Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ALT-801
Pemvidutide · 10 trials · 10 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
Number of participants with one or more TEAEs
| Arm | Type | Description |
|---|---|---|
| Pemvidutide 1.8 mg | EXPERIMENTAL | - |
| Pemvidutide 2.4 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Pemvidutide 1.2 mg | EXPERIMENTAL | - |
| ALT-801 Dose Level 1 | EXPERIMENTAL | - |
| ALT-801 Dose Level 2 | EXPERIMENTAL | - |
| ALT-801 Dose Level 3 | EXPERIMENTAL | - |
| ALT-801 1.2 mg | EXPERIMENTAL | 1.2 mg once weekly for 12 weeks |
| ALT-801 1.8 mg | EXPERIMENTAL | 1.8 mg once weekly for 12 weeks |
| ALT-801 2.4 mg | EXPERIMENTAL | 0.6 mg at Week 1, 1.2 mg at Week 2, 1.8 mg once weekly for 2 weeks (Weeks 3 and 4), and 2.4 mg once weekly for Weeks 5 through 12 |
| 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. |
| ALT-801 (Part 1) | EXPERIMENTAL | Single ascending dose (SAD) cohorts of ALT-801 |
| Placebo (Part 1) | PLACEBO_COMPARATOR | Single dose of placebo |
| ALT-801 (Part 2) | EXPERIMENTAL | Multiple ascending dose (MAD) cohorts of ALT-801 administered once weekly for 12 weeks |
| Placebo (Part 2) | PLACEBO_COMPARATOR | Placebo administered once weekly for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Pemvidutide | DRUG | Pemvidutide SC Injection |
| Placebo | OTHER | Placebo SC Injection |
| ALT-801 | DRUG | Injected subcutaneously (SC) |
| 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 being developed for alcohol use disorder, alcohol-associated liver disease, and metabolic dysfunction-associated steatohepatitis (MASH), which includes nonalcoholic steatohepatitis (NASH). It is an investigational therapy and has not been approved for any indication. Clinical studies are evaluating its use in adults with these liver and metabolic conditions.
Pemvidutide targets both the GLP-1 receptor and the glucagon receptor, a dual GLP-1/GCGR mechanism. It is a peptide therapeutic, reflected in the -tide naming class. This dual receptor activity is the basis for its investigation in metabolic and liver-related conditions such as MASH and alcohol-associated liver disease.
Pemvidutide is being developed by Altimmune, Inc., which trades under the ticker ALT. The company is advancing the asset across multiple programs, including a Phase 3 study in MASH and Phase 2 studies in alcohol-associated liver disease and alcohol use disorder. Pemvidutide has received FDA Fast Track designation.
Pemvidutide is in Phase 2 and Phase 3 clinical development. A Phase 3 trial in MASH is currently recruiting, while Phase 2 studies in alcohol-associated liver disease and alcohol use disorder have been conducted. Pemvidutide is investigational and has not been approved by the FDA for any indication.
Pemvidutide has been studied in several trials, including the Phase 3 NCT07795164 in MASH, the Phase 2 RESTORE trial NCT07009860 in alcohol-associated liver disease, the Phase 2 RECLAIM study NCT06987513 in alcohol use disorder, and the Phase 2 IMPACT trial NCT05989711 in NASH. These trials enrolled adults aged 18 and older.
Pemvidutide is not approved by the FDA and remains an investigational therapy in clinical development. It has received FDA Fast Track designation, which is intended to expedite review of drugs addressing serious conditions. The most advanced program is a Phase 3 trial in MASH that is currently recruiting participants in the United States.