Clinical trial NCT06704763: A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants
Official title: A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron
timeFrame: Baseline to Study Completion (Up to 2 Weeks)
measure: PK: Maximum Concentration (Cmax) of Orforglipron
timeFrame: Baseline to Study Completion (Up to 2 Weeks)
Secondary outcomes:
measure: PK: AUC of Midazolam
timeFrame: Baseline to Study Completion (Up to 2 Weeks)
measure: PK: Cmax of Midazolam
timeFrame: Baseline to Study Completion (Up to 2 Weeks)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References: