A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
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
Eli Lilly and Company
204 participants
Nov 28, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.
Eligibility
Inclusion Criteria2
- 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 cycle.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria8
- Have symptomatic or untreated central nervous system (CNS) metastases.
- Have an established diagnosis of uncontrolled diabetes mellitus.
- Have a history of, or current evidence of, a clinically significant cardiac condition or QT/QTcF-related conditions.
- Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity
- Signs, symptoms or history of thyroid tumors
- Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy.
- Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D1.
- Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.
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Interventions
Administered SC
Administered SC
5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally
Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV
Locations(67)
View Full Details on ClinicalTrials.gov
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NCT07169851