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A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07169851•Eli Lilly and Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 cycle.
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria

•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.

Locations (67)

Marin Cancer Care

Greenbrae, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

BASS Cancer Center

Walnut Creek, California, United States

UCHealth Harmony

Fort Collins, Colorado, United States

Clavis Medical

Miami Lakes, Florida, United States

BRCR Global - Tamarac

Tamarac, Florida, United States

Summit Cancer Care, PC

Savannah, Georgia, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

North Mississippi Hematology and Oncology Associates

Tupelo, Mississippi, United States

Key Dates

Start Date

November 28, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

March 20, 2026

Enrollment

204

ESTIMATED participants

Conditions

NauseaVomitingDrug-Related Side Effects and Adverse ReactionsNeoplasms

Interventions

LY3537021

DRUG

Placebo

DRUG

Standard of Care Antiemetic Therapies

DRUG

Background Chemotherapy

DRUG

Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis

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