Clazakizumab for Cardiovascular Disease
(CLARITY-CRP 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive clazakizumab or placebo subcutaneously to measure the change in hsCRP
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive clazakizumab SC
Participants will receive clazakizumab SC
Participants will receive clazakizumab subcutaneously (SC)
Participants will receive placebo SC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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.
clinicaltrials.gov
clinicaltrials.gov/ct2/results?cond=Heart+Diseases&term=&cntry=&state=&city=&dist=Heart Diseases -- ClinicalTrials.gov
No information is available for this page.
2.
clinicaltrial.be
clinicaltrial.be/nl/details/190863?per_page=100&country=Belgium&only_recruiting=1&only_eligible=0&only_active=0Combined Dose-Finding and CV Outcomes Study With ...
(Clazakizumab) Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety
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6.
ctv.veeva.com
ctv.veeva.com/study/clazakizumab-for-the-treatment-of-chronic-active-antibody-mediated-rejection-in-kidney-transplant-reClazakizumab for the Treatment of Chronic Active Antibody ...
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of ...
Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 ...
This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors. Cardiovascular outcomes, ...
Csl300 clinical trials - Research.Patient.info
(Clazakizumab) It aims to see if CSL300 can improve heart health and is safe, especially for those with existing heart conditions or diabetes.
Study Details | NCT03552575 | The Effects of Sacubitril/ ...
reduced the risk of heart failure hospitalisation and death in patients with HF-REF. reduce the risk of cardiovascular events in patients with chronic heart ...
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