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
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
1 other identifier
interventional
100
1 country
12
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2025
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2025
CompletedFirst Submitted
Initial submission to the registry
May 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
CompletedJuly 31, 2026
July 1, 2026
1.2 years
May 16, 2025
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the average number of heavy drinking days per week
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 Outcomes (10)
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level
Baseline to Weeks 21-24
Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24
Baseline to Week 24
Change from baseline in average number of drinks per drinking day
Baseline to Weeks 21-24
Change from baseline in proportion of subjects achieving no heavy drinking days
Baseline to Weeks 21-24
Change from baseline in average percent days completely abstinent
Baseline to Weeks 21-24
- +5 more secondary outcomes
Study Arms (2)
Pemvidutide 2.4 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Written informed consent signed prior to performance of any study procedures
- Male or female ages 18 to 75 years, inclusive
- Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria
- 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
- Overweight or obesity, defined as BMI ≥ 25 kg/m2
You may not qualify if:
- Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- History of hospitalization for alcohol intoxication or alcohol withdrawal
- History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altimmune, Inc.lead
Study Sites (12)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2025
First Posted
May 23, 2025
Study Start
May 15, 2025
Primary Completion
July 30, 2026
Study Completion
July 30, 2026
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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.