Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALT-801 · 5 trials · 5 indications
Number of participants with one or more TEAEs
| Arm | Type | Description |
|---|---|---|
| ALT-801 Dose Level 1 | EXPERIMENTAL | - |
| ALT-801 Dose Level 2 | EXPERIMENTAL | - |
| ALT-801 Dose Level 3 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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 |
| 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 |
|---|---|---|
| ALT-801 | DRUG | Injected subcutaneously (SC) |
| Placebo | OTHER | Injected subcutaneously (SC) |
Inclusion Criteria: * Written informed consent signed prior to entry into the study * Male or female age 18 to 75 years, inclusive * Body mass index (BMI) ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 combined with at least one obesity-related comorbidity * At least one unsuccessful weight loss attempt per investig...
ALT-801 is an investigational small molecule being developed for obesity and overweight, non-alcoholic fatty liver disease (NAFLD), and type 2 diabetes. It has been studied in clinical trials enrolling adults in the United States with these conditions.
ALT-801 is being developed by Altimmune, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ALT.
ALT-801 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and is not approved by the FDA. All reported trials for ALT-801 have been completed.
ALT-801 has been studied in four completed clinical trials. These include NCT05006885 and NCT05292911 in patients with non-alcoholic fatty liver disease, NCT05134662 in patients with type 2 diabetes, and NCT05295875 in patients with obesity or overweight.
No alternative names for ALT-801 have been reported. It is referred to solely as ALT-801 in clinical trial records and by its developer, Altimmune, Inc.
The specific molecular target of ALT-801 has not been disclosed. It is a small molecule being studied for its effects on metabolic conditions including obesity, NAFLD, and type 2 diabetes.