← Trials/Trial dossier/NCT05051566

CompletedPhase 1Results posted

A Multiple Dose Study of LY3502970 in Healthy Participants

A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

26

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18.5-35Healthy volunteers

Primary endpoints

PartPart BCmax of LY3502970

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 IDNCT05051566
Org study ID17783
Secondary ID2020-005750-15
Secondary IDJ2A-MC-GZGDEli Lilly and Company
Secondary IDQSC202755Quotient Sciences

Timeline

Milestones

Study start2021-09-16actual
Study first posted2021-09-21actual
Primary completion2022-04-04actual
Study completion2022-04-04actual
Last update posted2026-05-29actual
Results first posted2026-05-29actual

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

Are overtly healthy as determined by medical evaluation.
Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).

Exclusion criteria

Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2X ULN (Upper Limit of Normal)
Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Are women of child-bearing potential
Are women who are lactating

Endpoints (9)

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

9 endpoints
Primary/registry result

Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanograms per milliliter (ng/mL)95% CI
Part A (LY3502970)16 mg reference capsule (Day 24)66.2
16 mg prototype 1 tablet (Days 30 and 36)111
16 mg prototype 2 tablet (Days 30 and 36)97.4
Primary/registry result

Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hours per milliliter (ng*h/mL)95% CI
Part A (LY3502970)16 mg reference capsule (Day 24)988
16 mg prototype 1 tablet (Days 30 and 36)1480
16 mg prototype 2 tablet (Days 30 and 36)1400
Primary/registry result

Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

concentration, descriptive

Posted result

GroupValue (median), hours95% CI
Part A (LY3502970)16 mg reference capsule (Day 24)7.024 – 8
16 mg prototype 1 tablet (Days 30 and 36)84 – 16
16 mg prototype 2 tablet (Days 30 and 36)84 – 16
Primary/registry result

Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
Part B16 mg prototype 2 tablet (Fasted) (Day 24)63.4
16 mg prototype 2 tablet (Fed) (Day 30)56.3
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)59.6
Primary/registry result

Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/mL95% CI
Part B16 mg prototype 2 tablet (Fasted) (Day 24)903
16 mg prototype 2 tablet (Fed) (Day 30)865
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)956
Primary/registry result

Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation

Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

concentration, descriptive

Posted result

GroupValue (median), hours95% CI
Part B16 mg prototype 2 tablet (Fasted) (Day 24)8.004.00 – 12.00
16 mg prototype 2 tablet (Fed) (Day 30)7.002.00 – 16.05
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)7.004.00 – 12.00
Primary/protocol endpoint

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

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Predose up to 24 hours postdose

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.