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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemvidutide 2.4mg (Active) | Experimental | Subcutaneous injection |
|
| Placebo | Placebo Comparator | Subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemvidutide | Drug | Pemvidutide 2.4mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 | |
| Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altimmune Clinical Study Site | Los Angeles | California | 90038 | United States | ||
| Altimmune Clinical Study Site |
It is anticipated that the results of this study will be presented at scientific meetings and/or published in a peer reviewed scientific or medical journal. A Publications Committee, comprised of the Investigators participating in the study and representatives from the Sponsor, as appropriate, will be formed to oversee the publication of the study results, which will reflect the experience of all participating study centers. Subsequently, individual Investigators may publish results from the study in compliance with their agreement with the Sponsor.
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| Other |
Subcutaneous injection |
|
| 24 Weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Altimmune Clinical Study Site | New Haven | Connecticut | 06511 | United States |
| Altimmune Clinical Study Site | Fort Myers | Florida | 33912 | United States |
| Altimmune Clinical Study Site | University Park | Florida | 34201 | United States |
| Altimmune Clinical Study Site | North Canton | Ohio | 44720 | United States |
| Altimmune Clinical Study Site | Tulsa | Oklahoma | 74136 | United States |
| Altimmune Clinical Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Altimmune Clinical Study Site | Providence | Rhode Island | 02923 | United States |
| Altimmune Clinical Study Site | Charleston | South Carolina | 29425 | United States |
| Altimmune Clinical Study Site | Charlottesville | Virginia | 22903 | United States |
| Altimmune Clinical Study Site | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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