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LY3537021 for preventing chemo-related nausea and vomiting in adults

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

Phase 2 Interventional Eli Lilly and Company · NCT07169851

This trial will test whether adding LY3537021 to standard anti-nausea care helps prevent nausea and vomiting in adults starting AC or high-dose cisplatin chemotherapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment204 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsChemotherapy
Locations66 sites (Greenbrae, California and 65 other locations)
Trial IDNCT07169851 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial in adults who are chemotherapy-naive and scheduled to receive anthracycline+cyclophosphamide (AC) or cisplatin ≥70 mg/m² on Day 1 of each cycle. Participants will receive background chemotherapy and standard antiemetic therapies, plus either LY3537021 or placebo, and will be followed through the acute and delayed CINV observation period (days 1–5) with safety monitoring for about two months. The study will compare rates and severity of nausea and vomiting and collect safety and tolerability data. Key exclusions include symptomatic or untreated CNS metastases, uncontrolled diabetes, certain cardiac/QT conditions, recent use of GIP/GLP-1 receptor agonists, and history of thyroid tumors.

Who should consider this trial

Good fit: Ideal candidates are adults with cancer who are chemotherapy-naive, have ECOG performance status 0–2, and are scheduled to receive AC or cisplatin ≥70 mg/m² as part of their treatment.

Not a fit: Patients with symptomatic CNS metastases, uncontrolled diabetes, significant cardiac or QT-related problems, recent GIP/GLP-1 agonist use, or another clear cause for nausea/vomiting are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, LY3537021 could provide better control of chemotherapy-induced nausea and vomiting and improve patients' comfort during and after chemotherapy.

How similar studies have performed: Standard antiemetic regimens (5-HT3 antagonists, NK1 antagonists, dexamethasone, olanzapine) have established benefit, but targeting GIP/incretin pathways for CINV is a novel approach with limited prior clinical testing.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Greenbrae, California and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NauseaVomitingDrug-Related Side Effects and Adverse ReactionsNeoplasmsChemotherapy-Induced Nausea and VomitingAnthracycline and cyclophosphamideGlucose-dependent Insulinotropic PeptideIncretins
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.