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A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants (J2A-JE-GZPM)

A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants (J2A-JE-GZPM)

Wakayama Naohiko

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Complete

Dec. 13, 2024

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

crossover assignment

treatment purpose

- 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

- 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

Both

Healthy

DRUG: Orforglipron(Other Name: LY3502970)
Administered orally

[Study Arms]
Experimental: Orforglipron
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.
Interventions:
Drug: Orforglipron

Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)
[ Time Frame: Week 3 Through Week 16 ]
PK: Steady-state AUC of Orforglipron (Fasted State)

+81-6-6395-9000

Nov. 22, 2024

No

none