DelfaGLP-1 Atlas

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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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30

actual

Study population

Healthy volunteers

Key I/E criteria

•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

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 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

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

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 1, 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 1, 2026 snapshot.