Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support

• Status: Recruiting
• Trial end date: 2022-09-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to find out if a study treatment called Inclisiran can be given in regional primary care setting (i.e. at a GP surgery in the NHS) in the UK, and to understand how this health care service may be set-up by the NHS.

Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol (LDL-cholesterol) in the blood. Inclisiran works in a way that makes the liver produce less of a substance called 'PCSK9'. PCSK9 reduces the ability of the liver to remove LDL-cholesterol from the blood. By lowering the production of PCSK9, Inclisiran leads to more LDL-cholesterol being removed by the liver from the blood, thereby reducing LDL-cholesterol overall.

About 900 patients will participate in this study, at about 20 GP surgeries across the Greater Manchester area within the UK.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.

2. Patients on established lipid lowering medication or, have been recommended lipid lowering therapy by their health care provider but are unable to tolerate treatment.

3. A total cholesterol measurement at screening that is ≥4 mmol/L [approximately 160 mg/dL].

4. Participants on lipid-lowering therapies should be on a stable dose for ≥30 days before screening with no planned medication or dose change.

Exclusion Criteria:

1. Medical or surgical history that might limit the individual's ability to take study treatments for the duration of the study and/or put the participant at significant risk .

2. Current or planned renal dialysis or transplantation.

3. Acute coronary syndrome or stroke less than 4 weeks before the screening visit.

4. Coronary revascularization procedure planned within the next 6 months.

5. Women of child-bearing potential, unless they agree to abstinence or, if sexually active, agree to the use of effective methods of contraception during the study.

6. Women who are pregnant or breast-feeding.

7. Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran.

8. Previous exposure to inclisiran or participation in a randomised study of inclisiran.

9. Current or previous participation in a clinical study with an unlicensed drug or device within 30 days or five half-lives of the screening visit, whichever is longer.

10. Participants who plan to move away from the geographical area where the study is being conducted during the study period.

Other protocol-defined inclusion/exclusion criteria may apply.