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NauseaPhase 2NCT07169851

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

A Phase 2 study testing LY3537021 and Background Chemotherapy in people with Nausea and Vomiting, run by Eli Lilly and Company at 67 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LY3537021 and Background Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
67 sitesin 10 countries
Study dates
28 Nov 2025to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

67 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

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

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

67 sites in 10 countries

United States20 sites, 20 recruiting

  • World Research Link

    Baytown, Texas, 77521

    833-832-8328

    Amir Rasheed

    Recruiting

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

    704-342-1900

    Justin Favaro

    Recruiting

  • UCHealth Harmony

    Fort Collins, Colorado, 80528

    970-297-6150

    Steven Schuster

    Recruiting

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104

    817-702-8049

    Kalyani Narra

    Recruiting

  • Marin Cancer Care

    Greenbrae, California, 94904

    Cyrus Mazidi

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    630-560-0121

    Srilata Gundala

    Recruiting

  • Kelsey-Seybold Clinic

    Houston, Texas, 77025

    Tri Vu

    Recruiting

  • Southern Oncology Specialists

    Huntersville, North Carolina, 28078

    William Mitchell

    Recruiting

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Tarah Ballinger

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

    714-252-9415

    Sudarsan Kollimuttathuillam

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Nihal Abdulla

    Recruiting

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504

    541-789-5003

    Alison Savage

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

    Olivia Seecof

    Recruiting

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

    801-689-3909

    Carl Gray

    Recruiting

  • Summit Cancer Care, PC

    Savannah, Georgia, 31405

    912-651-5771

    Michael Chahin

    Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

    631-675-5075

    Richard Zuniga

    Not yet recruiting

  • Cancer Care Northwest

    Spokane, Washington, 99202

    Saritha Thumma

    Recruiting

  • BRCR Global - Tamarac

    Tamarac, Florida, 33321

    Andrew Schneider

    Recruiting

  • North Mississippi Hematology and Oncology Associates

    Tupelo, Mississippi, 38801

    Amit Jain

    Recruiting

  • BASS Cancer Center

    Walnut Creek, California, 94598

    Jewel Johl

    Recruiting

Other trials in United States

Turkey (Türkiye)9 sites, 9 recruiting

  • Adana Medical Park Seyhan Hastanesi

    Adana, 01140

    905056166338

    Ahmet Taner Sumbul

    Recruiting

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800

    905555306271

    Mehmet Ali Nahit Sendur

    Recruiting

  • Antalya Egitim ve Arastırma Hastanesi

    Antalya, 07100

    905336488217

    Derya KIVRAK SALIM

    Recruiting

  • Ege Universitesi Hastanesi

    Bornova, 35100

    05322202675

    Tuncay Goksel

    Not yet recruiting

  • Trakya University

    Edirne, 22030

    90 5334364678

    Muhammet Hacioglu

    Recruiting

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

    05065118207

    tulay kus

    Recruiting

  • T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi

    Pendik, 34899

    905323233799

    Ibrahim Bayoglu

    Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100

    +90 5054785576

    Ilhan Hacibekiroglu

    Recruiting

  • Dicle Üniversitesi

    Sur, 21280

    90 5337677131

    Muhammet kaplan

    Recruiting

Other trials in Turkey (Türkiye)

Spain7 sites, 2 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Completed

  • FutureMeds - Madrid

    Madrid, 28003

    Esther Holgado

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

    Silvia Garcia Adrian

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Active, not recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Active, not recruiting

  • Hospital de Mataró

    Mataró, 08304

    Completed

  • Hospital Universitari Sant Joan de Reus

    Reus, 43204

    Active, not recruiting

Other trials in Spain

Australia5 sites, 5 recruiting

  • Ballarat Health Services

    Ballarat Central, 3350

    Sharad Sharma

    Recruiting

  • Bendigo Health Care Group

    Bendigo, 3550

    Danielle Forbes

    Recruiting

  • WA Country Health Service Trial Centre

    Perth, 6102

    Wei-Sen Lam

    Recruiting

  • Goulburn Valley Health

    Shepparton, 3630

    61358323777

    Myron Klevansky

    Recruiting

  • Latrobe Regional Health

    Traralgon, 3844

    Quan Tran

    Recruiting

Other trials in Australia

China5 sites, 5 recruiting

  • The First People's Hospital of Changde City

    Changde, 415003

    Tao Wu

    Recruiting

  • Zhujiang Hospital

    Guangzhou, 510280

    13380091897

    Xigang Hu

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014

    Liu Yang

    Recruiting

  • Jiangmen Center Hospital

    Jiangmen

    18933183766

    XIAOPING LI

    Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, 471003

    Jun Yao

    Recruiting

Other trials in China

Romania5 sites, 5 recruiting

  • SC Memorial Healthcare International SRL

    Bucharest, 013812

    40721298677

    Ingrid Iordan

    Recruiting

  • Spitalul Clinic Colentina

    Bucharest, 020125

    Andrei Popescu

    Recruiting

  • Spitalul Clinic Colțea

    Bucharest, 030171

    Ileana-Raluca Patru

    Recruiting

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, 200542

    40727774974

    Michael Schenker

    Recruiting

  • Ovidius Clinical Hospital OCH

    Ovidiu, 905900

    0724877013

    Laura Mazilu

    Recruiting

Other trials in Romania

Taiwan5 sites, 5 recruiting

  • E-Da Cancer Hospital

    Kaohsiung City, 82445

    886-7-6150022

    Kun-Ming Rau

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    0912777918

    Chun-Hui Lee

    Recruiting

  • Chi Mei Hospital - Liouying Branch

    Tainan, 73657

    Wen-Tsung Huang

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Muh-Hwa Yang

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Chia-Hsun Hsieh

    Recruiting

Other trials in Taiwan

Italy4 sites, 4 recruiting

  • Aou Ospedali Riuniti Umberto I

    Ancona, 60126

    0715965715

    Rossana Berardi

    Recruiting

  • Azienda Ospedaliero Universitaria

    Modena, 41125

    Maria Vitale

    Recruiting

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

    Luca Galli

    Recruiting

  • AULSS8 Berica-Ospedale S.Bortolo

    Vicenza, 36100

    +39 0444753906

    Maria Vittoria Resi

    Recruiting

Other trials in Italy

Japan4 sites, 4 recruiting

  • Himeji Medical Center

    Himeji, 670-8520

    81120023812

    Tetsuji Kawamura

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

    81120023812

    Naoki Fukuda

    Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    81120023812

    TAKAKO NAKAJIMA

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho,Sunto-gun, 411-8777

    81120023812

    Tateaki Naito

    Recruiting

Other trials in Japan

France3 sites, 1 recruiting

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, 84918

    Active, not recruiting

  • Centre Hospitalier d'Annecy

    Epagny Metz-Tessy, 74370

    334 26 55 67 52

    Melodie Carbonnaux

    Recruiting

  • Clinique Victor Hugo Le Mans

    Le Mans, 72000

    Active, not recruiting

Other trials in France

About this study

Official 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

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.

Being tested
LY3537021, Placebo, Standard of Care Antiemetic Therapies, Background Chemotherapy
Keywords
Chemotherapy-Induced Nausea and Vomiting (CINV), Anthracycline and cyclophosphamide (AC), Glucose-dependent Insulinotropic Peptide (GIP), Incretins, Cisplatin
Medical subject headings
Nausea, Vomiting, Drug-Related Side Effects and Adverse Reactions, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3537021Drug

    Administered SC

  • PlaceboDrug

    Administered SC

  • Standard of Care Antiemetic TherapiesDrug

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

  • Background ChemotherapyDrug

    Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV

Study groups in NCT07169851
Study groupRoleWhat they receive
LY3537021 + Antiemetic TherapiesExperimentalPrior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
Receives: Drug: LY3537021; Drug: Standard of Care Antiemetic Therapies; Drug: Background Chemotherapy
Placebo + Antiemetic TherapiesPlacebo comparatorPrior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
Receives: Drug: Placebo; Drug: Standard of Care Antiemetic Therapies; Drug: Background Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    CR defined as no vomiting and no rescue medication

    Measured: 24 to 120 hours after first chemotherapy infusion

Secondary outcomes (4)

  1. Proportion of Participants with a CR to CINV

    CR defined as no vomiting and no rescue medication

    Measured: Zero to 120 hours after the first chemotherapy infusion

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

    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.

    Measured: Zero to 120 hours after the first chemotherapy infusion

  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

    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.

    Measured: Zero to 120 hours after the first chemotherapy infusion

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2025
  2. Study start28 Nov 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07169851
Sponsor's protocol ID
27402
Other IDs
2025-522204-24-00, J2R-MC-YAAD, U1111-1322-9151, 2025
Status last verified
Nov 2026
First submitted
5 Sep 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3537021 and Background Chemotherapy in people with Nausea and Vomiting, run by Eli Lilly and Company at 67 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Turkey (Türkiye), Spain, Australia, China and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07169851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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