HealthyPhase 1NCT06704763
A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants
A Phase 1 study testing Orforglipron, Midazolam and Quinidine in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants. The study will last up to approximately 8 weeks including screening. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Orforglipron, Midazolam and Quinidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 5 Feb 2025
- 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
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG)
- Have a hemoglobin level of:
- at least 11.4 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB), and
- at least 12.5 g/dL for individuals assigned male at birth (AMAB)
- Have a body weight equal to or greater than 45 kilograms (kg), and a body mass index within the range of 18.5 to 35.0 kilogram per square meter (kg/m²) at screening
Who cannot join
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting risk when taking orforglipron, midazolam, or quinidine; or interfering with the interpretation of data
- Have a 12 lead electrocardiogram (ECG) abnormality, including known prolongation of QT/QTc interval, significant bradycardia, significant heart blocks or a history of any risk factors for ventricular arrhythmia, heart failure, hypokalemia or hypomagnesemia, or other factors that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure or pulse rate, deemed to be clinically significant by the investigator
- Have a history of benign ethnic neutropenia
- Have a GI disease or disorder, such as relevant esophageal reflux or gall bladder disease, which could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or impacts gastric emptying, for example gastric bypass surgery or pyloric stenosis, except for appendectomy
- Have a history or presence of pancreatitis, including chronic pancreatitis or idiopathic acute pancreatitis
Show all 12Show fewer
- Have known allergies to:
- quinidine
- midazolam
- orforglipron
- related compounds, or
- any components of the formulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants
The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants.
The study will last up to approximately 8 weeks including screening.
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
MidazolamDrug
Administered orally
QuinidineDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Midazolam + Orforglipron + Quinidine | Experimental | Participants received:
* Day -1: single dose of 0.2 milligram (mg) midazolam.
* Day 1: single dose of 1 mg orforglipron.
* Days 5 to 6: 200 mg quinidine twice daily (BID).
* Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam.
* Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron. Receives: Drug: Orforglipron; Drug: Midazolam; Drug: Quinidine |
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 (AUC0-inf) of Orforglipron
PK: AUC0-inf of Orforglipron.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8
PK: Maximum Observed Concentration (Cmax) of Orforglipron
PK: Cmax of Orforglipron.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8
Secondary outcomes (4)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam
PK: AUC0-inf of Midazolam.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
PK: Maximum Concentration (Cmax) of Midazolam
PK: Cmax of Midazolam.
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of 1-Hydroxymidazolam
PK: AUC0-inf of 1-Hydroxymidazolam (metabolite of Midazolam).
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
PK: Maximum Concentration (Cmax) of 1-Hydroxymidazolam
PK: Cmax of 1-Hydroxymidazolam (metabolite of Midazolam).
Measured: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start6 Dec 2024
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact Lilly at 1-800-LillyRx (1-800-545-5979), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704763
- Sponsor's protocol ID
- 27312
- Other IDs
- J2A-MC-GZPP
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2024
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants
- ClinicalTrials.gov ID
- NCT06704763
- Acronym / sponsor ID
- 27312
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants.
The study will last up to approximately 8 weeks including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam + Orforglipron + Quinidine | Experimental | Drug: Orforglipron, Drug: Midazolam, Drug: QuinidineParticipants received: * Day -1: single dose of 0.2 milligram (mg) midazolam. * Day 1: single dose of 1 mg orforglipron. * Days 5 to 6: 200 mg quinidine twice daily (BID). * Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam. * Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG)
- Have a hemoglobin level of:
- Have a body weight equal to or greater than 45 kilograms (kg), and a body mass index within the range of 18.5 to 35.0 kilogram per square meter (kg/m²) at screening
Key exclusion criteria (12 listed)
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting risk when taking orforglipron, midazolam, or quinidine; or interfering with the interpretation of data
- Have a 12 lead electrocardiogram (ECG) abnormality, including known prolongation of QT/QTc interval, significant bradycardia, significant heart blocks or a history of any risk factors for ventricular arrhythmia, heart failure, hypokalemia or hypomagnesemia, or other factors that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure or pulse rate, deemed to be clinically significant by the investigator
- Have a history of benign ethnic neutropenia
- Have a GI disease or disorder, such as relevant esophageal reflux or gall bladder disease, which could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or impacts gastric emptying, for example gastric bypass surgery or pyloric stenosis, except for appendectomy
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 | Midazolam + Orforglipron + Quinidine |
| MidazolamAdministered orally | Drug | Midazolam + Orforglipron + Quinidine |
| QuinidineAdministered orally | Drug | Midazolam + Orforglipron + Quinidine |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8
PK: AUC0-inf of Orforglipron.
PK: Maximum Observed Concentration (Cmax) of Orforglipron
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8
PK: Cmax of Orforglipron.
4 secondary outcomes
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
PK: Maximum Concentration (Cmax) of Midazolam
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of 1-Hydroxymidazolam
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
PK: Maximum Concentration (Cmax) of 1-Hydroxymidazolam
Time frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
Contact Lilly at 1-800-LillyRx (1-800-545-5979) 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, Midazolam and Quinidine 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 5 inclusion and 12 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 26 May 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 26 May 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 (AUC0-inf) of Orforglipron (time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.