Orforglipron for Hypertension

Recruiting at 72 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

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

Trial Summary

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.

What data supports the effectiveness of the drug Orforglipron for treating hypertension?

The research highlights that treating high blood pressure (hypertension) is beneficial, especially in older adults, and that a combination of drugs is often needed to achieve optimal blood pressure control. While Orforglipron is not specifically mentioned, the general effectiveness of antihypertensive drugs in improving health outcomes is supported. ^{1 2 3 4 5}

How does the drug Orforglipron differ from other treatments for hypertension?

Orforglipron is unique because it is a glucagon-like peptide-1 receptor agonist, similar to liraglutide, which has been shown to reduce blood pressure in patients with type 2 diabetes. This class of drugs works by mimicking a hormone that helps regulate blood sugar and may also lower blood pressure, offering a novel approach compared to traditional hypertension treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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

Is your high blood pressure due to kidney, hormone, or artery problems?

Have you had a heart attack, stroke, or been in the hospital for heart problems in the past year?

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

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Renal consequences of arterial hypertension. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Hypertension In The Elderly. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Single-pill telmisartan and amlodipine: a rational combination for the treatment of hypertension. [2021]

5. Austria pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Hypertension in diabetic nephropathy: epidemiology, mechanisms, and management. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Lactotripeptides (Isoleucine-Proline-Proline/Valine-Proline-Proline) on Blood Pressure and Arterial Stiffness Changes in Subjects with Suboptimal Blood Pressure Control and Metabolic Syndrome: A Double-Blind, Randomized, Crossover Clinical Trial. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Time course and mechanisms of the anti-hypertensive and renal effects of liraglutide treatment. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of the glucagon-like peptide-1 receptor agonist liraglutide on 24-h ambulatory blood pressure in patients with type 2 diabetes and stable coronary artery disease: a randomized, double-blind, placebo-controlled, crossover study. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

The impact of lactotripeptides on blood pressure response in stage 1 and stage 2 hypertensives. [2022]