Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3537021 · 3 trials · 6 indications
CR defined as no vomiting and no rescue medication
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
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 |
|---|---|---|
| LY3537021 + Antiemetic Therapies | EXPERIMENTAL | Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label |
| Placebo + Antiemetic Therapies | PLACEBO_COMPARATOR | Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label |
| LY3537021 + Liraglutide (Part A) | EXPERIMENTAL | Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC. |
| Liraglutide + Placebo (Part A) | EXPERIMENTAL | Liraglutide administered SC followed by liraglutide in combination with placebo given SC. |
| LY3537021 + Liraglutide & Placebo + Liraglutide (Part B) | EXPERIMENTAL | LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2. |
| Placebo + Liraglutide & LY3537021 + Liraglutide Part B) | EXPERIMENTAL | Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2. |
| LY3537021 (Part A/Healthy) | EXPERIMENTAL | LY3537021 administered subcutaneously (SC) to healthy participants. |
| LY3537021 (Part A/Type 2 Diabetes) | EXPERIMENTAL | LY3537021 administered SC to participants with type 2 diabetes mellitus (T2DM). |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered SC. |
| LY3537021 (Part B/Healthy) | EXPERIMENTAL | LY3537021 administered SC to healthy participants. |
| LY3537021 (Part B/Type 2 Diabetes) | EXPERIMENTAL | LY3537021 administered SC to participants with T2DM. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered SC. |
| Name | Type | Description |
|---|---|---|
| LY3537021 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Standard of Care Antiemetic Therapies | DRUG | 5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally |
| Background Chemotherapy | DRUG | Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV |
| Liraglutide | DRUG | Administered SC. |
Inclusion Criteria: * Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg/m²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each c...
LY3537021 is an investigational small molecule being studied for the treatment of nausea and vomiting caused by chemotherapy in adults with cancer. It has also been evaluated in healthy participants and in participants with type 2 diabetes mellitus in earlier phase trials.
LY3537021 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY.
LY3537021 is currently in Phase 2 clinical development. It is being studied in a Phase 2 trial for chemotherapy-induced nausea and vomiting, following completion of two Phase 1 trials in healthy participants.
LY3537021 has been studied in three clinical trials. NCT04586907 and NCT05444569 were completed Phase 1 studies in healthy participants. NCT07169851 is a recruiting Phase 2 study evaluating LY3537021 for nausea and vomiting caused by chemotherapy in adults with cancer.
LY3537021 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development, and its safety and efficacy have not yet been established for any use.
Yes, LY3537021 has been studied in healthy volunteers. Two completed Phase 1 trials, NCT04586907 and NCT05444569, enrolled healthy participants in Singapore. The ongoing Phase 2 trial enrolls adults with cancer.