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

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Orforglipron; Drug: Midazolam; Drug: Quinidine

• Registration Number: NCT06704763
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Study Start: 2024-12
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

• 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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orforglipron	Orforglipron	Orforglipron administered orally either alone or with another investigational agent
Orforglipron	Midazolam	Orforglipron administered orally either alone or with another investigational agent
Orforglipron	Quinidine	Orforglipron administered orally either alone or with another investigational agent

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron	Baseline to Study Completion (Up to 2 Weeks)	PK: AUC of Orforglipron
PK: Maximum Concentration (Cmax) of Orforglipron	Baseline to Study Completion (Up to 2 Weeks)	PK: Cmax of Orforglipron

Secondary Outcome Measures

Name	Time	Method
PK: Cmax of Midazolam	Baseline to Study Completion (Up to 2 Weeks)	PK: Cmax of Midazolam
PK: AUC of Midazolam	Baseline to Study Completion (Up to 2 Weeks)	PK: AUC of Midazolam

Trial Locations

Locations (1)

ICON; 🇺🇸 Salt Lake City, Utah, United States