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

NCT06704763 | Completed Phase 1 Results 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 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

Secondary Outcomes (4)

• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (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

  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

  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

  Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post midazolam dose on days -1, 7

Study Arms (1)

Midazolam + Orforglipron + Quinidine

EXPERIMENTAL

Participants received: * Day -1: single dose of 0.2 milligram (mg) midazolam. * Day 1: single dose of 1 mg orforglipron. * Days 5 to 6: 200 mg quinidine twice daily (BID). * Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam. * Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron.

Drug: Orforglipron; Drug: Midazolam; Drug: Quinidine

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Midazolam + Orforglipron + Quinidine

Midazolam DRUG

Administered orally

Midazolam + Orforglipron + Quinidine

Quinidine DRUG

Administered orally

Midazolam + Orforglipron + Quinidine

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

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

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)