Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY3841136
Eloralintide · 18 trials · 14 indications
Change from Baseline in the WOMAC Pain Subscale Score
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
PK: AUC of Eloralintide and Tirzepatide
PK: Cmax of Eloralintide and Tirzepatide
PK: AUC of Eloralintide and Tirzepatide
PK: Cmax of Eloralintide and Tirzepatide
PK: AUC of Eloralintide
PK: Cmax of Eloralintide
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| EloraTZP Dose 1 | EXPERIMENTAL | Participants will receive EloraTZP subcutaneously (SC) |
| EloraTZP Dose 2 | EXPERIMENTAL | Participants will receive EloraTZP SC |
| EloraTZP Dose 3 | EXPERIMENTAL | Participants will receive EloraTZP SC |
| EloraTZP Dose 4 | EXPERIMENTAL | Participants will receive EloraTZP SC |
| EloraTZP Dose 5 | EXPERIMENTAL | Participants will receive EloraTZP SC |
| Tirzepatide | EXPERIMENTAL | Participants will receive tirzepatide SC |
| Eloralintide | EXPERIMENTAL | Participants will receive eloralintide SC |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| EloraTZP | EXPERIMENTAL | Participants will receive EloraTZP subcutaneously (SC) |
| Eloralintide (YSA1) | EXPERIMENTAL | Participants will receive eloralintide subcutaneously (SC) |
| Placebo (YSA1) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide (YSA2) | EXPERIMENTAL | Participants will receive eloralintide SC |
| Placebo (YSA2) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide Dose 1 | EXPERIMENTAL | Participants will receive eloralintide subcutaneously (SC) |
| Eloralintide Dose 2 | EXPERIMENTAL | Participants will receive eloralintide SC |
| Eloralintide Dose 3 | EXPERIMENTAL | Participants will receive eloralintide SC |
| Eloralintide Dose 4 | EXPERIMENTAL | Participants will receive eloralintide SC |
| Eloralintide (YOA1) | EXPERIMENTAL | Participants will receive eloralintide subcutaneously (SC) |
| Placebo (YOA1) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| Eloralintide (YOA2) | EXPERIMENTAL | Participants will receive eloralintide SC |
| Placebo (YOA2) | PLACEBO_COMPARATOR | Participants will receive placebo SC |
| LY3841136 Dose 1 | EXPERIMENTAL | Participants will receive LY3841136 subcutaneously (SC) |
| LY3841136 Dose 2 | EXPERIMENTAL | Participants will receive LY3841136 SC |
| LY3841136 Dose 3 | EXPERIMENTAL | Participants will receive LY3841136 SC |
| LY3841136 Dose 1 + Tirzepatide Dose 1 | EXPERIMENTAL | Participants will receive LY3841136 SC and Tirzepatide SC |
| LY3841136 Dose 2 + Tirzepatide Dose 1 | EXPERIMENTAL | Participants will receive LY3841136 SC and Tirzepatide SC |
| LY3841136 Dose 2 + Tirzepatide Dose 2 | EXPERIMENTAL | Participants will receive LY3841136 SC and Tirzepatide SC |
| LY3841136 Dose 3 + Tirzepatide Dose 3 | EXPERIMENTAL | Participants will receive LY3841136 SC and Tirzepatide SC |
| Tirzepatide Dose 3 | ACTIVE_COMPARATOR | Participants will receive Tirzepatide SC |
| LY3841136 Dose 2 + Tirzepatide Dose 3 | EXPERIMENTAL | Participants will receive LY3841136 SC and Tirzepatide SC |
| 1 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks. |
| 3 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 3 mg SC QW for 48 weeks. |
| 6 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 6 mg SC QW for 48 weeks. |
| 9 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 9 mg SC QW for 48 weeks. |
| 6/9 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks. |
| 3/6/9 mg Eloralintide | EXPERIMENTAL | Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks. |
| Eloralintide and combined oral contraceptive | EXPERIMENTAL | Eloralintide administered subcutaneously (SC), combined oral contraceptive administered orally |
| Eloralintide Cohort 1 | EXPERIMENTAL | Eloralintide administered subcutaneously (SC) |
| Eloralintide Cohort 2 | EXPERIMENTAL | Eloralintide administered SC |
| Eloralintide Cohort 3 | EXPERIMENTAL | Eloralintide administered SC |
| Eloralintide Cohort 4 | EXPERIMENTAL | Eloralintide administered SC |
| Eloralintide (Group 1) | EXPERIMENTAL | Eloralintide administered subcutaneously (SC) in a control group of participants with normal renal function |
| Eloralintide (Groups 2 and 3) | EXPERIMENTAL | Eloralintide administered SC in groups of participants with impaired renal function |
| Eloralintide (Group 3) | EXPERIMENTAL | Eloralintide administered SC in a group of participants with end-stage renal disease (ESRD) on stable hemodialysis |
| Eloralintide (Normal Hepatic Function) | EXPERIMENTAL | Eloralintide administered subcutaneously (SC) |
| Eloralintide (Mild Hepatic Impairment) | EXPERIMENTAL | Eloralintide administered SC |
| Eloralintide (Moderate Hepatic Impairment) | EXPERIMENTAL | Eloralintide administered SC |
| Eloralintide (Severe Hepatic Impairment) | EXPERIMENTAL | Eloralintide administered SC |
| Eloralintide and Tirzepatide-Cohorts A-D | EXPERIMENTAL | Eloralintide and Tirzepatide administered subcutaneously (SC) |
| Eloralintide-Cohorts E and F | EXPERIMENTAL | Eloralintide administered SC |
| Part A: LY3841136 | EXPERIMENTAL | LY3841136 administered subcutaneously (SC) |
| Part A: Placebo | PLACEBO_COMPARATOR | Placebo administered SC |
| Part B: Tirzepatide + LY3841136-Placebo | EXPERIMENTAL | Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC |
| Part B: LY3841136 + Tirzepatide-Placebo | EXPERIMENTAL | LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC |
| Part B: LY3841136 + Tirzepatide | EXPERIMENTAL | LY3841136 administered SC along with Tirzepatide administered SC |
| Part B: LY3841136-Placebo + Tirzepatide-Placebo | PLACEBO_COMPARATOR | Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC |
| LY3841136 (Part A) | EXPERIMENTAL | Single ascending doses of LY3841136 administered subcutaneously (SC). |
| LY3841136 (Part B) | EXPERIMENTAL | Multiple ascending doses of LY3841136 administered SC. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered SC. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered SC. |
| Name | Type | Description |
|---|---|---|
| eloralintide and tirzepatide | DRUG | Administered SC |
| Eloralintide | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| LY3841136 | DRUG | Administered SC |
| Combined oral contraceptive | DRUG | levonorgestrel and ethinyl estradiol administered orally |
| Acetaminophen | DRUG | Administered Oral Solution |
| LY3841136-Placebo | DRUG | Administered SC |
| Tirzepatide-Placebo | DRUG | Administered SC |
Inclusion Criteria: * Have a stable self-reported body weight (\<5% body weight change) for 90 days prior to screening * Have a BMI of ≥35 kg/m2 at screening * Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight Exclusion Criteria: * Have a prior or planne...
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Eloralintide is being developed for obesity, overweight, and related conditions including osteoarthritis and obstructive sleep apnea. Eli Lilly is studying it in adults with obesity or overweight, both with and without type 2 diabetes, across a Phase 3 program and earlier Phase 1 studies.
Eloralintide is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the clinical program, including the Phase 3 studies of EloraTZP in obesity and overweight and the Phase 1 studies of eloralintide (LY3841136).
Eloralintide is in Phase 3 clinical development. Two Phase 3 studies of EloraTZP are planned in adults with obesity or overweight, one in participants with type 2 diabetes and one without. Earlier Phase 1 studies of eloralintide (LY3841136) are also listed, with some currently recruiting.
Eloralintide trials include NCT07881458, a Phase 3 study in obesity or overweight with type 2 diabetes, and NCT07881432, a Phase 3 study in obesity without type 2 diabetes. Phase 1 studies include NCT07808060 in female participants and NCT07738614 in participants with obesity or overweight.
No. Eloralintide and tirzepatide are separate drug candidates from Eli Lilly. Eloralintide is studied under the code LY3841136 and in combination studies labeled EloraTZP, while tirzepatide is a different Lilly medicine. The two names refer to distinct programs and should not be used interchangeably.
The Eloralintide clinical program lists seven trials with a combined planned enrollment of about 5,478 participants. The largest is the Phase 3 obesity study NCT07881432 with 2,115 participants, followed by NCT07881458 with 1,000 participants. The Phase 1 studies enroll 34 and 56 participants.