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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Vomiting; Nausea; Drug-Related Side Effects and Adverse Reactions; Neoplasms

Treatments: Drug: Background Chemotherapy; Drug: Standard of Care Antiemetic Therapies; Drug: Placebo; Drug: LY3537021

Study type: Interventional

Funder types: Industry

Identifiers

NCT07169851

2025-522204-24-00 (EU Trial (CTIS) Number)

27402

U1111-1322-9151 (Other Identifier)

J2R-MC-YAAD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups, including a placebo group

LY3537021 + Antiemetic Therapies

Experimental group

Description:

Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label

Treatment:

Drug: LY3537021

Drug: Standard of Care Antiemetic Therapies

Drug: Background Chemotherapy

Placebo + Antiemetic Therapies

Placebo Comparator group

Description:

Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label

Treatment:

Drug: Placebo

Drug: Standard of Care Antiemetic Therapies

Drug: Background Chemotherapy