← Trials/Trial dossier/NCT05110794

CompletedPhase 1Results posted

A Multiple-Dose Study of LY3502970 in Healthy Participants

A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

34

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18.5-35Healthy volunteers

Primary endpoints

PK: Maximum Observed Concentration (Cmax) of LY3502970PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24)Cmax (Tmax) 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 IDNCT05110794
Org study ID18277
Secondary IDJ2A-MC-GZGJEli Lilly and Company

Timeline

Milestones

Study start2021-11-05actual
Study first posted2021-11-08actual
Primary completion2022-02-10actual
Study completion2022-02-10actual
Last update posted2026-05-26actual
Results first posted2026-05-26actual

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 with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Exclusion criteria

Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. 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. 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. 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

PK: Maximum Observed Concentration (Cmax) of LY3502970

Time frame:PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanograms per milliliter (ng/mL)95% CI
16 mg LY3502970 (Fasted)80.5
16 mg LY3502970 (Fed)67.5
Primary/registry result

PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970

Time frame:PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*hour(h)/mL95% CI
16 mg LY3502970 (Fasted)1200
16 mg LY3502970 (Fed)1050
Primary/registry result

Time to Maximum Observed Concentration (Tmax) of LY3502970

Time frame:PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

time to event, event

Posted result

GroupValue (median), hour95% CI
16 mg LY3502970 (Fasted)8.04.00 – 16.00
16 mg LY3502970 (Fed)8.004.00 – 24.00
Primary/protocol endpoint

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

Time frame:Predose up to 41 days postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of LY3502970

Time frame:Predose up to 41 days postdose

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Predose up to 41 days postdose

Tmax

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.