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

Not Applicable

Not yet recruiting

• Conditions: Nausea; Vomiting; Neoplasms; Drug-Related Side Effects and Adverse Reactions
• Interventions: Drug: LY3537021; Drug: Placebo; Drug: Standard of Care Antiemetic Therapies; Drug: Background Chemotherapy

• Registration Number: NCT07169851
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-10-01
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3537021 + Antiemetic Therapies	LY3537021	Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
LY3537021 + Antiemetic Therapies	Standard of Care Antiemetic Therapies	Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
LY3537021 + Antiemetic Therapies	Background Chemotherapy	Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
Placebo + Antiemetic Therapies	Placebo	Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
Placebo + Antiemetic Therapies	Standard of Care Antiemetic Therapies	Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
Placebo + Antiemetic Therapies	Background Chemotherapy	Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label

Primary Outcome Measures

Name	Time	Method
Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV	24 to 120 hours after first chemotherapy infusion	CR defined as no vomiting and no rescue medication

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants with a CR to CINV	Zero to 120 hours after the first chemotherapy infusion	CR defined as no vomiting and no rescue medication
Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication	Zero to 120 hours after the first chemotherapy infusion	Participants will self-report nausea severity via three questions. Items are rated on a 10-point numeric scale. Scores range from 0 (no nausea) to 10 (worst possible nausea). Lower scores are better.
Proportion of Participants with a Response of Less than or Equal to (≤)3 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication	Zero to 120 hours after the first chemotherapy infusion	Participants will self-report nausea severity via three questions. Items are rated on a 10-point numeric scale. Scores range from 0 (no nausea) to 10 (worst possible nausea). Lower scores are better.
Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021	From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)

Trial Locations

Locations (68)

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

OSF Little Company of Mary Medical Center; 🇺🇸 Evergreen Park, Illinois, United States

Hope and Healing Cancer Services; 🇺🇸 Hinsdale, Illinois, United States

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