Drug InteractionsPhase 4SOLVE-LDL-CNCT06865885
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
A Phase 4 study testing Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL in people with Drug Interactions and Primary Prevention, run by University of California, San Diego at 1 site in United States.
Trial summary
Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drug Interactions, Primary Prevention, Cardiometabolic Syndrome
- What is being tested?
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study, including potential randomization to injections.
- Age >18 and <85 years and able to provide self-consent.
- Taking five or more prescription drugs at the time of enrollment, of any type.
- Meets at least one of the following criteria:
- Elevated 10-year ASCVD risk score ≥7.5% (based on the ACC/AHA ASCVD Risk Estimator Plus tool).
Show all 15Show fewer
- Evidence of subclinical atherosclerosis including:
- Calcification in any vascular bed, including coronary arteries and aorta. Calcification of cardiac valves. Breast calcification. Carotid plaque that is not hemodynamically significant.
- o Type II diabetes on a stable medical regimen with HbA1c <8.5%. Per American Diabetes Association guidelines, patients with Type II diabetes aged 40-75 years should be on a moderate-intensity statin.
- Patients with documented partial or complete statin intolerance are eligible for enrollment.
- On maximally tolerated statin therapy (which can be no statin for patients with documented intolerance) and have suboptimal LDL levels:
- For patients with Type II diabetes: LDL >70 mg/dL or non-HDL >120 mg/dL.
- For other patients: LDL >90 mg/dL or non-HDL >120 mg/dL.
- Willing to adhere to the randomized study regimen, including subcutaneous injection of inclisiran.
- Agreement to adhere to lifestyle considerations (see Section 5.3) throughout the study duration.
Who cannot join
- Prior or current use of inclisiran.
- Known hypersensitivity or allergy to inclisiran or its components.
- Active liver disease or unexplained persistent elevations in liver enzymes (ALT or AST >3x upper limit of normal).
- History of rhabdomyolysis or severe muscle-related statin intolerance.
- Uncontrolled diabetes (HbA1c >8.5%).
- Active malignancy requiring systemic therapy.
Show all 10Show fewer
- Recent major cardiovascular event (myocardial infarction, stroke, or hospitalization for unstable angina) within the past 3 months.
- History of organ transplant other than solid-organ transplant.
- Pregnancy or breastfeeding.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC San Diego Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Marissa Dzotsi, MPH, 858-534-8234, mfdzotsi@health.ucsd.edu
Lauren Harris, 858-246-2406, lnharris@health.ucsd.edu
About this study
Official title: 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
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.
Read the detailed description
This is an investigator-initiated, single-site, open-label, randomized trial. The investigators will enroll up to 100 high-risk primary prevention patients with at least one comorbidity and an indication for additional lipid control (such as Type II diabetes with A1c ≤ 8.5%, subclinical atherosclerosis, or ASCVD risk of 7.5% or greater). Patients will be randomized 1:1 to the inclisiran arm (n ≥ 50) with standard of care or standard of care alone (n ≥ 50).
The study will consist of five study visits (screening, baseline, 3 months, 9 months, and 12 months). Patients in the inclisiran arm will receive a subcutaneous injection of inclisiran 284 mg for three doses (baseline, 3 months, and 9 months following randomization) as add-on therapy. LDL-C (the primary endpoint) along with other biomarkers will be measured at screening, baseline (inclisiran dose #1), 3 months (inclisiran dose #2), 9 months (inclisiran dose #3), and 12 months (labs only). Patients will also undergo medical history and medication review at each visit. Surveys will be completed at each visit during the study period.
Patients in the control arm (standard of care) will continue with their current lipid-lowering therapy. No adjustments will be made to lipid-lowering therapy during the course of the study. Participants will be aware of the group to which they have been randomized.
The primary objective is to determine the efficacy of inclisiran for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, autoimmune disease, liver disease, chronic kidney disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.
- Conditions
- Drug Interactions, Primary Prevention, Cardiometabolic Syndrome, LDL-Cholersterol Lowering
- Being tested
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Keywords
- Statin intolerance, drug drug interaction, inclisiran, LDL-Cholesterol, polypharmacy, multiple comorbidities
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLDrug
The intervention arm will receive subcutaneous injection of inclisiran 284mg at the baseline visit, 3 months and 9 month visit.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care, no intervention | 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. |
| Inclisiran Arm | Active comparator | 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. Receives: Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of LDL-Cholesterol
Percent Change in LDL-C from baseline to month 12 of treatment with inclisiran as add on to background lipid-lowering therapy that includes maximally tolerated statin.
Measured: 12 months
Secondary outcomes (1)
Change in Atherogenic Lipid Burden
Absolute and percent change in LDL particle number, apo B, non-HDL, and small dense LDL, lipoprotein(a), from baseline (Visit 1) to month 12 of treatment with inclisiran
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start2 Apr 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to the inclisiran arm (n=50) or will continue with standard of care (n=50). The study will consist of 5 study visits (screening, baseline, 3 mo., 9 mo., and 12 mo.). Patients in the inclisiran arm will be treated with subcutaneous injection of inclisiran 284mg (baseline, 3 months, then 9 month visit) as add-on therapy to SOC lipid-lowering therapies. LDL-C (primary endpoint) along with other biomarkers will be measured at screening, baseline, 3 mo., 9 mo., and 12 months.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Michael Wilkinson, MD, Study director, University of California, San DiegoEric D Adler, MD, Study chair, University of California, San DiegoPam Taub, MD, Principal investigator, University of California, San DiegoAntoinette Birs, MD, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865885
- Sponsor's protocol ID
- 810920
- Other IDs
- 315668-00001
- Acronym
- SOLVE-LDL-C
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) is not expected to be shared due to privacy concerns, institutional policies, and regulatory considerations. However, the Principal Investigator may determine that certain de-identified data may be shared with other researchers on a case-by-case basis, subject to appropriate approvals and data use agreements.
Publications
Wright RS, Ray KK, Raal FJ, Kallend DG, Jaros M, Koenig W, Leiter LA, Landmesser U, Schwartz GG, Friedman A, Wijngaard PLJ, Garcia Conde L, Kastelein JJP; ORION Phase III Investigators. Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis. J Am Coll Cardiol. 2021 Mar 9;77(9):1182-1193. doi: 10.1016/j.jacc.2020.12.058.
PubMed 33663735Budoff MJ, Kinninger A, Gransar H, Achenbach S, Al-Mallah M, Bax JJ, Berman DS, Cademartiri F, Callister TQ, Chang HJ, Chow BJW, Cury RC, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Leipsic J, Lin FY, Kim YJ, Marques H, Pontone G, Rubinshtein R, Shaw LJ, Villines TC, Min JK; CONFIRM Investigators. When Does a Calcium Score Equate to Secondary Prevention?: Insights From the Multinational CONFIRM Registry. JACC Cardiovasc Imaging. 2023 Sep;16(9):1181-1189. doi: 10.1016/j.jcmg.2023.03.008. Epub 2023 May 24.
PubMed 37227328American Diabetes Association Professional Practice Committee. 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S179-S218. doi: 10.2337/dc24-S010.
PubMed 38078592Iribarren C, Chandra M, Lee C, Sanchez G, Sam DL, Azamian FF, Cho HM, Ding H, Wong ND, Molloi S. Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013526. doi: 10.1161/CIRCIMAGING.121.013526. Epub 2022 Mar 15.
PubMed 35290077Fox CS, Vasan RS, Parise H, Levy D, O'Donnell CJ, D'Agostino RB, Benjamin EJ; Framingham Heart Study. Mitral annular calcification predicts cardiovascular morbidity and mortality: the Framingham Heart Study. Circulation. 2003 Mar 25;107(11):1492-6. doi: 10.1161/01.cir.0000058168.26163.bc.
PubMed 12654605Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
PubMed 10403851Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.
PubMed 32187462Raal FJ, Kallend D, Ray KK, Turner T, Koenig W, Wright RS, Wijngaard PLJ, Curcio D, Jaros MJ, Leiter LA, Kastelein JJP; ORION-9 Investigators. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Apr 16;382(16):1520-1530. doi: 10.1056/NEJMoa1913805. Epub 2020 Mar 18.
PubMed 32197277Wiggins BS, Saseen JJ, Page RL 2nd, Reed BN, Sneed K, Kostis JB, Lanfear D, Virani S, Morris PB; American Heart Association Clinical Pharmacology Committee of the Council on Clinical Cardiology; Council on Hypertension; Council on Quality of Care and Outcomes Research; and Council on Functional Genomics and Translational Biology. Recommendations for Management of Clinically Significant Drug-Drug Interactions With Statins and Select Agents Used in Patients With Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2016 Nov 22;134(21):e468-e495. doi: 10.1161/CIR.0000000000000456. Epub 2016 Oct 17. No abstract available.
PubMed 27754879Hughes JE, Waldron C, Bennett KE, Cahir C. Prevalence of Drug-Drug Interactions in Older Community-Dwelling Individuals: A Systematic Review and Meta-analysis. Drugs Aging. 2023 Feb;40(2):117-134. doi: 10.1007/s40266-022-01001-5. Epub 2023 Jan 24.
PubMed 36692678Moran CA, Collins LF, Beydoun N, Mehta PK, Fatade Y, Isiadinso I, Lewis TT, Weber B, Goldstein J, Ofotokun I, Quyyumi A, Choi MY, Titanji K, Lahiri CD. Cardiovascular Implications of Immune Disorders in Women. Circ Res. 2022 Feb 18;130(4):593-610. doi: 10.1161/CIRCRESAHA.121.319877. Epub 2022 Feb 17.
PubMed 35175848
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06865885
- Acronym / sponsor ID
- SOLVE-LDL-C / 810920
- Conditions
- Drug Interactions, Primary Prevention, Cardiometabolic Syndrome, LDL-Cholersterol Lowering
- Keywords
- Statin intolerance, drug drug interaction, inclisiran, LDL-Cholesterol, polypharmacy, multiple comorbidities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an investigator-initiated, single-site, open-label, randomized trial. The investigators will enroll up to 100 high-risk primary prevention patients with at least one comorbidity and an indication for additional lipid control (such as Type II diabetes with A1c ≤ 8.5%, subclinical atherosclerosis, or ASCVD risk of 7.5% or greater). Patients will be randomized 1:1 to the inclisiran arm (n ≥ 50) with standard of care or standard of care alone (n ≥ 50).
The study will consist of five study visits (screening, baseline, 3 months, 9 months, and 12 months). Patients in the inclisiran arm will receive a subcutaneous injection of inclisiran 284 mg for three doses (baseline, 3 months, and 9 months following randomization) as add-on therapy. LDL-C (the primary endpoint) along with other biomarkers will be measured at screening, baseline (inclisiran dose #1), 3 months (inclisiran dose #2), 9 months (inclisiran dose #3), and 12 months (labs only). Patients will also undergo medical history and medication review at each visit. Surveys will be completed at each visit during the study period.
Patients in the control arm (standard of care) will continue with their current lipid-lowering therapy. No adjustments will be made to lipid-lowering therapy during the course of the study. Participants will be aware of the group to which they have been randomized.
The primary objective is to determine the efficacy of inclisiran for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, autoimmune disease, liver disease, chronic kidney disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to the inclisiran arm (n=50) or will continue with standard of care (n=50). The study will consist of 5 study visits (screening, baseline, 3 mo., 9 mo., and 12 mo.). Patients in the inclisiran arm will be treated with subcutaneous injection of inclisiran 284mg (baseline, 3 months, then 9 month visit) as add-on therapy to SOC lipid-lowering therapies. LDL-C (primary endpoint) along with other biomarkers will be measured at screening, baseline, 3 mo., 9 mo., and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care, no intervention | 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. |
| Inclisiran Arm | Active comparator | Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study, including potential randomization to injections.
- Age >18 and <85 years and able to provide self-consent.
- Taking five or more prescription drugs at the time of enrollment, of any type.
- Meets at least one of the following criteria:
Key exclusion criteria (10 listed)
- Prior or current use of inclisiran.
- Known hypersensitivity or allergy to inclisiran or its components.
- Active liver disease or unexplained persistent elevations in liver enzymes (ALT or AST >3x upper limit of normal).
- History of rhabdomyolysis or severe muscle-related statin intolerance.
- Uncontrolled diabetes (HbA1c >8.5%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLThe intervention arm will receive subcutaneous injection of inclisiran 284mg at the baseline visit, 3 months and 9 month visit. | Drug | Inclisiran Arm |
Primary outcome
Change of LDL-Cholesterol
Time frame: 12 months
Percent Change in LDL-C from baseline to month 12 of treatment with inclisiran as add on to background lipid-lowering therapy that includes maximally tolerated statin.
1 secondary outcome
Change in Atherogenic Lipid Burden
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 33663735Wright RS, Ray KK, Raal FJ, Kallend DG, Jaros M, Koenig W, Leiter LA, Landmesser U, Schwartz GG, Friedman A, Wijngaard PLJ, Garcia Conde L, Kastelein JJP; ORION Phase III Investigators. Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis. J Am Coll Cardiol. 2021 Mar 9;77(9):1182-1193. doi: 10.1016/j.jacc.2020.12.058.
- Background: PubMed 37227328Budoff MJ, Kinninger A, Gransar H, Achenbach S, Al-Mallah M, Bax JJ, Berman DS, Cademartiri F, Callister TQ, Chang HJ, Chow BJW, Cury RC, Feuchtner G, Hadamitzky M, Hausleiter J, Kaufmann PA, Leipsic J, Lin FY, Kim YJ, Marques H, Pontone G, Rubinshtein R, Shaw LJ, Villines TC, Min JK; CONFIRM Investigators. When Does a Calcium Score Equate to Secondary Prevention?: Insights From the Multinational CONFIRM Registry. JACC Cardiovasc Imaging. 2023 Sep;16(9):1181-1189. doi: 10.1016/j.jcmg.2023.03.008. Epub 2023 May 24.
- Background: PubMed 38078592American Diabetes Association Professional Practice Committee. 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S179-S218. doi: 10.2337/dc24-S010.
- Background: PubMed 35290077Iribarren C, Chandra M, Lee C, Sanchez G, Sam DL, Azamian FF, Cho HM, Ding H, Wong ND, Molloi S. Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women. Circ Cardiovasc Imaging. 2022 Mar;15(3):e013526. doi: 10.1161/CIRCIMAGING.121.013526. Epub 2022 Mar 15.
- Background: PubMed 12654605Fox CS, Vasan RS, Parise H, Levy D, O'Donnell CJ, D'Agostino RB, Benjamin EJ; Framingham Heart Study. Mitral annular calcification predicts cardiovascular morbidity and mortality: the Framingham Heart Study. Circulation. 2003 Mar 25;107(11):1492-6. doi: 10.1161/01.cir.0000058168.26163.bc.
- Background: PubMed 10403851Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
- Background: PubMed 32187462Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18.
- Background: PubMed 32197277Raal FJ, Kallend D, Ray KK, Turner T, Koenig W, Wright RS, Wijngaard PLJ, Curcio D, Jaros MJ, Leiter LA, Kastelein JJP; ORION-9 Investigators. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Apr 16;382(16):1520-1530. doi: 10.1056/NEJMoa1913805. Epub 2020 Mar 18.
- Background: PubMed 27754879Wiggins BS, Saseen JJ, Page RL 2nd, Reed BN, Sneed K, Kostis JB, Lanfear D, Virani S, Morris PB; American Heart Association Clinical Pharmacology Committee of the Council on Clinical Cardiology; Council on Hypertension; Council on Quality of Care and Outcomes Research; and Council on Functional Genomics and Translational Biology. Recommendations for Management of Clinically Significant Drug-Drug Interactions With Statins and Select Agents Used in Patients With Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2016 Nov 22;134(21):e468-e495. doi: 10.1161/CIR.0000000000000456. Epub 2016 Oct 17. No abstract available.
- Background: PubMed 36692678Hughes JE, Waldron C, Bennett KE, Cahir C. Prevalence of Drug-Drug Interactions in Older Community-Dwelling Individuals: A Systematic Review and Meta-analysis. Drugs Aging. 2023 Feb;40(2):117-134. doi: 10.1007/s40266-022-01001-5. Epub 2023 Jan 24.
- Background: PubMed 35175848Moran CA, Collins LF, Beydoun N, Mehta PK, Fatade Y, Isiadinso I, Lewis TT, Weber B, Goldstein J, Ofotokun I, Quyyumi A, Choi MY, Titanji K, Lahiri CD. Cardiovascular Implications of Immune Disorders in Women. Circ Res. 2022 Feb 18;130(4):593-610. doi: 10.1161/CIRCRESAHA.121.319877. Epub 2022 Feb 17.
- Individual participant dataSharing planned: No. Individual participant data (IPD) is not expected to be shared due to privacy concerns, institutional policies, and regulatory considerations. However, the Principal Investigator may determine that certain de-identified data may be shared with other researchers on a case-by-case basis, subject to appropriate approvals and data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Wilkinson, MD study director
University of California, San Diego
Eric D Adler, MD study chair
University of California, San Diego
Pam Taub, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL in people with Drug Interactions and Primary Prevention, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pam Taub, MD (858-657-8530, ptaub@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of LDL-Cholesterol (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06865885, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.