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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Altimmune, Inc.
Study ID
NCT06987513
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pemvidutide — DRUG
    Pemvidutide 2.4mg
  • Placebo — OTHER
    Subcutaneous injection

Study Details

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

Key Dates

Start date
May 15, 2025
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pemvidutide 2.4mg (Active)
    Subcutaneous injection
  • Placebo Comparator: Placebo
    Subcutaneous injection

Primary Outcome Measure

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 [ Time Frame: Week 24 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Altimmune Clinical Study SiteLos AngelesCalifornia90038-
Altimmune Clinical Study SiteAuroraColorado80045-
Altimmune Clinical Study SiteNew HavenConnecticut06511-
Altimmune Clinical Study SiteFort MyersFlorida33912-
Altimmune Clinical Study SiteUniversity ParkFlorida34201-
Altimmune Clinical Study SiteNorth CantonOhio44720-
Altimmune Clinical Study SiteTulsaOklahoma74136-
Altimmune Clinical Study SitePhiladelphiaPennsylvania19104-
Altimmune Clinical Study SiteProvidenceRhode Island02923-
Altimmune Clinical Study SiteCharlestonSouth Carolina29425-
Altimmune Clinical Study SiteCharlottesvilleVirginia22903-
Altimmune Clinical Study SiteRichmondVirginia23298-

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