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CompletedPhase 1Results posted

A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants

A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

27

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18.5-35Healthy volunteers

Primary endpoints

AUCPK: Maximum Observed Concentration (Cmax) of OrforglipronAUC of Orforglipron

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06704763
Org study ID27312
Secondary IDJ2A-MC-GZPPEli Lilly and Company

Timeline

Milestones

Study first posted2024-11-26actual
Study start2024-12-06actual
Primary completion2025-02-05actual
Study completion2025-02-05actual
Last update posted2026-05-26actual
Results first posted2026-05-26actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age21 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

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

Exclusion criteria

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
Have known allergies to:
quinidine
midazolam
orforglipron
related compounds, or
any components of the formulation

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

10 endpoints
Primary/registry result

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

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter95% CI
Midazolam + Orforglipron + QuinidineDay 189.9
Day 879.1
Primary/registry result

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

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram per milliliter95% CI
Midazolam + Orforglipron + QuinidineDay 14.11
Day 83.06
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron

Time frame:Baseline to Study Completion (Up to 2 Weeks)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Concentration (Cmax) of Orforglipron

Time frame:Baseline to Study Completion (Up to 2 Weeks)

Cmax

concentration, descriptive

Secondary/registry result

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

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter95% CI
Midazolam + Orforglipron + QuinidineDay -12.06
Day 72.73
Secondary/registry result

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

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram per milliliter95% CI
Midazolam + Orforglipron + QuinidineDay -10.725
Day 70.999
Secondary/registry result

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

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter95% CI
Midazolam + Orforglipron + QuinidineDay -10.676
Day 70.999
Secondary/registry result

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

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram per milliliter95% CI
Midazolam + Orforglipron + QuinidineDay -10.224
Day 70.343
Secondary/protocol endpoint

PK: AUC of Midazolam

Time frame:Baseline to Study Completion (Up to 2 Weeks)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Cmax of Midazolam

Time frame:Baseline to Study Completion (Up to 2 Weeks)

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.