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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07169851




Registration number
NCT07169851
Ethics application status
Date submitted
5/09/2025
Date registered
12/09/2025
Date last updated
12/09/2025

Titles & IDs
Public title
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Scientific 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
Secondary ID [1] 0 0
2025-522204-24-00
Secondary ID [2] 0 0
27402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nausea 0 0
Vomiting 0 0
Drug-Related Side Effects and Adverse Reactions 0 0
Neoplasms 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3537021
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of Care Antiemetic Therapies
Treatment: Drugs - Background Chemotherapy

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


Treatment: Drugs: LY3537021
Administered SC

Treatment: Drugs: Placebo
Administered SC

Treatment: Drugs: Standard of Care Antiemetic Therapies
5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally

Treatment: Drugs: Background Chemotherapy
Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV
Timepoint [1] 0 0
24 to 120 hours after first chemotherapy infusion
Secondary outcome [1] 0 0
Proportion of Participants with a CR to CINV
Timepoint [1] 0 0
Zero to 120 hours after the first chemotherapy infusion
Secondary outcome [2] 0 0
Proportion of Participants with a Response of 0 in the Nausea Item of the Vomiting and Nausea Diary and No Rescue Medication
Timepoint [2] 0 0
Zero to 120 hours after the first chemotherapy infusion
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Zero to 120 hours after the first chemotherapy infusion
Secondary outcome [4] 0 0
Pharmacokinetics (PK) Trough Concentrations (Ctrough) of LY3537021
Timepoint [4] 0 0
From Day 1 of Cycle 1 until Day 1 of Cycle 2 (each cycle is expected to be 14, 21 or 28 days)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bendigo Health Care Group - Bendigo
Recruitment hospital [2] 0 0
WA Country Health Service Trial Centre - Perth
Recruitment hospital [3] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [4] 0 0
Latrobe Regional Health - Traralgon
Recruitment postcode(s) [1] 0 0
3550 - Bendigo
Recruitment postcode(s) [2] 0 0
6102 - Perth
Recruitment postcode(s) [3] 0 0
3630 - Shepparton
Recruitment postcode(s) [4] 0 0
3844 - Traralgon
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Mississippi
Country [7] 0 0
United States of America
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New York
Country [8] 0 0
United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
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China
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Changde
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China
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Guangzhou
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China
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Hangzhou
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China
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Jiangmen
Country [18] 0 0
China
State/province [18] 0 0
Luoyang
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France
State/province [19] 0 0
Avignon
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France
State/province [20] 0 0
Epagny Metz-Tessy
Country [21] 0 0
France
State/province [21] 0 0
Le Mans
Country [22] 0 0
France
State/province [22] 0 0
Lyon Cedex08
Country [23] 0 0
Italy
State/province [23] 0 0
Ancona
Country [24] 0 0
Italy
State/province [24] 0 0
Modena
Country [25] 0 0
Italy
State/province [25] 0 0
Pisa
Country [26] 0 0
Italy
State/province [26] 0 0
Vicenza
Country [27] 0 0
Japan
State/province [27] 0 0
Himeji
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Japan
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Kotoku
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Japan
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Kyoto
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Ovidiu
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Mataró
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Spain
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Málaga
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Spain
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Reus
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Taiwan
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Kaohsiung City
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Taiwan
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Tainan City
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Taiwan
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Taipei
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Taiwan
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Taoyuan District
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Turkey (Türkiye)
State/province [42] 0 0
Adana
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Turkey (Türkiye)
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Adapazari
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Turkey (Türkiye)
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Ankara
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Turkey (Türkiye)
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Antalya
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Turkey (Türkiye)
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Bornova
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Turkey (Türkiye)
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Diyarbakir
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Turkey (Türkiye)
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Edirne
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Turkey (Türkiye)
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Gaziantep
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Turkey (Türkiye)
State/province [50] 0 0
Pendik

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07169851