Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3437943 · 14 trials · 7 indications
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.
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
PK: AUC0-24 of Ethinyl Estradiol
PK: Cmax of Ethinyl Estradiol
PK: Tmax of Ethinyl Estradiol
PK: AUC0-24 of Drospirenone
PK: Cmax of Drospirenone
PK: Tmax of Drospirenone
PK: Cmax of LY3437943
PK: AUC\[0-tlast\] of LY3437943
PK: AUC(0-∞) of LY3437943
Part A: PK: AUC(0-∞) of LY3437943
Part A: PK: Cmax of LY3437943
PK: AUC0-∞ of LY3437943
PK: Cmax of LY3437943
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
PK: AUC\[0-∞\] of Midazolam
PK: Cmax of Midazolam
PK: AUC\[0-∞\] of Warfarin
PK: AUC\[0-∞\] of Caffeine
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| 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. |
| 0.5 milligrams (mg) LY3437943 | EXPERIMENTAL | Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW). |
| 4 mg LY3437943 (4 mg) | EXPERIMENTAL | Participants received 4 mg LY3437943 administered as SC injection QW. |
| 1.5 mg Dulaglutide | ACTIVE_COMPARATOR | Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW. |
| LY3437943 | EXPERIMENTAL | LY3437943 administered subcutaneously (SC) |
| LY3437943 + Combined Oral Contraceptive (COC) | EXPERIMENTAL | The COC ethinyl estradiol and drospirenone administered orally in combination with LY3437943 administered subcutaneously (SC). |
| LY3437943 - Test | EXPERIMENTAL | A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation) |
| LY3437943 - Reference | ACTIVE_COMPARATOR | A single dose of LY3437943 administered by SC injection via a reference device (reference formulation) |
| LY3437943 (Part A) | EXPERIMENTAL | LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen |
| LY3437943 (Part B) | EXPERIMENTAL | LY3437943 administered intravenously (IV) |
| LY3437943 (Normal Hepatic Function) | EXPERIMENTAL | LY3437943 administered subcutaneously (SC). |
| LY3437943 (Severe Hepatic Impairment) | EXPERIMENTAL | LY3437943 administered SC. |
| LY3437943 (Moderate Hepatic Impairment) | EXPERIMENTAL | LY3437943 administered SC. |
| LY3437943 (Mild Hepatic Impairment) | EXPERIMENTAL | LY3437943 administered SC. |
| [¹⁴C]-LY3437943 | EXPERIMENTAL | Single dose of \[¹⁴C\]-LY3437943 administered subcutaneously (SC). |
| LY3437943 (Control) | EXPERIMENTAL | LY3437943 administered subcutaneous (SC) to participants with normal renal function |
| LY3437943 (Severe Renal Impairment) | EXPERIMENTAL | LY3437943 administered SC to participants with severe renal impairment |
| LY3437943 (End-Stage Renal Disease) | EXPERIMENTAL | LY3437943 administered SC to participants with end-stage renal disease |
| 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. |
| Dulaglutide | ACTIVE_COMPARATOR | Dulaglutide administered SC |
| Name | Type | Description |
|---|---|---|
| LY3437943 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Dulaglutide | DRUG | Administered SC |
| Ethinyl Estradiol | DRUG | Administered orally |
| Drospirenone | DRUG | Administered orally |
| Test | DEVICE | Used to administer LY3437943 SC |
| Reference | DEVICE | Used to administer LY3437943 SC |
| [¹⁴C]-LY3437943 | 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...
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LY3437943 is an investigational small molecule being developed by Eli Lilly and Company for metabolic conditions including obesity, type 2 diabetes, and overweight. It is currently in Phase 1 clinical development and has not been approved by the FDA.
LY3437943 is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is in Phase 1 clinical trials for metabolic indications such as obesity and type 2 diabetes.
LY3437943 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All six clinical trials for LY3437943 have been completed, with no active trials currently ongoing.
LY3437943 has completed six Phase 1 clinical trials, including NCT03841630 in healthy participants in Singapore, NCT05757531 in healthy males in the United States, NCT05916560 in participants with impaired and normal liver function, and NCT05959096 in healthy participants with a high body mass index.
LY3437943 is also known as retatrutide. It is an investigational small molecule developed by Eli Lilly and Company for metabolic conditions including obesity and type 2 diabetes. The drug is currently in Phase 1 clinical development.