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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06124807 | A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight | PHASE2 | COMPLETED | 179 | — | — | Nov 17, 2023 | Jul 9, 2025 | Apr 21, 2026 | 29 | United States |
Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
| Arm | Type | Description |
|---|---|---|
| 3/6 Milligrams (mg) Mazdutide | EXPERIMENTAL | Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48. |
| 10 mg Mazdutide | EXPERIMENTAL | Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48. |
| 16 mg Mazdutide | EXPERIMENTAL | Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then16 mg from Weeks 20-48. |
| Placebo | PLACEBO_COMPARATOR | Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48. |
| Name | Type | Description |
|---|---|---|
| Mazdutide | DRUG | Administered subcutaneous (SC) |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: W8M-MC-OXA1: * Are males and females who agree to abide by the reproductive and contraceptive requirements W8M-MC-CWMM: * Have a BMI ≥27 kilograms per square meter (kg/m²) Exclusion Criteria: W8M-MC-OXA1: * Have any prior diagnosis of diabetes mellitus, that is type 2 diab...