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
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

CL

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

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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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: OrforglipronExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Lilly's oral GLP-1, orforglipron, demonstrated statistically ...Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.
The pharmacological basis for nonpeptide agonism of ...Here, we characterized the pharmacological properties of orforglipron in comparison with peptide-based GLP-1R agonists and other NPAs.
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37344954/
Orforglipron (LY3502970), a novel, oral non-peptide ...Aim: To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of orforglipron (LY3502970), ...
Structural basis for GLP-1 receptor activation by ...These head-to-head experiments with exenatide demonstrate that an orally administered nonpeptide agonist of the GLP-1R can reduce hyperglycemia ...
Orforglipron (LY3502970), a novel, oral non‐peptide glucagon ...Orforglipron may provide a safe and effective once-daily oral treatment alternative to injectable GLP-1RAs or peptide oral formulations without water and food ...
Safety Data SheetHazards not otherwise classified. There are no adverse physical or health effects known that are not covered by the hazard classes of the.
NCT06672939 | A Study of Orforglipron (LY3502970) in ...The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once ...
ORFORGLIPRON– Serious adverse events were rare (<1%) and occurred at rates comparable to placebo, with no new or unexpected safety signals identified pmc.
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