Health Trials

A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event

ConditionsAtherosclerosisCardiovascular DiseaseObesityHypertensionDiabetes Mellitus, Type 2Renal Insufficiency, Chronic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event.

Participation in the study will last about 9 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

hsCRP ≥2 mg/L and ≤15 mg/L at screening

Established atherosclerotic cardiovascular disease (ASCVD)

Obesity (body mass index (BMI) ≥30 kg/m2)

Type 2 diabetes

Disqualifiers

Acute cardiovascular event within 60 days prior to screening

Acute decompensated heart failure hospitalization within 60 days prior to screening

Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization

New York Heart Association Class III or IV heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clazakizumab

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Clazakizumab Dose 1Experimental treatment 1 intervention
Group B: Clazakizumab Dose 2Experimental treatment 1 intervention
Group C: Clazakizumab Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in hsCRP

Time frame
Baseline, Week 12

Secondary outcomes

1

Percent Change from Baseline in hsCRP

Time frame
Baseline, Week 24
2

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Clazakizumab

Time frame
Day 1 (Week 0) through Week 32

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: