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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Use Disorder (AUD)
• Intervention / Treatment: Other: Placebo; Drug: Pemvidutide

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent signed prior to performance of any study procedures
2. Male or female ages 18 to 75 years, inclusive
3. Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria
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. Overweight or obesity, defined as BMI ≥ 25 kg/m2

Exclusion Criteria:

1. Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
2. History of hospitalization for alcohol intoxication or alcohol withdrawal
3. History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
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. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subcutaneous injection	Other: Placebo; Subcutaneous injection
Experimental: Pemvidutide 2.4mg (Active); Subcutaneous injection	Drug: Pemvidutide; Pemvidutide 2.4mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the average number of heavy drinking days per week, with a heavy drinking day defined as 5 or more drinks in the day for men and 4 or more drinks in the day for women, using the TLFB method	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level using the TLFB method for the 4-week period comprising Weeks 21 through 24.	Week 24
Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24	24 Weeks

Collaborators and Investigators

• Sponsor: Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 16, 2025
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Actual): May 23, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Alcohol Use Disorder; Phase 2; GLP-1 receptor agonist; Pemvidutide; AUD treatment
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Alcoholism
• Other Study ID Numbers: ALT-801-231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is anticipated that the results of this study will be presented at scientific meetings and/or published in a peer reviewed scientific or medical journal. A Publications Committee, comprised of the Investigators participating in the study and representatives from the Sponsor, as appropriate, will be formed to oversee the publication of the study results, which will reflect the experience of all participating study centers. Subsequently, individual Investigators may publish results from the study in compliance with their agreement with the Sponsor.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No