Status:
COMPLETED
A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Obese
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and togeth...
Eligibility Criteria
Inclusion
- Participants who are overtly healthy as determined by medical history and physical examination.
- Have body mass index (BMI) equal to or greater than 27 kilograms per meter squared (kg/m²), inclusive, at screening.
- Have an estimated glomerular filtration rate equal to or greater than 60 milliliters per minute (mL/min).
- Males and females who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
- Have venous access sufficient to allow for blood sampling.
Exclusion
- Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
- Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years.
- Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.
- Have known clinically significant gastric emptying abnormality.
- Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.
- Have an abnormal 12-lead electrocardiogram (ECG) at screening.
- Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug.
- Participants must not be currently participating in or completed a clinical trial within the last 90 days.
- Have a known allergy or hypersensitivity to midazolam, simvastatin, rosuvastatin, or digoxin.
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06186622
Start Date
January 2 2024
End Date
July 10 2024
Last Update
July 22 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Fortrea Clinical Research Unit Inc.
Daytona Beach, Florida, United States, 32117
2
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States, 75247