06987513

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. Written informed consent signed prior to performance of any study procedures
  2. 2. Male or female ages 18 to 75 years, inclusive
  3. 3. Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria
  4. 4. Reported drinking at least 28 drinks per week if male or 21 drinks per week if female in the 28 days prior to signing the informed consent. This should include at least 3 heavy drinking days per week (defined as ≥ 5 drinks per day for men and ≥ 4 drinks per day for women) Note: Baseline heavy drinking days will be determined by the TFLB method (28-day recall) drinking pattern collected at the initial screening visit
  5. 5. Overweight or obesity, defined as BMI ≥ 25 kg/m2
  1. 1. Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
  2. 2. History of hospitalization for alcohol intoxication or alcohol withdrawal
  3. 3. History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
  4. 4. History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder or other severe psychiatric disorders, unless documented as well-controlled by the Investigator and cleared by the Medical Monitor
  5. 5. C-SSRS score indicative of active suicidal thoughts (answering "yes" to any of Questions 2 through 5 on the C-SSRS) in the past 6 months

Contacts and Locations

Study Locations (Sites)

Altimmune Clinical Study Site
Los Angeles, California, 90038
United States
Altimmune Clinical Study Site
Aurora, Colorado, 80045
United States
Altimmune Clinical Study Site
New Haven, Connecticut, 06511
United States
Altimmune Clinical Study Site
Fort Myers, Florida, 33912
United States
Altimmune Clinical Study Site
University Park, Florida, 34201
United States
Altimmune Clinical Study Site
North Canton, Ohio, 44720
United States
Altimmune Clinical Study Site
Tulsa, Oklahoma, 74136
United States
Altimmune Clinical Study Site
Philadelphia, Pennsylvania, 19104
United States
Altimmune Clinical Study Site
Providence, Rhode Island, 02923
United States
Altimmune Clinical Study Site
Charleston, South Carolina, 29425
United States
Altimmune Clinical Study Site
Charlottesville, Virginia, 22903
United States
Altimmune Clinical Study Site
Richmond, Virginia, 23298
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 Date2025-05-15
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-05-15
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Pemvidutide
  • GLP-1 receptor agonist
  • Alcohol Use Disorder
  • Obesity
  • Overweight
  • AUD treatment
  • Phase 2

Additional Relevant MeSH Terms

  • Alcohol Use Disorder (AUD)