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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06704763

Run by

Eli Lilly and Company

People needed

27

Starts

2024-12-06

Expected to finish

2025-02-05

Last updated by the study team

2026-05-26

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ICON — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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