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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06692348

J2A-JE-GZPM (Other Identifier)

27228

Details and patient eligibility

About

The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Orforglipron

Experimental group

Description:

Participants will receive different sequences of Orforglipron doses administered as either single capsule or multiple capsules at different dose levels under either fasted or fed condition.

Treatment:

Drug: Orforglipron