Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis.
R Scott Wright, Kausik K Ray, Frederick J Raal...
https://pubmed.ncbi.nlm.nih.gov/33663735Actively Recruiting
Phase 4
Age: 18Years - 85Years
All Genders
ID06865885
Study of Optimal LDL-C Value Enhancement With Inclisiran in Patients With Multiple Comorbidities in Which There Are Drug-Drug Interactions Limiting LDL-C Lowering
Led by University of California, San Diego · Updated on 2025-04-11
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of inclisiran, a subcutaneous injection, combined with standard care to lower LDL cholesterol in high-risk patients who have multiple health conditions and take many medications. These patients, often with autoimmune or rheumatologic disorders, face challenges in optimizing statin therapy due to drug interactions, leading to higher cardiovascular risk despite current treatments. This randomized, open-label Phase 4 trial focuses on patients with conditions like Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, or those who have had solid-organ transplants and are on complex medication regimens. The study will enroll up to 100 participants, randomly assigning them to two groups: one receiving standard care alone and the other receiving three doses of inclisiran injections at baseline, 3 months, and 9 months alongside standard care. The control group continues their current lipid-lowering therapy without changes. The study includes five visits over 12 months: screening, baseline, 3 months, 9 months, and 12 months, with monitoring of LDL cholesterol and other biomarkers at each timepoint. Participants will undergo medical history and medication reviews, blood tests for LDL cholesterol levels, and complete surveys during each visit. The primary outcome is the change in LDL cholesterol after 12 months. Safety monitoring and adherence to treatment and lifestyle recommendations will be maintained throughout. This study aims to find better ways to manage cholesterol in patients who cannot fully benefit from statins due to drug-drug interactions.
CONDITIONS
Brief Title
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with all study procedures and available for the study duration, including possible injections.
- Age greater than 18 and less than 85 years and able to provide self-consent.
- Taking five or more prescription medications at enrollment.
- Meets at least one of the following: elevated 10-year ASCVD risk score ≥7.5%, evidence of subclinical atherosclerosis, or Type II diabetes on stable regimen with HbA1c <8.5%.
- Patients with documented partial or complete statin intolerance are eligible.
- On maximally tolerated statin therapy or no statin if intolerant, with suboptimal LDL levels (LDL >70 mg/dL or non-HDL >120 mg/dL for diabetes; LDL >90 mg/dL or non-HDL >120 mg/dL for others).
- Willing to adhere to randomized study regimen including subcutaneous inclisiran injection.
- Agreement to follow lifestyle considerations during the study.
You will not qualify if you...
- Prior or current use of inclisiran.
- Known allergy or hypersensitivity to inclisiran or its components.
- Active liver disease or unexplained liver enzyme elevations greater than three times normal.
- History of rhabdomyolysis or severe muscle-related statin intolerance.
- Uncontrolled diabetes (HbA1c >8.5%).
- Active cancer requiring systemic treatment.
- Major cardiovascular event within past 3 months.
- History of organ transplant other than solid-organ transplant.
- Pregnancy or breastfeeding.
- Any condition making participation unsafe or interfering with study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants in the inclisiran arm receive subcutaneous injections of inclisiran 284 mg at baseline, 3 months, and 9 months as add-on therapy to their lipid-lowering regimen. Participants in the standard of care arm continue their existing lipid-lowering therapy without changes. Medical history, medication review, and surveys are completed at each visit.
5 visits (baseline, 3 months, 9 months, 12 months, plus screening)
Trial Site Locations
Total: 1 location
1
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92037
Actively Recruiting
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Research Team
P
Pam Taub, MD
A
Antoinette S Birs, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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