A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants. Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 48 weeks excluding a screening period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 65
Healthy Volunteers: t
View:
• Have a BMI within the range of:
‣ Parts A and D: 27.0 to 45.0 kilogram per square meter (kg/m²)
⁃ Parts B and C: 22.0 to 26.9 kg/m²
• Parts B and C: Weigh 60 kg (80 lbs) or more at screening
• Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
• Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.
Locations
United States
California
Collaborative Neuroscience Research, LLC
RECRUITING
Los Alamitos
Florida
Fortrea Clinical Research Unit
COMPLETED
Daytona Beach
Clinical Pharmacology of Miami
RECRUITING
Miami
Missouri
QPS
RECRUITING
Springfield
Texas
Fortrea Clinical Research Unit
COMPLETED
Dallas
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date:2024-09-05
Estimated Completion Date:2026-07
Participants
Target number of participants:302
Treatments
Experimental: LY3537031 Part A (Cohorts 1-7)
Multiple-ascending doses of LY3537031 administered subcutaneously (SC)
Placebo_comparator: Placebo Part A
Placebo administered SC
Experimental: LY3537031 Part B (Cohorts 8-11)
Multiple-ascending doses of LY3537031 administered SC
Placebo_comparator: Placebo Part B
Placebo administered SC
Experimental: LY3537031 Part C (Cohorts 12-15)
Multiple-ascending doses of LY3537031 administered SC
Placebo_comparator: Placebo Part C
Placebo administered SC
Experimental: LY3537031 Part D (Cohorts 16-19)
Multiple-ascending doses of LY3537031 administered SC