PIPELINE > TRIAL OVERVIEW

Long-acting GIP Receptor Agonist
LY3537021
Phase
2
Active, not recruiting
A Phase 2 Study to Test LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancera

LAGIPRA
Key Inclusion Criteria
  • Have confirmed histological or cytological diagnosis of malignant disease
  • Are scheduled to receive anthracycline and cyclophosphamide (AC) or cisplatin-based chemotherapy at a dose of ≥70 mg/m² on Day 1 of each cycle
  • Have a life expectancy of more than 6 months
  • Have an Eastern Cooperative Oncology Group performance status of 0 to 2
  • Able to receive a 5-hydroxytryptamine subtype 3 (5-HT3) receptor antagonist, a neurokinin-1 (NK-1) receptor antagonist, and dexamethasone for chemotherapy-induced nausea and vomiting (CINV) according to National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2025 for CINV (NCCN 2025)
  • Have adequate hematologic and organ function to receive treatment with a cisplatin-based or AC regimen, as per applicable guidelines and the investigator’s judgment
  • Have adequate liver, renal, and pancreatic laboratory parameters as defined in the protocol
Key Exclusion Criteria
  • Have central nervous system metastases
  • Have known hypersensitivity or contraindications to 5-HT3 receptor antagonists, NK-1 receptor antagonists, or dexamethasone
  • Have an established diagnosis of uncontrolled diabetes mellitus, defined as HbA1c ≥8% or have experienced a severe hypoglycemic event in the last 3 months
  • Have a history of, or current signs of, a significant cardiac condition that increases study risks or may interfere with electrocardiogram data analysis, including any QT interval/corrected QT interval using Fridericia's formula-related conditions
  • Have a history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. Symptoms of thyroid tumors include neck mass, difficulty swallowing or breathing, persistent hoarseness, and elevated calcitonin levels above 35 ng/L, along with abnormal thyroid-stimulating hormone levels
  • Have known active hepatitis B, hepatitis C, untreated human immunodeficiency virus (HIV), or cytomegalovirus (CMV) infection
  • Have a significant history of or current medical disorder, or a history of anticipatory nausea and vomiting, or hypercalcemia
  • Are scheduled to receive bone marrow transplantation or stem cell rescue therapy, or planned major surgery
  • Have known contraindications or allergies to glucose-dependent insulinotropic polypeptide (GIP) analogs or related compounds, or a historical disposition to develop allergic diseases
  • Have a plan to receive prior/concomitant therapy
  • Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention
a
This clinical trial is being conducted globally.
b
Stratified by gender and type of chemotherapy regimen (cisplatin or AC).
c
During the first cycle of treatment.
For information on trial enrollment, locations, and more, call 1-800-545-5979.