A Phase 2 interventional study of LY3537021 and Placebo in Nausea, Vomiting and Drug-Related Side Effects and Adverse Reactions, sponsored by Eli Lilly and Company. Recruiting at 67 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 204 is above the median of 96 across 544 interventional studies indexed under Nausea.
Browse Nausea studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label
Drug: LY3537021 · Drug: Standard of Care Antiemetic Therapies · Drug: Background Chemotherapy
Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label
Drug: Placebo · Drug: Standard of Care Antiemetic Therapies · Drug: Background Chemotherapy
Administered SC
Administered SC
5-HT3 Receptor Antagonist, NK1 Receptor Antagonist, Dexamethasone administered orally, IV, or transdermally
Cisplatin or anthraxyline and cyclophosphamide (AC) administered IV
Proportion of Participants with a Complete Response (CR) in the Delayed Phase of CINV
CR defined as no vomiting and no rescue medication
Time frame: 24 to 120 hours after first chemotherapy infusion
Proportion of Participants with a CR to CINV
CR defined as no vomiting and no rescue medication
Time frame: 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.
Time frame: 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.
Time frame: Zero to 120 hours after the first chemotherapy infusion
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)
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Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 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.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: GIPR Agonist LY3537021