Orforglipron Interaction Study in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the drug orforglipron (a GLP-1 receptor agonist) interacts with quinidine in the body. It seeks to understand how these drugs affect each other's levels in the bloodstream and their breakdown and removal rates. The trial targets individuals who are generally healthy and have no major health issues that could impact drug processing. Participants should not have allergies to orforglipron, quinidine, or similar drugs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants and involves drug interactions, it's possible that you may need to pause some medications. Please consult with the study team for specific guidance.
Is there any evidence suggesting that orforglipron is likely to be safe for humans?
Earlier studies have shown that orforglipron, an oral pill, is mostly safe for people. The most common side effects involved the stomach and digestion, typically occurring early in treatment. Serious side effects were rare and appeared at rates similar to those in people taking a placebo. This indicates that orforglipron is generally well-tolerated. No unexpected safety issues have emerged. This information suggests that orforglipron could be safe to use, but ongoing research will help confirm this.12345
Why do researchers think this study treatment might be promising?
Orforglipron is unique because it is an oral treatment option, which is different from many current treatments for conditions like type 2 diabetes that often require injections. This oral administration makes it easier and potentially more appealing for patients to use. Researchers are excited about Orforglipron because it targets the GLP-1 receptor, similar to some existing treatments, but with the convenience of a pill. This could improve patient adherence and overall effectiveness in managing the condition.
What evidence suggests that orforglipron might be an effective treatment?
Studies have shown that orforglipron effectively lowers blood sugar levels. This medication activates a specific receptor in the body to help reduce blood sugar. Earlier research demonstrated that orforglipron lowered A1C levels, which measure average blood sugar, by 1.3% to 1.6%. This suggests it can effectively manage blood sugar. Additionally, orforglipron is taken as a pill, offering a convenient alternative to treatments requiring injections.24678
Who Is on the Research Team?
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Orforglipron orally, either alone or with quinidine, to assess pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Orforglipron
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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