Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3537021 · 2 trials · 6 indications
CR defined as no vomiting and no rescue medication
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 (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 |
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 developed by Eli Lilly and Company for nausea and vomiting caused by chemotherapy in adults with cancer. It is also being studied in type 2 diabetes mellitus. It is not approved and remains in clinical development, with a Phase 2 trial currently recruiting.
LY3537021 is being studied to treat nausea and vomiting caused by chemotherapy in adults with cancer, and it has also been evaluated in type 2 diabetes mellitus. The chemotherapy-induced nausea and vomiting program is the more advanced, with a Phase 2 trial now recruiting participants.
LY3537021 is 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 program evaluating the small molecule in chemotherapy-induced nausea and vomiting and in type 2 diabetes mellitus.
LY3537021 is in Phase 2 development. The Phase 2 trial NCT07169851 is evaluating it for nausea and vomiting caused by chemotherapy in adults with cancer and is currently recruiting. An earlier Phase 1 study, NCT04586907, in healthy participants and participants with type 2 diabetes mellitus has been completed.
The active trial is NCT07169851, a Phase 2 randomized, double-blind, placebo-controlled study of LY3537021 for chemotherapy-induced nausea and vomiting in adults with cancer, enrolling 204 participants across the United States, Australia, China, France, Italy, Japan, Romania, Spain, Taiwan, and Turkey. The completed Phase 1 trial NCT04586907 enrolled 85 participants in Singapore.
LY3537021 is a small molecule therapeutic. It is being developed as an oral or systemic small molecule agent, and its clinical program pairs a Phase 2 study in chemotherapy-induced nausea and vomiting with a completed Phase 1 study that included participants with type 2 diabetes mellitus.