A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants

Launched by ELI LILLY AND COMPANY · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Orforglipron to understand how it behaves in the body when taken as a single capsule versus multiple capsules. The researchers want to find out how much of the medicine gets into the bloodstream and how long it takes for the body to eliminate it, both after eating and on an empty stomach. The study will last about 21 weeks and aims to ensure the safety and tolerability of the drug by monitoring any side effects participants may experience.

To be eligible for this study, participants should be healthy adults aged 18 to 55 with a stable body weight and a body mass index (BMI) between 23.0 and 35.0. They will need to pass certain health tests and be willing to follow the study guidelines. Participants can expect to take either one capsule or multiple capsules of the medication and will have regular check-ins to monitor their health. It’s important to note that individuals with specific health conditions, like certain mental health disorders or issues with swallowing capsules, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m²), inclusive
• • Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
• • Have venous access sufficient to allow for blood sampling
• • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Exclusion Criteria:
• • Have a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%
• • Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m²)
• • Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the 2 years prior to screening
• • Actively suicidal and therefore deemed to be at significant risk for suicide
• • Have a known clinically significant gastric emptying abnormality
• • Have history or presence of acute or chronic pancreatitis or an elevation in serum lipase or amylase levels greater than 3 times the upper limit of normal (ULN)
• • Have an abnormal blood pressure (BP), pulse rate, or both
• • Have difficulty swallowing capsules