Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [¹⁴C]-LY3437943, Retatrutide
LY3437943 · 24 trials · 17 indications
A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).
ESKD is defined as the following individual components: persistent eGFR \<15 mL/min/1.73 m\^2 confirmed by 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant. Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.
The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate)
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.
Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL.
Change from baseline in total cDI for comparison of retatrutide with placebo
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
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 |
|---|---|---|
| Retatrutide Dose Escalation 1 | EXPERIMENTAL | Participants will receive retatrutide subcutaneously (SC) |
| Retatrutide Dose Escalation 2 | EXPERIMENTAL | Participants will receive retatrutide SC |
| Retatrutide Dose Escalation 3 | EXPERIMENTAL | Participants will receive retatrutide SC |
| Retatrutide Dose 1 | EXPERIMENTAL | Participants will receive retatrutide subcutaneously (SC) |
| Retatrutide Dose 2 | EXPERIMENTAL | Participants will receive retatrutide SC |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Retatrutide | EXPERIMENTAL | Participants will receive Retatrutide subcutaneously (SC) |
| Retatrutide Dose 1 to Retatrutide Dose 2 | EXPERIMENTAL | Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks |
| Retatrutide Dose 1 to Placebo | PLACEBO_COMPARATOR | Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks |
| Tirzepatide | ACTIVE_COMPARATOR | Participants will receive tirzepatide administered SC |
| Retatrutide Dose Level 1 | EXPERIMENTAL | Participants will receive retatrutide administered subcutaneously (SC). |
| Retatrutide Dose Level 2 | EXPERIMENTAL | Participants will receive retatrutide administered SC. |
| Retatrutide Dose Level 3 | EXPERIMENTAL | Participants will receive retatrutide administered SC. |
| Retatrutide Dose 3 | EXPERIMENTAL | Participants will receive retatrutide administered SC. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide administered SC. |
| Retatrutide Extension Period | EXPERIMENTAL | Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks. |
| 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 + 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 |
|---|---|---|
| Retatrutide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC |
| Semaglutide | DRUG | Administered SC. |
| LY3437943 | DRUG | Administered SC |
| Dulaglutide | DRUG | Administered SC |
| Ethinyl Estradiol | DRUG | Administered orally |
| Drospirenone | DRUG | Administered orally |
| Midazolam | DRUG | Administered orally. |
| Warfarin | DRUG | Administered orally. |
| Caffeine | DRUG | Administered orally. |
Inclusion Criteria: * Have a Body Mass Index (BMI) at screening * ≥ 30 kilogram per square meter (kg/m2) OR * ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease ...
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LY3437943 is an investigational small molecule developed by Eli Lilly and Company for metabolic conditions, including type 2 diabetes, obesity, and overweight. It has been studied in Phase 1 clinical trials. It is not an approved medicine and remains in clinical development.
LY3437943 is being studied for the treatment of type 2 diabetes mellitus, obesity, and overweight. The completed Phase 1 trials enrolled participants with obesity or overweight, including postmenopausal women and Chinese participants. No approved use has been established for LY3437943.
LY3437943 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 studies of the compound in obesity, overweight, and type 2 diabetes.
LY3437943 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and no active trials are ongoing. The studies were randomized, double-blind, and placebo-controlled, with a total enrollment of 455 participants across the completed trials.
Completed Phase 1 trials of LY3437943 include NCT06313528, which measured calorie consumption and usage in participants with obesity, NCT06039826 in postmenopausal women who were overweight or obese, NCT05548231 in Chinese participants with obesity or overweight, and NCT05445232, a drug-drug interaction study in obese participants.
Yes, [¹⁴C]-LY3437943 is an alternative name for LY3437943. The carbon-14 label refers to a radiolabeled form used in research, and both names refer to the same Eli Lilly investigational compound being studied in Phase 1 trials for obesity, overweight, and type 2 diabetes.