Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Eloralintide
LY3841136 · 16 trials · 13 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 |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo 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 | EXPERIMENTAL | Eloralintide administered subcutaneously (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 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| LY3841136 | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC |
| Combined oral contraceptive | DRUG | levonorgestrel and ethinyl estradiol administered orally |
| Acetaminophen | DRUG | Administered Oral Solution |
| Eloralintide and Tirzepatide | DRUG | Administered SC |
| LY3841136-Placebo | DRUG | Administered SC |
| Tirzepatide-Placebo | DRUG | Administered SC |
Inclusion Criteria: * Confirmed history of moderate-to-severe OSA * Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening * Have a BMI ≥27 kg/m2 at screening * Have a stable body weight (\<5% body weight change) for 90 days prior to screening * Have a history of at least one s...
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LY3841136 is an investigational small molecule developed by Eli Lilly and Company for obesity, overweight, hepatic insufficiency, and kidney disease. It is being studied both alone and in combination with tirzepatide. The drug is in clinical development and has been evaluated in Phase 1 and Phase 2 trials.
LY3841136 is being studied for weight management in adults with obesity or overweight, including those with type 2 diabetes, and for use in people with hepatic insufficiency or kidney disease. It is also being tested in combination with tirzepatide for weight management.
LY3841136 targets the amylin receptor. By acting on this receptor, the drug is designed to influence metabolic and weight-related pathways. The amylin receptor is a G protein-coupled receptor involved in satiety and glucose regulation.
LY3841136 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical trials evaluating the drug in obesity, hepatic insufficiency, and kidney disease.
LY3841136 is in Phase 1 and Phase 2 clinical development. It has not been approved by the FDA. The most advanced completed trial was a Phase 2 study in obesity and overweight with type 2 diabetes, while other studies are Phase 1.
LY3841136 has been studied in trials including NCT07426380 in renal impairment, NCT07401862 in hepatic insufficiency, NCT06603571 in obesity or overweight with type 2 diabetes, and NCT06297616 in Japanese participants with obesity or overweight. The renal and hepatic trials are ongoing or active.
Yes, LY3841136 is also known as eloralintide. The names refer to the same investigational drug. Clinical trial titles use both LY3841136 and eloralintide interchangeably.