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Drug interaction study reveals how carbamazepine may alter orforglipron exposure

NCT ID NCT06370728

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study examines whether carbamazepine, a common medication, changes how the body absorbs and clears orforglipron. Healthy volunteers receive orforglipron alone and then with carbamazepine to compare drug levels in the blood. The goal is to understand if dose adjustments are needed when these drugs are taken together.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
orforglipron and carbamazepine
What this could lead to
If successful, this study could help determine whether orforglipron doses need adjustment when taken with carbamazepine.
What could go wrong
This is an early-phase drug interaction study in healthy volunteers, not a treatment trial. Results may not predict effects in patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

May 2024

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • ICON Early Phase Services

    San Antonio, Texas, 78209, United States

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