Orforglipron Interaction Study in Healthy Subjects

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Cardiovascular, Respiratory, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

27 Participants Needed

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Orforglipron orally, either alone or with quinidine, to assess pharmacokinetics

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Orforglipron

Trial Overview The 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

Group I: Orforglipron Experimental Treatment 3 Interventions

Orforglipron administered orally either alone or with another investigational agent

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