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

Study acronym: SOLVE-LDL-C
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Sep 30, 2026 to Dec 30, 2026 Completion date: Dec 31, 2026 to Mar 31, 2027 · Start date: Apr 3, 2025 to Apr 2, 2025v4 Show 2 more changesShow less
    • Completion date: Dec 31, 2026 to Mar 31, 2027
    • Start date: Apr 3, 2025 to Apr 2, 2025
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 30, 2025 to Apr 3, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 30, 2025 to Apr 3, 2025
  3. Primary endpoint revised Start date: Mar 1, 2025 to Mar 30, 2025 · Eligibility criteria shortened, about 88 words · Secondary endpoint revised · 1 morev2 Show 4 more changesShow less
    • Start date: Mar 1, 2025 to Mar 30, 2025
    • Eligibility criteria shortened, about 88 words
    • Secondary endpoint revised
    • Study description shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06865885
Lead Sponsor University of California, San Diego
Collaborators: Novartis
Conditions Drug Interactions, Primary Prevention, Cardiometabolic Syndrome, LDL-Cholersterol Lowering
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov