Trial · Interventional
CompletedPhase 2Registry dataRECLAIM 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
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 100 participants (actual)
- Sponsor
- Altimmune, Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 15 May 2025
- Primary completion
- 30 Jul 2026
- Completion
- 30 Jul 2026
- First posted
- 23 May 2025
- Last update posted
- 31 Jul 2026
- Conditions
- Alcohol Use Disorder (AUD)
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
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
NCT0698751315 May 2025 to 30 Jul 2026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- PemvidutideDrug
- PlaceboOther
Arms2
Experimental
Pemvidutide 2.4 mg
Placebo comparator
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Change from baseline in the average number of heavy drinking days per week
Time frame · Baseline to Weeks 21-24
Registry description
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
Secondary outcomes(10)
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level
Time frame · Baseline to Weeks 21-24
Registry description
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
Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24
Time frame · Baseline to Week 24
Change from baseline in average number of drinks per drinking day
Time frame · Baseline to Weeks 21-24
Registry description
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
Change from baseline in proportion of subjects achieving no heavy drinking days
Time frame · Baseline to Weeks 21-24
Registry description
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
Change from baseline in average percent days completely abstinent
Time frame · Baseline to Weeks 21-24
Registry description
Change from baseline in average percent days completely abstinent using the TLFB method for the 4-week period comprising Week 21 through 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
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
Percent changes from baseline in body weight
Time frame · Baseline to Week 24
Percent change from baseline in BMI
Time frame · Baseline to Week 24
Percent change from baseline in waist circumference
Time frame · Baseline to Week 24
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.