120 Participants NeededMy employer runs this trial

Clazakizumab for Cardiovascular Disease

(CLARITY-CRP Trial)

Recruiting at 46 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests clazakizumab, a medication that might reduce inflammation in people at risk for heart problems. Researchers aim to observe how this drug affects a specific blood marker called hsCRP, which indicates inflammation levels. Participants will receive one of three doses of clazakizumab or a placebo (a substance with no active medication) for comparison. Suitable candidates for this trial have long-standing conditions such as heart disease, obesity, type 2 diabetes, high blood pressure, or certain kidney issues, along with higher inflammation levels as shown by a blood test. Participation lasts about 9 months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

The trial requires that you stop using certain medications, such as colchicine, immunosuppressive agents, and systemic corticosteroids, before joining. If you're on these or similar medications, you may need to stop them before participating.

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

Studies have shown that clazakizumab, a medication targeting the protein IL-6, is generally safe. Research on its use for other health issues indicates a good safety record. Some side effects have been reported, but they are usually mild and manageable. Common side effects might include injection site reactions or mild flu-like symptoms. This trial is in the early stages, so while initial results are promising, more research is needed to fully understand clazakizumab's safety for heart-related problems.12345

Why do researchers think this study treatment might be promising?

Most treatments for cardiovascular disease focus on managing symptoms or reducing risk factors like cholesterol and blood pressure. Clazakizumab is unique because it targets a specific protein involved in inflammation called interleukin-6 (IL-6), potentially addressing underlying inflammation that contributes to cardiovascular issues. This mechanism is different from standard treatments, which typically do not target IL-6. Researchers are excited because clazakizumab could offer a new way to reduce cardiovascular risk by directly targeting inflammation, potentially leading to improved outcomes for patients.

What evidence suggests that clazakizumab might be an effective treatment for cardiovascular disease?

Research has shown that clazakizumab, a drug still under investigation, might help reduce inflammation in the body. Inflammation can increase the risk of heart disease. Some studies have examined clazakizumab's effects on heart health and found encouraging results. Clazakizumab targets a molecule that causes inflammation, potentially lowering the risk of heart problems. Although more research is needed for confirmation, early findings suggest it could be a helpful treatment for those at risk of heart issues. Participants in this trial will receive varying doses of clazakizumab or a placebo to further evaluate its effectiveness and safety.16789

Who Is on the Research Team?

C1

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 adults with high inflammation (hsCRP between 2 and 15 mg/L) who have at least one chronic condition like obesity, type 2 diabetes, heart disease, high blood pressure, atherosclerosis, or moderate to severe kidney disease. People with certain infections, recent major surgeries or heart events, uncontrolled health issues, or on specific medications can't join.

Inclusion Criteria

At least one of the following chronic conditions: obesity (body mass index (BMI) ≥30 kg/m2)
I have chronic high blood pressure.
hsCRP ≥2 mg/L and ≤15 mg/L at screening
See 3 more

Exclusion Criteria

I have used steroid medications in the past 14 days.
I am scheduled for heart surgery or another major surgery soon.
My blood pressure is not controlled and is very high.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clazakizumab or placebo subcutaneously to measure the change in hsCRP

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Clazakizumab

Trial Overview

The study tests clazakizumab versus a placebo in adults at risk for cardiovascular events due to chronic conditions and elevated hsCRP. Participants are randomly assigned to receive either the drug or placebo over about nine months to see if clazakizumab lowers inflammation markers.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Clazakizumab Dose 3Experimental Treatment1 Intervention
Group II: Clazakizumab Dose 2Experimental Treatment1 Intervention
Group III: Clazakizumab Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Heart Diseases -- ClinicalTrials.gov

No information is available for this page.

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