Orforglipron for High Blood Pressure

Recruiting in Columbus (<10 mi)

+102 other locations

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

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?

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

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.

How does the drug Orforglipron differ from other treatments for high blood pressure?

Orforglipron is unique because it is a glucagon-like peptide-1 receptor agonist (GLP-1 RA), similar to liraglutide, which has shown potential in lowering blood pressure while also providing cardioprotective effects. This dual action makes it different from many traditional blood pressure medications that primarily focus on reducing blood pressure alone. ^{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 9 AM - 5 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. England pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Blood pressure-lowering effects of GLP-1 receptor agonists exenatide and liraglutide: a meta-analysis of clinical trials. [2022]

5. 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]