Orforglipron Interaction Study in Healthy Subjects
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Eli Lilly and Company
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
CL
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for healthy individuals who can participate in a study lasting up to 8 weeks, including screening. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting medications or conditions.Inclusion Criteria
My hemoglobin level meets the required threshold based on my birth sex.
My weight is at least 45 kg and my BMI is between 18.5 and 35.
I am generally healthy as confirmed by recent medical exams and tests.
Exclusion Criteria
I have a stomach or intestine condition that could worsen with certain diabetes medications.
Have known allergies to quinidine, midazolam, orforglipron, related compounds, or any components of the formulation
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
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Treatment Details
Interventions
- Orforglipron (Other)
Trial OverviewThe study is testing how the drug quinidine affects the blood levels and elimination of another drug called orforglipron when taken orally by healthy people. It aims to understand their interaction within the body.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: OrforglipronExperimental Treatment3 Interventions
Orforglipron administered orally either alone or with another investigational agent
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Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University