Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pemvidutide · 4 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Pemvidutide 2.4 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Pemvidutide 2.4mg (Active) | EXPERIMENTAL | Subcutaneous injection |
| Pemvidutide 1.2 mg | EXPERIMENTAL | - |
| Pemvidutide 1.8 mg | EXPERIMENTAL | - |
| Part 1 Metformin and Atorvastatin with and without Pemvidutide | EXPERIMENTAL | In Period 1, subjects received metformin 500 mg BID on Days 1 and 2, single doses of metformin 500 mg and atorvastatin 40 mg on Day 3, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, metformin 500 mg BID on Days 34 and 35, and pemvidutide 1.8 mg on Day 36 immediately followed by oral metformin 500 mg and atorvastatin 40 mg. |
| Part 2 Warfarin and Digoxin with and without Pemvidutide | EXPERIMENTAL | In Period 1, subjects received single doses of warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 1, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, and pemvidutide1.8 mg immediately followed by warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 36. |
| Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide | EXPERIMENTAL | In Period 1, subjects received a combined oral contraceptive (COC) consisting of 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel once daily on Days 1 through 9 and a single dose of pemvidutide 0.6 mg on Day 15. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 22 and 1.8 mg on Days 29 and 36. Subjects also received COC once daily on Days 35 through 42 and a single dose of pemvidutide 1.8 mg followed immediately by a single dose of COC on Day 43. |
| Name | Type | Description |
|---|---|---|
| Pemvidutide | DRUG | Pemvidutide 2.4 mg |
| Placebo | OTHER | Subcutaneous injection |
| Metformin | DRUG | Taken by mouth (PO) |
| Atorvastatin | DRUG | Taken by mouth (PO) |
| Warfarin | DRUG | Taken by mouth (PO) |
| Digoxin | DRUG | Taken by mouth (PO) |
| Ethinylestradiol and Levonorgestrel | DRUG | Taken by mouth (PO) |
Inclusion Criteria: 1. Male or female ages 18 to 75 years, inclusive 2. Overweight or obesity, defined as BMI ≥ 25 kg/m2 3. History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year 4. Liver st...