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 developed by Altimmune, Inc. for metabolic and liver conditions. It has been studied in non-alcoholic fatty liver disease, obesity and overweight, and type 2 diabetes. It is a clinical-stage candidate that has not been approved for any indication.
ALT-801 targets the GLP-1 and glucagon receptors, a dual receptor approach. GLP-1 receptor activity is associated with glucose control and appetite regulation, while glucagon receptor activity is associated with energy expenditure and lipid metabolism. Both receptors are part of the same receptor class.
ALT-801 is developed by Altimmune, Inc., which trades on the Nasdaq under the ticker ALT. The company has run its ALT-801 clinical program in the United States, enrolling participants with obesity, overweight, non-alcoholic fatty liver disease, and type 2 diabetes.
ALT-801 is in Phase 1 development overall, with a Phase 2 study also completed in obesity. It is investigational and has not been approved by the FDA for any indication. The program includes completed trials across obesity, non-alcoholic fatty liver disease, and type 2 diabetes.
ALT-801 has been evaluated in completed trials including NCT05295875 in obesity, NCT05292911 and NCT05006885 in non-alcoholic fatty liver disease, and NCT05134662 in type 2 diabetes. These studies were randomized, double-blind, and placebo-controlled, with a combined enrollment of 391 participants across the program.
ALT-801 is the name used for this Altimmune small molecule across its clinical program. It has been studied under this designation in trials covering obesity and overweight, non-alcoholic fatty liver disease, and type 2 diabetes, all conducted in the United States with participants aged 18 years and older.