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CompletedPhase 1Results posted

A Study of Two Different Formulations of LY3502970 in Healthy Participants

A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

39

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18.5-35Healthy volunteers

Primary endpoints

Cmax of LY3502970 in Formulation 1 and Formulation 2PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 HoursPK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1

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 IDNCT05341089
Org study ID17785
Secondary IDJ2A-MC-GZGHEli Lilly and Company

Timeline

Milestones

Study first posted2022-04-22actual
Study start2022-05-17actual
Primary completion2022-09-01actual
Study completion2022-09-01actual
Last update posted2026-05-27actual
Results first posted2026-05-27actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age21 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Are overtly healthy as determined by medical evaluation
Participants who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)
Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion criteria

Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening
Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening
Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing
Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. A negative test within 6 months of screening would not need to be repeated.
Participants who show evidence of hepatitis C and/or positive hepatitis C antibody, or both. A negative test within 6 months of screening would not need to be repeated.
Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody, or all. A negative test within 6 months of screening would not need to be repeated.

Endpoints (6)

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

6 endpoints
Primary/registry result

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2

Time frame:Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram per milliliter (ng/mL)95% CI
16 mg LY3502970 (Formulation 1)86.5
16 mg LY3502970 (Formulation 2)86.5
Primary/registry result

PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2

Time frame:Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanogram*hour per milliliter (ng*h/mL)95% CI
16 mg LY3502970 (Formulation 1)1260
16 mg LY3502970 (Formulation 2)1240
Primary/registry result

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2

Time frame:Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

time to event, event

Posted result

GroupValue (median), Hours (h)95% CI
16 mg LY3502970 (Formulation 1)6.004.00 – 23.92
16 mg LY3502970 (Formulation 2)6.002.00 – 12.00
Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

Time frame:Pre-dose on Day 1 up to 39 days post-dose

Cmax

concentration, descriptive

Primary/protocol endpoint/low confidence

PK: Area Under the Plasma Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LY3502970

Time frame:Pre-dose on Day 1 up to 39 days post-dose

concentration, descriptive

Primary/protocol endpoint

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970

Time frame:Pre-dose on Day 1 up to 39 days post-dose

Tmax

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.