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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Altimmune, Inc.
Study ID
NCT06987513
Phase
PHASE2
Status
Completed

Conditions

  • Alcohol Use Disorder (AUD)

Eligibility Criteria

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

Interventions

  • Pemvidutide — DRUG
    Pemvidutide 2.4 mg SC once weekly
  • Placebo — OTHER
    Placebo SC once weekly

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

First listed
May 23, 2025
Start date
May 15, 2025
Status verified
Jul 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

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

Arms

  • Experimental: Pemvidutide 2.4 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in the average number of heavy drinking days per week [ Time Frame: Baseline to Weeks 21-24 ]

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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