Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT06370728Other id18621Other idJ2A-MC-GZPJ

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 30 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 6 May 2024
Primary completion: 23 Jul 2024
Completion: 23 Jul 2024
First posted: 17 Apr 2024
Last update posted: 17 Jul 2026
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20242025

Ph 1
A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants
NCT06370728
6 May 2024 to 23 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

OrforglipronDrug
CarbamazepineDrug

Arms1

Experimental
Orforglipron + Carbamazepine
Participants received study intervention through oral administration as follows: * Day 1: 1 milligram (mg) orforglipron capsule alone * Days 6 to 8: Twice daily (BID) doses of 100 mg carbamazepine tablets * Days 9 to 11: BID doses of 200 mg carbamazepine tablets * Days 12 to 14: BID doses of 300 mg carbamazepine tablets * Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets * Days 16 to 18: BID doses of 300 mg carbamazepine tablets

Primary outcomes3

Outcomes the sponsor listed as primary.

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)
Registry description
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)
Registry description
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)
Registry description
PK: Cmax of Orforglipron

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 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)

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

Group	Value (nanogramshours per milliliter(ngh/mL))	Spread
Orforglipron + Carbamazepine	104	26.6

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

Group	Value (nanogramshours per milliliter(ngh/mL))	Spread
Orforglipron + Carbamazepine	93.4	24.6

Primary outcomeGeometric mean· 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: Maximum Observed Concentration (Cmax) of Orforglipron

Group	Value (nanograms per milliliter (ng/mL))	Spread
Orforglipron + Carbamazepine	4.97	31.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Orforglipron Alone (Days 1-5)Participants observed for adverse events during Orforglipron alone on Day 1 and post-dose observation period (Days 2-5) prior to Carbamazepine initiation were reported under this arm.	0 / 30	0 / 30	4 / 30
Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)Participants observed for adverse events during Carbamazepine alone (Days 6-18 except Day 15) and follow-up period (Days 19-35) were reported under this arm.	0 / 29	0 / 29	12 / 29
Orforglipron + Carbamazepine Combination (Day 15)Participants observed for adverse events during Orforglipron + Carbamazepine combination on Day 15 were reported under this arm.	0 / 28	0 / 28	2 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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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