A Study of LY3537031 in Overweight, Obese, and Healthy Participants

Launched by ELI LILLY AND COMPANY · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LY3537031 to see how safe it is and how well it works for different groups of people, including those who are overweight, obese, or healthy. The study has three parts: the first part focuses on overweight and obese participants, while the second and third parts involve healthy participants, with the third part specifically including healthy individuals from Japan and China. Over about 20 weeks, researchers will conduct blood tests to understand how the drug moves through the body and how it affects body weight.

To participate, individuals need to meet certain criteria. For example, overweight participants should have a body mass index (BMI) between 27.0 and 45.0, while healthy participants should have a BMI between 22.0 and 26.9 and weigh at least 60 kg (about 132 pounds). Participants should also report no significant weight changes in the last three months. However, people with a history of certain weight-loss surgeries, those who are pregnant or breastfeeding, or those taking weight-loss medications recently won't be eligible. Throughout the study, participants can expect regular check-ins and assessments to monitor their health and the effects of the medication.

Gender

ALL

Eligibility 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))