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.
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
- Conditions the study is for
- Nausea, Vomiting, Drug-Related Side Effects and Adverse Reactions
- What is being tested?
- LY3537021 and Background Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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
Physicians interested in becoming principal investigators please contact contact
67 sites in 10 countries
United States20 sites, 20 recruiting
- 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
- Not yet recruiting
New York Cancer and Blood Specialists
Shirley, New York, 11967
631-675-5075
Richard Zuniga
- Recruiting
Cancer Care Northwest
Spokane, Washington, 99202
Saritha Thumma
- Recruiting
BRCR Global - Tamarac
Tamarac, Florida, 33321
561-477-0614
Chintan Gandhi
- Recruiting
North Mississippi Hematology and Oncology Associates
Tupelo, Mississippi, 38801
Amit Jain
- Recruiting
BASS Cancer Center
Walnut Creek, California, 94598
Jewel Johl
Turkey (Türkiye)9 sites, 9 recruiting
- 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
- Not yet recruiting
Ege Universitesi Hastanesi
Bornova, 35100
05322202675
Tuncay Goksel
- 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
Spain7 sites, 7 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
+34 93 556 56 38
Margarita Majem Tarruella
- Recruiting
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
606827688
Imanol Martinez Salas
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
951032267
Jose Carlos Benitez Montañez
- Recruiting
Hospital de Mataró
Mataró, 08304
Laura Punti Brun
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43204
Kepa Amillano Parraga
Australia5 sites, 5 recruiting
- 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
China5 sites, 5 recruiting
- 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
Romania5 sites, 5 recruiting
- 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
Taiwan5 sites, 5 recruiting
- 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
Italy4 sites, 4 recruiting
- 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
Japan4 sites, 4 recruiting
- 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
France3 sites, 3 recruiting
- Recruiting
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918
490276857
Alma Stancu
- 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
+33243297908
Yoann Pointreau
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 group | Role | What they receive |
|---|---|---|
| LY3537021 + Antiemetic Therapies | Experimental | Prior 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 Therapies | Placebo comparator | Prior 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.
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)
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
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
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
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.
- First posted12 Sep 2025
- Study start28 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
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
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 8 Oct 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.