Recruiting

Phase 2

LY35327021A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

Sponsor:

Eli Lilly and Company

Code:

NCT07169851

Conditions

Nausea

Vomiting

Drug-Related Side Effects and Adverse Reactions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY3537021

Placebo

Standard of Care Antiemetic Therapies

Background Chemotherapy

Study Details

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.

Conditions

Nausea

Vomiting

Drug-Related Side Effects and Adverse Reactions

Neoplasms

Study ID

NCT07169851

Start date

Nov 28, 2025

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY3537021 + 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

placebo comparator: Placebo + Antiemetic Therapies

Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label

Interventions

LY3537021

Administered SC

Placebo

Administered SC

Standard of Care Antiemetic Therapies

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

Background Chemotherapy

Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Primary outcome measure

Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV [ Time Frame: 24 to 120 hours after first chemotherapy infusion ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Marin Cancer Care

Recruiting

Greenbrae, California, United States, 94904

Principal Investigator:

Cyrus Mazidi

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

Contacts

714-252-9415

Principal Investigator:

Sudarsan Kollimuttathuillam

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

Principal Investigator:

Nihal Abdulla

BASS Cancer Center

Recruiting

Walnut Creek, California, United States, 94598

Principal Investigator:

Jewel Johl

UCHealth Harmony

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

970-297-6150

Principal Investigator:

Steven Schuster

Clavis Medical

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

786-723-4001

Principal Investigator:

Eloy Roman

BRCR Global - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Contacts

561-477-0614

Principal Investigator:

Chintan Gandhi

Summit Cancer Care, PC

Recruiting

Savannah, Georgia, United States, 31405

Contacts

912-651-5771

Principal Investigator:

Michael Chahin

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

630-560-0121

Principal Investigator:

Srilata Gundala

Indiana University Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Tarah Ballinger

North Mississippi Hematology and Oncology Associates

Recruiting

Tupelo, Mississippi, United States, 38801

Principal Investigator:

Amit Jain

Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Olivia Seecof

Oncology Specialists of Charlotte

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

704-342-1900

Principal Investigator:

Justin Favaro

Southern Oncology Specialists

Recruiting

Huntersville, North Carolina, United States, 28078

Principal Investigator:

William Mitchell

Asante Rogue Regional Medical Center

Recruiting

Medford, Oregon, United States, 97504

Contacts

541-789-5003

Principal Investigator:

Alison Savage

World Research Link

Recruiting

Baytown, Texas, United States, 77521

Contacts

833-832-8328

Principal Investigator:

Amir Rasheed

John Peter Smith Hospital

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

817-702-8049

Principal Investigator:

Kalyani Narra

Community Cancer Trials of Utah

Recruiting

Ogden, Utah, United States, 84405

Contacts

801-689-3909

Principal Investigator:

Carl Gray

Cancer Care Northwest

Recruiting

Spokane, Washington, United States, 99202

Principal Investigator:

Saritha Thumma

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Chemotherapy-Induced Nausea and Vomiting (CINV)
Anthracycline and cyclophosphamide (AC)
Glucose-dependent Insulinotropic Peptide (GIP)
Incretins
Cisplatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.