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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04881760 | A Study of LY3437943 in Participants Who Have Obesity or Are Overweight | PHASE2 | COMPLETED | 338 | — | — | May 20, 2021 | Nov 22, 2022 | Sep 13, 2023 | 28 | United States, Puerto Rico |
| NCT06313528 | A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943 | PHASE1 | COMPLETED | 85 | — | — | Mar 20, 2024 | Aug 26, 2025 | Sep 23, 2025 | 3 | United States |
| NCT05445232 | A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants | PHASE1 | COMPLETED | 32 | — | — | Jul 8, 2022 | Feb 24, 2023 | Apr 18, 2023 | 2 | United States |
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
PK: AUC\[0-∞\] of Midazolam
PK: Cmax of Midazolam
PK: AUC\[0-∞\] of Warfarin
PK: AUC\[0-∞\] of Caffeine
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to LY3437943 administered as subcutaneous (SC) injection once-weekly (QW). |
| 1 milligram (mg) LY3437943 | EXPERIMENTAL | Participants received 1 mg LY3437943 administered as SC injection QW. |
| 4 mg LY3437943 (2 mg) | EXPERIMENTAL | Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW. |
| 4 mg LY3437943 | EXPERIMENTAL | Participants received 4 mg LY3437943 administered as SC injection QW. |
| 8 mg LY3437943 (2 mg) | EXPERIMENTAL | Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW. |
| 8 mg LY3437943 (4 mg) | EXPERIMENTAL | Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW. |
| 12 mg LY3437943 (2 mg) | EXPERIMENTAL | Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, 8 mg LY3437943 and then 12 mg LY3437943 administered as SC injection QW. |
| LY3437943 | EXPERIMENTAL | LY3437943 administered subcutaneously (SC) |
| LY3437943 + Drug Cocktail | EXPERIMENTAL | Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, \& 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2. |
| Name | Type | Description |
|---|---|---|
| LY3437943 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Midazolam | DRUG | Administered orally. |
| Warfarin | DRUG | Administered orally. |
| Caffeine | DRUG | Administered orally. |
Inclusion Criteria: * Participants must have a Body Mass Index (BMI) ) ≥30 and ≤50 kilograms per square meter (kg/m²), or ≥27 kg/m² and \<30 kg/m², with at least one of the following comorbidities: hypertension, dyslipidemia, cardiovascular disease * Participants must be willing to learn how to sel...