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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07284979 | Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes | PHASE3 | RECRUITING | 1,200 | — | — | Dec 30, 2025 | Apr 17, 2028 | Jun 8, 2026 | 33 | United States, Australia |
| NCT07284875 | Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes | PHASE3 | RECRUITING | 1,800 | — | — | Dec 18, 2025 | Mar 27, 2028 | Jun 8, 2026 | 37 | United States, Australia +1 |
| NCT07458269 | Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes | PHASE2 | RECRUITING | 250 | — | — | Mar 4, 2026 | Jun 1, 2027 | Apr 20, 2026 | 33 | United States |
| Arm | Type | Description |
|---|---|---|
| KAI-9531: Dose 1 | EXPERIMENTAL | Participants will receive Dose 1 of KAI-9531 once weekly. |
| KAI-9531: Dose 2 | EXPERIMENTAL | Participants will receive Dose 2 of KAI-9531 once weekly. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide once weekly. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to KAI-9531 once weekly. |
| KAI-9531: Dose 3 | EXPERIMENTAL | Participants will receive Dose 3 of KAI-9531 once weekly. |
| KAI-9531: Dose 4 | EXPERIMENTAL | Participants will receive Dose 4 of KAI-9531 once weekly. |
| Name | Type | Description |
|---|---|---|
| KAI-9531 | DRUG | SC Injection |
| Semaglutide | DRUG | SC Injection |
| Placebo | DRUG | SC Injection |
Key Inclusion Criteria: * BMI ≥35 kilograms per square meter (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus. * Started medications wit...