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

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Quinidine

Drug: Orforglipron

Drug: Midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT06704763

27312

J2A-MC-GZPP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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