← Trials/Trial dossier/NCT06692348

CompletedPhase 1

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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

3

Recruiting sites

Enrollment

86

actual

Study population

Healthy volunteers

Key I/E criterion

BMI 23-35

Primary endpoints

Steady-state AUC of Orforglipron (Fasted State)PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)PK: Steady-state AUC of Orforglipron (Fed State)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06692348
Org study ID27228
Secondary IDJ2A-JE-GZPMEli Lilly and Company

Timeline

Milestones

Study first posted2024-11-18actual
Study start2024-12-13actual
Primary completion2025-06-09actual
Study completion2025-06-09actual
Last update posted2025-06-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)

Time frame:Week 3 Through Week 16

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)

Time frame:Week 3 Through Week 16

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Steady-state AUC of Orforglipron (Fed State)

Time frame:Week 3 Through Week 16

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Steady-state Cmax of Orforglipron (Fed State)

Time frame:Week 3 Through Week 16

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.