Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05134662 | ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM) | PHASE1 | COMPLETED | 55 | — | — | Feb 1, 2022 | Mar 9, 2023 | Jun 24, 2025 | 7 | United States |
| Arm | Type | Description |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | placebo 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 the performance of any study procedures * Male or female volunteers, age 18 to 65 years, inclusive * Overweight to obese (BMI \>/=28.0 kg/m2) * Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening...