LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering

Conditions

• Cardiometabolic Syndrome
• Drug Interactions
• LDL-Cholersterol Lowering
• Primary Prevention

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL — DRUG
  The intervention arm will receive subcutaneous injection of inclisiran 284mg at the baseline visit, 3 months and 9 month visit.

Study Details

Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk. There is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.

Key Dates

Start date

Apr 3, 2025

Status verified

Apr 2025

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Standard of Care, no intervention
  Patients will continue the standard of care for lipid lowering as deemed appropriate by their medical team, no changes to lipid lowering therapy are permited during the study.
• Active Comparator: Inclisiran Arm
  Patients in the intervention arm will be treated with a subcutaneous injection of inclisiran 284mg for three doses (baseline visit, 3 months, then 9 month visit) as add-on therapy to the standard of care for lipid lowering as determined by their medical team.

Primary Outcome Measure

Change of LDL-Cholesterol [ Time Frame: 12 months ]

Central Contacts

• Pam Taub, MD
  858-657-8530
  [email protected]
• Antoinette S Birs, MD
  5612817745
  [email protected]

Locations (1)

Find similar trials in La Jolla, CA

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