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

ClinicalTrials.gov ID

NCT07169851

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

204Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

Nov 28, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Feb 2027Estimated

Official Title

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

Brief 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.

• Nausea
• Vomiting
• Drug-Related Side Effects and Adverse Reactions
• Neoplasms

• LY3537021
• Placebo
• Standard of Care Antiemetic Therapies
• Background Chemotherapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

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