Healthy
Conditions
Brief summary
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The study has two parts. Part A is parallel model and part B is crossover.
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Week 22 | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
Countries
Singapore
Outcome results
None listed