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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT06704763 (opens ClinicalTrials.gov in a new tab)Other id27312Other idJ2A-MC-GZPP
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
27 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
6 Dec 2024
Primary completion
5 Feb 2025
Completion
5 Feb 2025
First posted
26 Nov 2024
Last update posted
26 May 2026
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 1

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

    NCT06704763

    6 Dec 2024 to 5 Feb 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug
  • MidazolamDrug
  • QuinidineDrug

Arms1

  • Experimental

    Midazolam + Orforglipron + Quinidine

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8

    Registry description

    PK: AUC0-inf of Orforglipron.

  2. PK: Maximum Observed Concentration (Cmax) of Orforglipron

    Time frame · Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8

    Registry description

    PK: Cmax of Orforglipron.

Secondary outcomes(4)

  1. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Midazolam

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

    Registry description

    PK: AUC0-inf of Midazolam.

  2. PK: Maximum Concentration (Cmax) of Midazolam

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

    Registry description

    PK: Cmax of Midazolam.

  3. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of 1-Hydroxymidazolam

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

    Registry description

    PK: AUC0-inf of 1-Hydroxymidazolam (metabolite of Midazolam).

  4. PK: Maximum Concentration (Cmax) of 1-Hydroxymidazolam

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

    Registry description

    PK: Cmax of 1-Hydroxymidazolam (metabolite of Midazolam).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron

GroupValue (nanogram*hour per milliliter)Spread
Midazolam + Orforglipron + Quinidine89.930.4
Primary outcomeGeometric mean· 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

GroupValue (nanogram per milliliter)Spread
Midazolam + Orforglipron + Quinidine4.1132.2
Secondary and other outcome results(4)
Secondary outcomeGeometric mean· 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 Midazolam

GroupValue (nanogram*hour per milliliter)Spread
Midazolam + Orforglipron + Quinidine2.0641.7
Secondary outcomeGeometric mean· 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

GroupValue (nanogram per milliliter)Spread
Midazolam + Orforglipron + Quinidine0.72535.2
Secondary outcomeGeometric mean· 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

GroupValue (nanogram*hour per milliliter)Spread
Midazolam + Orforglipron + Quinidine0.67639.2
Secondary outcomeGeometric mean· 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

GroupValue (nanogram per milliliter)Spread
Midazolam + Orforglipron + Quinidine0.22439.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
0.2 mg Midazolam (Day -1)Participants observed for adverse events during and after Midazolam on Day -1 and prior to Day 1 dosing were grouped under this arm.0 / 270 / 274 / 27
1 mg Orforglipron (Days 1 to 4)Participants observed for adverse events during and after Orforglipron on Day 1 and prior to Day 5 dosing were grouped under this arm.0 / 270 / 277 / 27
200 mg Quinidine BID (Days 5 to 6)Participants observed for adverse events during and after Quinidine on Days 5, 6 and prior to Day 7 dosing were grouped under this arm.0 / 270 / 276 / 27
200 mg Quinidine BID + 0.2mg Midazolam (Day 7)Participants observed for adverse events during and after Quinidine and Midazolam on Day 7, and prior to Day 8 dosing were grouped under this arm.0 / 270 / 271 / 27
200mg Quinidine BID + 1mg Orforglipron (Day 8 to End of Study)Participants observed for adverse events during and after Quinidine and Orforglipron on Day 8 were grouped under this arm.0 / 270 / 277 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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