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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Pemvidutide 2.4mg
Subcutaneous injection
Altimmune Clinical Study Site
Los Angeles, California, United States
Altimmune Clinical Study Site
Aurora, Colorado, United States
Altimmune Clinical Study Site
New Haven, Connecticut, United States
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
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.
Time frame: Week 24
Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24
Time frame: 24 Weeks
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Altimmune Clinical Study Site
Fort Myers, Florida, United States
Altimmune Clinical Study Site
University Park, Florida, United States
Altimmune Clinical Study Site
North Canton, Ohio, United States
Altimmune Clinical Study Site
Tulsa, Oklahoma, United States
Altimmune Clinical Study Site
Philadelphia, Pennsylvania, United States
Altimmune Clinical Study Site
Providence, Rhode Island, United States
Altimmune Clinical Study Site
Charleston, South Carolina, United States
...and 2 more locations