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NCT Number: NCT07169851

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

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.

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Key information

Conditions

Nausea Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ballarat Health Services, Ballarat Central, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3537021

Drug

Administered SC

Placebo

Drug

Administered SC

Standard of Care Antiemetic Therapies

Drug

5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

Background Chemotherapy

Drug

Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Primary outcomes

  1. Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV

    Time frame: 24 to 120 hours after first chemotherapy infusion

    CR defined as no vomiting and no rescue medication

Secondary outcomes

  1. Proportion of Participants with a CR to CINV

    Time frame: Zero to 120 hours after the first chemotherapy infusion

    CR defined as no vomiting and no rescue medication

  2. Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021

    Time frame: From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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