HealthyPhase 1NCT06370728

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

A Phase 1 study testing Orforglipron and Carbamazepine in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Orforglipron and Carbamazepine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 6 May 2024to 23 Jul 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

ICON Early Phase Services
San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants

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: Healthy
Being tested: Orforglipron, Carbamazepine
Keywords: Glucagon-Like Peptide (GLP)- 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OrforglipronDrug
Also called LY3502970
Administered orally
CarbamazepineDrug
Administered orally

Study groups in NCT06370728
Study group	Role	What they receive
Orforglipron + Carbamazepine	Experimental	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 Receives: Drug: Orforglipron; Drug: Carbamazepine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 202423 Jul 2024

First posted17 Apr 2024
Study start6 May 2024
Primary completion23 Jul 2024
Study completion23 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT06370728
Sponsor's protocol ID: 18621
Other IDs: J2A-MC-GZPJ
Status last verified: Jun 2026
First submitted: 15 Apr 2024
Last updated: 17 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants
ClinicalTrials.gov ID: NCT06370728
Acronym / sponsor ID: 18621
Conditions: Healthy
Keywords: Glucagon-Like Peptide (GLP)- 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 6 May 2024 (actual)
Primary completion: 23 Jul 2024 (actual)
Study completion: 23 Jul 2024 (actual)
First posted: 17 Apr 2024 (actual)
Results: Posted 17 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Orforglipron + Carbamazepine	Experimental	Drug: Orforglipron, Drug: CarbamazepineParticipants 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

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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
Have venous access sufficient to allow for blood sampling.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OrforglipronAlso: LY3502970Administered orally	Drug	Orforglipron + Carbamazepine
CarbamazepineAdministered orally	Drug	Orforglipron + Carbamazepine

Primary outcome

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

Results and safety

Results posted to the registry on 17 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Orforglipron + Carbamazepine	30	24

Primary outcome: 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). Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter(ng*h/mL)

Measure	Orforglipron + Carbamazepine n = 30
Day 1 (Orforglipron alone)	104 (26.6)
Day 15 (Orforglipron + Carbamazepine)	18.5 (41.7)

Population analysed: All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.

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

Measure	Orforglipron + Carbamazepine n = 30
Day 1 (Orforglipron alone)	93.4 (24.6)
Day 15 (Orforglipron + Carbamazepine)	15.8 (51.8)

Population analysed: All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.

Primary outcome: PK: Maximum Observed Concentration (Cmax) of Orforglipron

Measure	Orforglipron + Carbamazepine n = 30
Day 1 (Orforglipron alone)	4.97 (31.0)
Day 15 (Orforglipron + Carbamazepine)	2.22 (47.3)

Population analysed: All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.

Adverse events

Time frame: Baseline to end of follow-up (up to 35 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Orforglipron Alone (Days 1-5)	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30
Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)	0 of 29 (0%)	12 of 29 (41.4%)	0 of 29
Orforglipron + Carbamazepine Combination (Day 15)	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Orforglipron and Carbamazepine in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06370728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.