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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

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

26

Study population

Healthy volunteers

Eligibility highlights

•BMI 18.5-35•Healthy volunteers

Primary endpoints

•Part•Part B•Cmax of LY3502970

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Who this study enrolls

Healthy volunteers

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

Group	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

Group	Geometric mean · nanogramhours per milliliter (ngh/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

Group	Median · hours	95% CI
Part A (LY3502970)16 mg reference capsule (Day 24)	7.02	4 - 8
16 mg prototype 1 tablet (Days 30 and 36)	8	4 - 16
16 mg prototype 2 tablet (Days 30 and 36)	8	4 - 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

Group	Geometric mean · ng/mL	95% 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

Group	Geometric mean · ng*h/mL	95% 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

Group	Median · hours	95% CI
Part B16 mg prototype 2 tablet (Fasted) (Day 24)	8.00	4.00 - 12.00
16 mg prototype 2 tablet (Fed) (Day 30)	7.00	2.00 - 16.05
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)	7.00	4.00 - 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 6, 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 6, 2026 snapshot.