Orforglipron for High Blood Pressure

Recruiting at 119 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

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: 12 weeks

487 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of orforglipron, a medication for individuals with high blood pressure who are also overweight or have obesity. The focus is on determining if this medication can safely manage high blood pressure compared to a placebo, which contains no active drug. Individuals who have struggled with high blood pressure and carry extra weight might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please refer to the GZPL master protocol or consult with the trial coordinators for more details.

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

Studies have shown that orforglipron, a pill, is generally safe and easy to tolerate. Research suggests it is as safe as other similar drugs administered by injection. Earlier studies linked orforglipron to improvements in heart health markers, such as cholesterol levels, without causing serious side effects. While minor side effects might occur, the medication has not demonstrated any major safety issues in the studies conducted so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for high blood pressure, which often include ACE inhibitors or beta-blockers, Orforglipron offers a fresh approach by being taken orally and potentially having a new mechanism of action. Researchers are particularly excited about Orforglipron because it might provide a more convenient option for patients while effectively managing blood pressure levels. This could lead to better adherence to treatment plans and improved outcomes for those struggling with this condition.

What evidence suggests that orforglipron might be an effective treatment for high blood pressure?

Research has shown that orforglipron, a GLP-1 receptor agonist, yields promising results in lowering blood pressure. In earlier studies, participants taking orforglipron experienced significant reductions in blood pressure and improvements in other health indicators, such as cholesterol levels and inflammation. This trial will assess orforglipron's effectiveness in treating high blood pressure, with participants receiving either orforglipron or a placebo. The medication is also known for improving diastolic blood pressure, the lower number in a blood pressure reading. Additionally, orforglipron has effectively lowered A1C levels, which measure blood sugar control and can benefit heart health. These findings suggest orforglipron might be effective for treating high blood pressure, particularly in individuals who are overweight or obese. ^{1 2 3 4 6}

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 individuals with high blood pressure who are also overweight or obese. Specific criteria for joining aren't provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Refer to the GZPL master protocol for screening eligibility.

Exclusion Criteria

Refer to the GZPL master protocol for screening eligibility.

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 to evaluate efficacy and safety for hypertension in participants with obesity or overweight

12 weeks

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 effectiveness and safety of a new medication called Orforglipron compared to a placebo in treating high blood pressure among those who are overweight or obese.

How Is the Trial Designed?

Group I: Orforglipron Experimental Treatment 1 Intervention

Participants will receive orforglipron orally.

Group II: Placebo Placebo Group 1 Intervention

Administered placebo.

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

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ... Orforglipron was associated with improvements in diastolic blood pressure, other lipid fractions, high-sensitivity C-reactive protein, and ...

2. investor.lilly.com investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically

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.

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

Treatment with orforglipron, an oral glucagon like peptide-1 ... In the Phase 2 studies of orforglipron, we observed significant reductions in blood pressure, lipid levels, and inflammatory markers ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06952530

NCT06952530 | A Master Protocol Study of Orforglipron ... GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight. Official Title. A ...

5. withpower.com withpower.com/trial/orforglipron-for-high-blood-pressure-23d68

Orforglipron for High Blood Pressure Trial Overview The ATTAIN-Hypertension study is testing Orforglipron's effectiveness and safety in treating high blood pressure among those who are obese or ...

6. clinicaladvisor.com clinicaladvisor.com/news/orforglipron-reduces-body-weight-in-adults-with-obesity/

Orforglipron Reduces Body Weight in Adults With Obesity Notably, orforglipron was associated with reductions in markers of cardiovascular risk (eg, non-high density lipoprotein [HDL] cholesterol, ...