A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants

18449

The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.

2022-08-08

2023-02-24

2023-02-24

Completed

Early phase I

47

Inclusion Criteria: * Participants who are overtly healthy as determined through medical evaluation * Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²) * Males, or females who are not of childbearing potential. * Capable of giving signed informed consent form * Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine) Exclusion Criteria: * Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs * History of malignancy within 5 years prior to screening * Have evidence of significant active psychiatric disorder(s) * Have undergone any form of bariatric surgery * Have an abnormality in the 12-lead electrocardiogram (ECG) * Are females who are lactating

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study has two parts. Part A is parallel model and part B is crossover.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 47, 'type': 'ACTUAL'}}

2023-03-01