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CompletedPhase 1Results posted

A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

A Phase 1, Open-label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants

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

AUCPK: Area Under the Concentration Time Curve From Time Zero to Time TPK: Maximum Observed Concentration (Cmax) 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 IDNCT05469126
Org study ID18507
Secondary IDJ2A-MC-GZGMEli Lilly and Company

Timeline

Milestones

Study first posted2022-07-21actual
Study start2022-08-01actual
Primary completion2022-11-03actual
Study completion2022-11-03actual
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

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

Exclusion criteria

Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Participants who regularly use known drugs of abuse
Women who are lactating and who are of child-bearing potential
Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Endpoints (5)

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

5 endpoints
Primary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970

Time frame:Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose

concentration, descriptive

Posted result

GroupValue (geometric_least_squares_mean), nanogram*hour per milliliter (ng*hr/mL)95% CI
LY3502970 (Day 1)380
Clarithromycin + LY3502970 (Day 21)1380
Geometric LS Mean Ratio3.5490% CI2.964.22
Primary/registry result

PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970

Time frame:Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose

concentration, descriptive

Posted result

GroupValue (geometric_least_squares_mean), ng*h/ mL95% CI
LY3502970 (Day 1)333
Clarithromycin + LY3502970 (Day 21)1270
Geometric LS Mean Ratio3.6990% CI3.194.28
Primary/registry result

PK: Maximum Observed Concentration (Cmax) of LY3502970

Time frame:Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose

concentration, descriptive

Posted result

GroupValue (geometric_least_squares_mean), nanograms per milliliter (ng/mL)95% CI
LY3502970 (Day 1)15.4
Clarithromycin + LY3502970 (Day 21)30.4
Geometric LS Mean Ratio1.8890% CI1.612.19
Primary/protocol endpoint

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

Time frame:Predose up to 120 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Concentration (Cmax) of LY3502970

Time frame:Predose up to 120 hours postdose

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 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.