CompletedPhase 1

A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants

A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18.5-35•Healthy volunteers

Primary endpoints

•AUC•PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last•PK: Maximum Observed Concentration (Cmax) of Orforglipron

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 IDNCT06370728

Org study ID18621

Secondary IDJ2A-MC-GZPJEli Lilly and Company

Timeline

Milestones

Study first posted2024-04-17actual

Study start2024-05-06actual

Primary completion2024-07-23actual

Study completion2024-07-23actual

Last update posted2024-07-26actual

Assets

Investigational agents

Orforglipron

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age21 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).

•Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.

•Have a hemoglobin level of

-at least 11.4 g/dL for individuals assigned female at birth (AFAB) and

-at least 12.5 g/dL for AMAB.

•Have venous access sufficient to allow for blood sampling.

Exclusion criteria

•Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.

•Have an abnormal 12-lead electrocardiogram (ECG).

•Have human leucocyte antigen-B (HLA-B)*1502 or HLA-A*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.

•Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.

•Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.

Endpoints (3)

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

3 endpoints

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron

Time frame:Predose up to Day 18

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint/low confidence

PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron

Time frame:Predose up to Day 18

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Concentration (Cmax) of Orforglipron

Time frame:Predose up to Day 18

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.