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Completed

NCT Number: NCT06704763

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

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.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

midazolam

Drug

Administered orally

Quinidine

Drug

Administered orally

Primary outcomes

  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

    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

    PK: Cmax of Orforglipron.

Secondary outcomes

  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

    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

    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

    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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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