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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051240196
Enrollment
80
Registered
2024-11-26
Start date
2024-12-13
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Interventions

DRUG: Orforglipron(Other Name: LY3502970) Administered orally [Study Arms] Experimental: Orforglipron Participants will receive different sequences of Orforglipron doses administered as either si

Sponsors

Wakayama Naohiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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)

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026