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Study of LY3537021 for Chemotherapy-Induced Nausea and Vomiting

This study is testing a drug called LY3537021 to see how well it prevents nausea and vomiting caused by chemotherapy in adults with cancer. Participants will receive either LY3537021 or a placebo (an inactive substance), along with standard anti-nausea medications and their regular chemotherapy (cisplatin or anthracycline and cyclophosphamide). The study aims to find out if LY3537021 can help more people avoid nausea and vomiting in the days after chemotherapy. You might be able to join if you are starting certain types of chemotherapy and are at least 18 years old. The study is currently unclear on its recruitment status and plans to enroll about 204 people. The study will last about 2 months for each participant.

Study design
This is an interventional study involving approximately 204 participants. Participants will receive either LY3537021, a placebo, or standard anti-nausea treatments.
What's involved
Participants will be in the study until all parts are finished, which could take about 2 months. They will receive study drugs and their regular chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured between 24 and 120 hours after the first chemotherapy infusion.

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NCT07169851

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Eli Lilly and Company
~204 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY3537021PlaceboStandard of Care Antiemetic TherapiesBackground Chemotherapy

At a glance

Recruiting sites
61 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV
Measured over 24 to 120 hours after first chemotherapy infusion

Conditions

Nausea
Vomiting
Drug-Related Side Effects and Adverse Reactions
Neoplasms

Explore related trials

Chemotherapy-Related Nausea and/or VomitingNeoplasm

Where it's being run

68 sites across 22 states
Turkey (Türkiye)9
Spain7
Australia5
China5
Romania5
Taiwan5
California4
Italy4

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV24 to 120 hours after first chemotherapy infusion

    CR defined as no vomiting and no rescue medication