RecruitingPhase 2

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

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

Lead sponsor

Eli Lilly and Company

Asset

LY3537021

Subcutaneous · GIP agonist

Listed sites

Recruiting sites

Estimated enrollment

204

Study population

Oncology

Eligibility highlights

Primary endpoint

•Complete Response (CR) in the Delayed Phase of CINV

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07169851

Org study ID27402

Secondary ID2025

Secondary ID2025-522204-24-00

Secondary IDJ2R-MC-YAADEli Lilly and Company

Secondary IDU1111-1322-9151World Health Organization

Timeline

Milestones

Study first posted2025-09-12actual

Study start2025-11-28actual

Last update posted2026-11-04actual

Primary completion2026-12estimated (month precision)

Study completion2027-02estimated (month precision)

Assets

Investigational agents

LY3537021

Who this study enrolls

Oncology

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

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

threshold achievement, event

Secondary/protocol endpoint

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

threshold achievement, event

Secondary/protocol endpoint

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)

concentration, descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:24 to 120 hours after first chemotherapy infusion

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Proportion of Participants with a CR to CINV

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

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.