A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease

What this Trial Is About

Researchers are evaluating LY3537021 to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This phase 2, double-blind, placebo-controlled study aims to assess both the effectiveness and safety of LY3537021 when added to standard antiemetic treatments. Participants are adults who have not previously received chemotherapy and are planned to receive specific chemotherapy drugs. Before chemotherapy, participants receive either LY3537021 or a placebo, both given as a subcutaneous injection. Alongside this, they receive standard of care antiemetic therapies, which may be given orally, intravenously, or through the skin. The chemotherapy drugs used include cisplatin or anthracycline and cyclophosphamide, administered intravenously. The study includes a randomized assignment to one of the two treatment groups and is expected to last about two months for each participant. Participants will be monitored for nausea and vomiting responses up to 120 hours after chemotherapy infusion. Researchers will collect data on complete response rates, nausea levels, and medication use. Pharmacokinetics of LY3537021 will also be assessed during the treatment cycles. Safety will be monitored throughout the study, and participants will be involved until all study parts are completed, with various assessments done at regular intervals.

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer