Current partner codePEPTIDESDE
NCT06370728·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

30

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.

Interventions

Treatment arms and agents.

DRUG

Orforglipron

Administered orally

DRUG

Carbamazepine

Administered orally

Timeline

From registration to results.

  1. First posted

    Apr 17, 2024

  2. Study start

    May 6, 2024

  3. Primary completion

    Jul 23, 2024

  4. Study completion

    Jul 23, 2024

  5. Results posted

    Jul 17, 2026

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)

PK: AUC (0-∞) of Orforglipron

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

Time frame · Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)

PK: AUC (0-tlast) of Orforglipron

PK: Maximum Observed Concentration (Cmax) of Orforglipron

Time frame · Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)

PK: Cmax of Orforglipron

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
21 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

ICON Early Phase Services

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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