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

NCT06704763 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27312J2A-MC-GZPP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  PK: AUC of Orforglipron

  Baseline to Study Completion (Up to 2 Weeks)

• PK: Maximum Concentration (Cmax) of Orforglipron

  PK: Cmax of Orforglipron

  Baseline to Study Completion (Up to 2 Weeks)

Secondary Outcomes (2)

• PK: AUC of Midazolam

  Baseline to Study Completion (Up to 2 Weeks)

• PK: Cmax of Midazolam

  Baseline to Study Completion (Up to 2 Weeks)

Study Arms (1)

Orforglipron

EXPERIMENTAL

Orforglipron administered orally either alone or with another investigational agent

Drug: Orforglipron; Drug: Midazolam; Drug: Quinidine

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Orforglipron

Midazolam DRUG

Administered orally

Orforglipron

Quinidine DRUG

Administered orally

Orforglipron

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ICON

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

orforglipron; Midazolam; Quinidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines

Study Officials

• Contact Lilly at 1-800-LillyRx (1-800-545-5979)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 6, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)