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 tests a new treatment called orforglipron to determine its effectiveness in lowering high blood pressure in individuals who are overweight or have obesity. The study aims to assess the treatment's effectiveness and safety compared to a placebo (a pill with no active medicine). Participants will receive either orforglipron or a placebo. Individuals with high blood pressure and excess weight may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an 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 study coordinators for more details.

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

Research has shown that orforglipron is generally well-tolerated. This oral medication has a safety profile similar to injectable treatments in the same category. It has been tested in individuals who are overweight or have obesity, demonstrating positive effects on heart health, such as lowering certain cholesterol levels.

While side effects can occur, they are usually mild and similar to those of other treatments in its category. These studies provide extensive information about its safety, especially since orforglipron is already in a later phase of clinical trials. Researchers have collected solid safety data from earlier studies. Prospective trial participants might find this background reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Orforglipron is unique because it offers a novel approach to treating high blood pressure by targeting the GLP-1 receptor, a mechanism not typically used by standard treatments like ACE inhibitors or beta-blockers. This oral medication could provide an alternative for patients who might not respond well to or tolerate current therapies. Researchers are particularly excited about the potential for Orforglipron to offer effective blood pressure control with fewer side effects, making it a promising option in the fight against hypertension.

What evidence suggests that orforglipron might be an effective treatment for hypertension?

Research has shown that orforglipron, an oral medication, can help lower blood pressure. Studies have found that it not only reduces blood pressure but also improves cholesterol levels and reduces inflammation. In one study, patients taking orforglipron experienced significant drops in their blood pressure and other related health markers. The treatment also effectively lowered A1C levels, which measure blood sugar, by 1.3% to 1.6%. This trial will evaluate orforglipron's effectiveness in treating high blood pressure, especially in people who are overweight or obese. Participants in this trial will receive either orforglipron or a placebo. ^{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 dealing with obesity or being overweight. Specific eligibility will be determined based on the broader GZPL master protocol, which outlines detailed inclusion and exclusion criteria.

Inclusion Criteria

Refer to the GZPL master protocol study for screening eligibility.

Exclusion Criteria

Refer to the GZPL master protocol study 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 ATTAIN-Hypertension study is testing Orforglipron's effectiveness and safety in treating high blood pressure among those who are obese or overweight. Participants will either receive Orforglipron or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Orforglipron Experimental Treatment 1 Intervention

Participants will receive orforglipron orally.

Group II: Placebo Placebo Group 1 Intervention

Participants receive 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, ...