Evaluating LY3537031 in overweight, obese, and healthy individuals
A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers
This study is testing a new drug called LY3537031 to see how safe it is and how well it works in overweight, obese, and healthy people, including those from Japan and China.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 5 sites (Los Alamitos, California and 4 other locations) |
| Trial ID | NCT06606106 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and tolerability of the drug LY3537031 across three parts. Part A focuses on overweight and obese participants, while Parts B and C involve healthy participants, with Part C specifically including Japanese and Chinese individuals. Participants will undergo blood tests to assess how the drug is absorbed and eliminated by the body, and body weight will be monitored throughout the study, which lasts approximately 48 weeks excluding the screening period.
Who should consider this trial
Good fit: Ideal candidates include overweight or obese individuals with a BMI between 27.0 to 45.0 kg/m², as well as healthy individuals with a BMI between 22.0 to 26.9 kg/m².
Not a fit: Patients who have undergone bariatric surgery or are currently lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for managing obesity and related conditions.
How similar studies have performed: While this approach is not widely tested, similar studies evaluating drug safety and tolerability in diverse populations have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a BMI within the range of: * Part A: 27.0 to 45.0 kilogram per square meter (kg/m²) * Part B: 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. Exclusion Criteria: * Have undergone any form of bariatric surgery * Participants who are lactating * Have taken medications that promote weight loss within 90 days before screening * Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL))
Where this trial is running
Los Alamitos, California and 4 other locations
- Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States (Recruiting)
- Fortrea Clinical Research Unit — Daytona Beach, Florida, United States (Active_not_recruiting)
- Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)
- Qps — Springfield, Missouri, United States (Recruiting)
- Fortrea Clinical Research Unit — Dallas, Texas, United States (Active_not_recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.