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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPP | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam + Orforglipron + Quinidine | Experimental | Participants received:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron | PK: AUC0-inf of Orforglipron. | 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. | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8 |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam | PK: AUC0-inf of Midazolam. | 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Contact Lilly at 1-800-LillyRx (1-800-545-5979) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Salt Lake City | Utah | 84124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam + Orforglipron + Quinidine | Participants received:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam + Orforglipron + Quinidine | Participants received:
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| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron | PK: AUC0-inf of Orforglipron. | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8 |
|
Day -1 through the end of study (Up To 21 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.2 mg Midazolam (Day -1) | Participants observed for adverse events during and after Midazolam on Day -1 and prior to Day 1 dosing were grouped under this arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2024 | Apr 16, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2024 | Apr 16, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
| D008874 | Midazolam |
| D011802 | Quinidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Administered orally |
|
| Quinidine | Drug | Administered orally |
|
PK: Cmax of Midazolam. |
| 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). | 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). | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7 |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Orforglipron | PK: Cmax of Orforglipron. | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8 |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam | PK: AUC0-inf of Midazolam. | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7 |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of Midazolam | PK: Cmax of Midazolam. | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7 |
|
|
|
| Secondary | 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). | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7 |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of 1-Hydroxymidazolam | PK: Cmax of 1-Hydroxymidazolam (metabolite of Midazolam). | All enrolled participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7 |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 4 |
| 27 |
| EG001 | 1 mg Orforglipron (Days 1 to 4) | Participants observed for adverse events during and after Orforglipron on Day 1 and prior to Day 5 dosing were grouped under this arm. | 0 | 27 | 0 | 27 | 7 | 27 |
| EG002 | 200 mg Quinidine BID (Days 5 to 6) | Participants observed for adverse events during and after Quinidine on Days 5, 6 and prior to Day 7 dosing were grouped under this arm. | 0 | 27 | 0 | 27 | 6 | 27 |
| EG003 | 200 mg Quinidine BID + 0.2mg Midazolam (Day 7) | Participants observed for adverse events during and after Quinidine and Midazolam on Day 7, and prior to Day 8 dosing were grouped under this arm. | 0 | 27 | 0 | 27 | 1 | 27 |
| EG004 | 200mg Quinidine BID + 1mg Orforglipron (Day 8 to End of Study) | Participants observed for adverse events during and after Quinidine and Orforglipron on Day 8 were grouped under this arm. | 0 | 27 | 0 | 27 | 7 | 27 |
| Dry eye | Eye disorders | MedDRA 27.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Rectal tenesmus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Muscle contractions involuntary | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
|