CompletedNCT06370728Updated Jul 17, 2026Results posted

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

A Phase 1 interventional study of Orforglipron and Carbamazepine in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Not applicable
Ages: 21 Years to 70 Years
Sex: All

Study summary

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.

Conditions studied

Healthy

Keywords

Glucagon-Like Peptide (GLP)- 1

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 70 Years
Sexes eligible: All
Accepts 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

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 design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

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
Drug: Orforglipron · Drug: Carbamazepine

Interventions

DrugOrforglipron
Administered orally
Also known as: LY3502970
DrugCarbamazepine
Administered orally

What researchers measure

Primary outcomes

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

Results

Posted Jul 17, 2026

Participant flow

Participant flow — Overall Study
Milestone	Orforglipron + Carbamazepine
Started	30
Safety population day 1	30
Completed	24
Not completed	6
Withdrew: Adverse event	6

Outcome measures

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

PK: 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)
Reported as:: Geometric mean · nanograms*hours per milliliter(ng*h/mL)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron
nanogramshours per milliliter(ngh/mL)	Orforglipron + Carbamazepine
Day 1 (Orforglipron alone)	104 ± 26.6
Day 15 (Orforglipron + Carbamazepine)	18.5 ± 41.7

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

PK: 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)
Reported as:: Geometric mean · nanograms*hours per milliliter(ng*h/mL)

PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
nanogramshours per milliliter(ngh/mL)	Orforglipron + Carbamazepine
Day 1 (Orforglipron alone)	93.4 ± 24.6
Day 15 (Orforglipron + Carbamazepine)	15.8 ± 51.8

PrimaryPK: Maximum Observed Concentration (Cmax) of Orforglipron

PK: 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)
Reported as:: Geometric mean · nanograms per milliliter (ng/mL)

PK: Maximum Observed Concentration (Cmax) of Orforglipron
nanograms per milliliter (ng/mL)	Orforglipron + Carbamazepine
Day 1 (Orforglipron alone)	4.97 ± 31.0
Day 15 (Orforglipron + Carbamazepine)	2.22 ± 47.3

Adverse events

Collected over Baseline to end of follow-up (up to 35 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Orforglipron Alone (Days 1-5)	0/30 (0%)	0/30 (0%)	4/30 (13.3%)
Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)	0/29 (0%)	0/29 (0%)	12/29 (41.4%)
Orforglipron + Carbamazepine Combination (Day 15)	0/28 (0%)	0/28 (0%)	2/28 (7.1%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Orforglipron Alone (Days 1-5)	Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)	Orforglipron + Carbamazepine Combination (Day 15)
SomnolenceNervous system disorders	0/30	5/29	0/28
HeadacheNervous system disorders	0/30	3/29	0/28
Decreased appetiteMetabolism and nutrition disorders	3/30	2/29	1/28
NauseaGastrointestinal disorders	1/30	0/29	2/28
ThrombocytopeniaBlood and lymphatic system disorders	0/30	2/29	0/28
ConstipationGastrointestinal disorders	0/30	2/29	0/28
Abdominal painGastrointestinal disorders	0/30	0/29	1/28
VertigoEar and labyrinth disorders	0/30	1/29	0/28
VomitingGastrointestinal disorders	0/30	1/29	0/28
FatigueGeneral disorders	0/30	1/29	0/28

Baseline characteristics

All enrolled participants.

Age, Continuous
Age, Continuous(years)	Orforglipron + Carbamazepine
Mean	46.0 ± 12.3

Sex: Female, Male
Sex: Female, Male(Participants)	Orforglipron + Carbamazepine
Female	6
Male	24

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Orforglipron + Carbamazepine
Hispanic or Latino	9
Not Hispanic or Latino	21
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Orforglipron + Carbamazepine
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	12
White	17
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(Participants)	Orforglipron + Carbamazepine
United States	30

Study locations

1 site

ICON Early Phase Services
San Antonio, Texas 78209, United States

References and documents

Study documents

Study protocol · Jan 31, 2024
Statistical analysis plan · Apr 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06370728
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Apr 17, 2024
Start date: May 6, 2024
Primary completion: Jul 23, 2024
Completion: Jul 23, 2024
Results posted: Jul 17, 2026
Last update: Jul 17, 2026

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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