Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pemvidutide · 5 trials · 5 indications
Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH
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
| Arm | Type | Description |
|---|---|---|
| Pemvidutide 1.8 mg | EXPERIMENTAL | - |
| Pemvidutide 2.4 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Pemvidutide 1.2 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 SC Injection |
| Placebo | OTHER | Placebo SC 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: All subjects: * No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable) * Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2 * Type 2 di...
Pemvidutide is an investigational peptide being developed for Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), Alcohol-associated Liver Disease, and Nonalcoholic Steatohepatitis (NASH). It is currently in Phase 2 and Phase 3 clinical trials for these conditions.
Pemvidutide targets the GLP-1 and glucagon receptors (GLP-1/GCGR). It is a peptide that acts as an agonist at these receptors, which are involved in metabolic regulation. This dual targeting is being studied for its potential effects in MASH, NASH, and alcohol-related conditions.
Pemvidutide is being developed by Altimmune, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple indications.
Pemvidutide is in Phase 2 and Phase 3 clinical development. It has a Phase 3 trial recruiting for MASH, and Phase 2 trials for alcohol-associated liver disease and alcohol use disorder. It is not FDA approved and remains investigational.
Pemvidutide is being studied in several trials: NCT07795164 (Phase 3, MASH, recruiting), NCT07009860 (Phase 2, alcohol-associated liver disease, active), NCT06987513 (Phase 2, AUD, completed), and NCT05989711 (Phase 2, NASH, completed). These trials are primarily in the United States.
Pemvidutide is a distinct investigational drug with no alternative names provided. It is a peptide targeting GLP-1 and glucagon receptors, and it is being developed specifically by Altimmune for metabolic and alcohol-related liver conditions.