Orforglipron for Hypertension

Recruiting at 90 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

Disqualifiers: Heart failure, Stroke, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

974 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 safety and effectiveness in reducing high blood pressure in individuals who are overweight or have obesity. Participants will receive either the drug or a placebo (a pill with no active ingredient) to compare results. Eligible participants have high blood pressure, are not currently on treatment, or have been on stable medication for at least 30 days, and have a BMI (body mass index) of 25 or more. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on stable antihypertensive medications for at least 30 days before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that orforglipron has been tested in earlier studies for safety. Participants in these studies experienced a decrease in A1C levels, which measures blood sugar control, without any major safety issues reported. The treatment successfully completed advanced trials, indicating it is generally well-tolerated.

Another study on orforglipron found significant weight loss, which can benefit people dealing with obesity or being overweight. Although this study didn't focus on side effects, no major concerns were noted.

Orforglipron is a type of medication called a GLP-1 receptor agonist, which helps control blood sugar. These medications usually have known safety profiles. Since orforglipron has completed advanced trials for other conditions, it suggests the medication is reasonably safe. However, as with any treatment, individual reactions can vary, so it's important to consider personal health and consult with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Orforglipron is unique because it introduces a new approach to managing hypertension by targeting the glucagon-like peptide-1 (GLP-1) receptor. Unlike standard treatments like ACE inhibitors, beta-blockers, or calcium channel blockers, which focus on different pathways to control blood pressure, Orforglipron taps into the GLP-1 pathway, potentially offering a fresh mechanism to lower blood pressure. Additionally, its oral administration makes it more convenient compared to injectable options in the GLP-1 receptor agonist group. Researchers are excited about Orforglipron because it could provide an effective alternative for patients who might not respond well to current medications, expanding the toolkit for managing hypertension.

What evidence suggests that this trial's treatments could be effective for hypertension?

Studies have shown that orforglipron can significantly improve blood pressure, making it a promising option for treating hypertension. Research indicates that orforglipron, a GLP-1 receptor agonist, effectively lowers systolic blood pressure in patients. Improvements in other health markers, such as waist size and cholesterol levels, have also been observed. This is important because better overall health often leads to improved blood pressure control. Furthermore, orforglipron reduces blood sugar levels, which is beneficial since many individuals with high blood pressure also face blood sugar issues. Overall, early evidence supports its potential effectiveness in managing high blood pressure. Participants in this trial will receive orforglipron in one of the study arms, while others may receive 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. Participants should meet specific health criteria to be included, but the exact inclusion and exclusion details aren't provided here.

Inclusion Criteria

When measured at the clinic, is your usual blood pressure between 140/90 and 180/110?

Exclusion Criteria

Do you have severe kidney problems or are you on dialysis?

Is your A1c above 8% or has your diabetes caused kidney damage?

Has a doctor told you that you have advanced heart failure or a very weak heart pump?

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 safety and efficacy 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 Screening trial is testing a new medication called Orforglipron against a placebo (a substance with no active drug) to see if it can safely and effectively treat high blood pressure in people who are obese or overweight.

How Is the Trial Designed?

Group I: Orforglipron (GZL2) Experimental Treatment 2 Interventions

Participants will receive orforglipron orally or placebo.

Group II: Orforglipron (GZL1) Experimental Treatment 2 Interventions

Participants will receive orforglipron orally or 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

Published Research Related to This Trial

Hypertensive patients with chronic renal failure have a worse prognosis compared to normotensive patients, highlighting the importance of effective antihypertensive treatment.

Antihypertensive therapies, particularly ACE inhibitors and calcium antagonists, have been shown to improve the progression of chronic renal failure by targeting key factors involved in hypertension and organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of antihypertensive therapy on the course of renal failure. Lederle, RM.[2005]

Most hypertensive patients require combination drug therapy for effective blood pressure control, with fixed combination drugs being preferred to improve patient compliance and minimize side effects.

Current blood pressure targets are set at 135/80 mm Hg for essential hypertension and 120/70 mm Hg for patients with diabetes or renal diseases, with ACE inhibitors or angiotensin II blockers recommended for those with renal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Goal blood pressure values from the nephrologic viewpoint]. Hörl, WH.[2007]

Citations

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

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ... Waist circumference, systolic blood pressure, triglyceride levels, and non-HDL cholesterol levels significantly improved with orforglipron ...

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, shows efficacy & safety 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. 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.

4. 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, ...

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/eli-lilly-orforglipron-superior-efficacy-multiple-trials-type-2-diabetes

Eli Lilly's Orforglipron Shows Superior Efficacy Across ... Detailed results from the study showed: Orforglipron achieved greater A1C reduction than oral semaglutide at 52 weeks: –1.9% (12mg) and –2.2% ( ...

6. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2025/09/24/16/48/ATTAIN-1

ATTAIN-1: Oral Orforglipron Significantly Reduces Weight ... Results showed that at 72 weeks, the mean change in body weight for patients taking orforglipron was −7.5% with 6 mg, −8.4% with 12 mg and −11.2 ...