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

July 30, 2026 updated by: Altimmune, Inc.

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo SC once weekly
Experimental: Pemvidutide 2.4 mg
Drug: Pemvidutide
Pemvidutide 2.4 mg SC once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the average number of heavy drinking days per week
Time Frame: Baseline to Weeks 21-24
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 Timeline Followback (TLFB) method
Baseline to Weeks 21-24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level
Time Frame: Baseline to Weeks 21-24
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
Baseline to Weeks 21-24
Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24
Change from baseline in average number of drinks per drinking day
Time Frame: Baseline to Weeks 21-24
Change from baseline in average number of drinks per drinking day using the TLFB method for the 4-week period comprising Week 21 through 24
Baseline to Weeks 21-24
Change from baseline in proportion of subjects achieving no heavy drinking days
Time Frame: Baseline to Weeks 21-24
Change from baseline in proportion of subjects achieving no heavy drinking days using the TLFB method for the 4-week period comprising Week 21 through 24
Baseline to Weeks 21-24
Change from baseline in average percent days completely abstinent
Time Frame: Baseline to Weeks 21-24
Change from baseline in average percent days completely abstinent using the TLFB method for the 4-week period comprising Week 21 through 24
Baseline to Weeks 21-24
Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change from baseline at Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Negative Alcohol Consequences (NECO) Short Form
Time Frame: Baseline to Week 24
Baseline to Week 24
Percent changes from baseline in body weight
Time Frame: Baseline to Week 24
Baseline to Week 24
Percent change from baseline in BMI
Time Frame: Baseline to Week 24
Baseline to Week 24
Percent change from baseline in waist circumference
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Actual)

July 30, 2026

Study Completion (Actual)

July 30, 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)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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