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 2.4 mg SC once weekly
Placebo SC once weekly
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
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
Time frame: Baseline to Weeks 21-24
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level
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: Baseline to Weeks 21-24
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
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
Time frame: Baseline to Weeks 21-24
Change from baseline in proportion of subjects achieving no heavy drinking days
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
Time frame: Baseline to Weeks 21-24
Change from baseline in average percent days completely abstinent
Change from baseline in average percent days completely abstinent using the TLFB method for the 4-week period comprising Week 21 through 24
Time frame: Baseline to Weeks 21-24
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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
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