Orforglipron for Heart and Kidney Diseases

Not yet recruiting at 516 trial locations

Overseen By Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Type 1 diabetes, recent heart condition, Class IV heart failure

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how orforglipron affects heart and kidney health. It targets individuals with conditions like atherosclerotic cardiovascular disease (ASCVD), which involves narrowed arteries, and chronic kidney disease (CKD), where the kidneys function suboptimally. Participants will receive either orforglipron or a placebo (a harmless pill with no active medicine) alongside their usual care to compare outcomes. Those diagnosed with ASCVD or CKD may qualify, provided they do not have type 1 diabetes or certain severe heart conditions. The study will last about five years. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that orforglipron is likely to be safe for humans?

Research has shown that orforglipron has undergone testing in several studies to ensure its safety for humans. One study found it to be generally well-tolerated, with side effects similar to other treatments for the same health issues.

Another study confirmed that orforglipron met its goals without causing unexpected problems. It performed as expected and did not lead to any new or serious side effects.

Since this trial is in a later stage, orforglipron has already passed initial safety checks, demonstrating its safety for many people. However, individual experiences may vary. Consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Orforglipron is unique because it targets both heart and kidney diseases through a novel mechanism of action. Unlike standard treatments that might focus on controlling symptoms or managing individual risk factors, Orforglipron works by modulating pathways involved in both cardiovascular and renal functions, potentially offering a more comprehensive approach. Researchers are excited about its oral administration, which could offer a more convenient alternative to injectable treatments, making it easier for patients to adhere to their treatment plans.

What evidence suggests that orforglipron might be an effective treatment for heart and kidney diseases?

Research has shown that orforglipron, a type of medication, may help treat heart and kidney diseases. Studies have found that orforglipron can improve heart health markers, especially in people with type 2 diabetes or those who are overweight. In some trials, participants taking orforglipron lost a significant amount of weight, often linked to better heart health. This medication is taken by mouth, making it easier to use than treatments requiring injections. Overall, these findings suggest that orforglipron could improve heart and kidney health in patients with heart disease and chronic kidney disease. Participants in this trial will receive either orforglipron or a placebo, both alongside standard care, to further evaluate its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). The study will last about 5 years. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions.

Inclusion Criteria

I have heart disease and/or kidney disease.

Exclusion Criteria

Have type 1 diabetes

I have not had a major heart condition in the last 60 days.

I have severe heart failure (NYHA Class IV).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally along with standard of care

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orforglipron

Trial Overview The study is testing the effects of Orforglipron on cardiovascular outcomes compared to a placebo in patients with heart-related diseases or kidney disorders. Participants will be randomly assigned to receive either Orforglipron or a placebo.

How Is the Trial Designed?

Group I: Orforglipron Experimental Treatment 1 Intervention

Participants will receive orforglipron orally + standard of care

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally + standard of care

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07241390

A Study of Orforglipron (LY3502970) on Cardiovascular ... The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511774

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ... In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142847/

Treatment with orforglipron, an oral glucagon like peptide-1 ... Orforglipron treatment was associated with beneficial changes in CV risk markers in participants with T2D and in participants with overweight/obesity without T ...

4. investor.lilly.com investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-successful-third-phase-3-trial

Lilly's oral GLP-1, orforglipron, is successful in third Phase ... For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% ( ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0140673625021658?dgcid=rss_sd_all

Orforglipron, an oral small-molecule GLP-1 receptor ... Here, we present the results of the ATTAIN-2 study, which investigated orforglipron for weight management in adults with a BMI of 27 kg/m2 or ...