Inclisiran Clinical Trials

What Is Inclisiran?

Inclisiran is an FDA-approved medication used as an adjunct to statin therapy for adults with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who need additional lowering of low-density lipoprotein cholesterol (LDL-C). It is administered as a subcutaneous injection. Inclisiran works to lower elevated cholesterol levels, specifically LDL-C, which is a key factor in the development of heart disease. By reducing these cholesterol levels, inclisiran helps to prevent major cardiovascular events such as heart attack and stroke. It is currently being investigated in clinical trials for its effectiveness in managing various conditions related to high cholesterol and cardiovascular health.

Uses and Conditions Under Study

Inclisiran is primarily studied for its role in managing high cholesterol and related cardiovascular conditions. A significant number of trials, totaling 21, focus on hypercholesterolemia and its specific forms. These conditions involve abnormally high levels of cholesterol in the blood, which can lead to plaque buildup in arteries. Inclisiran aims to reduce these elevated cholesterol levels, including in patients with genetic conditions like heterozygous familial hypercholesterolemia and homozygous familial hypercholesterolemia, where high cholesterol is inherited.

Another major area of investigation involves atherosclerotic cardiovascular disease (ASCVD) and related heart conditions, with 18 trials exploring these uses. ASCVD is a condition where plaque builds up inside the arteries, leading to narrowing and hardening, which can result in serious events like heart attacks or strokes. Conditions such as acute coronary syndrome and coronary artery disease also fall into this category. Inclisiran is being studied to see if it can help prevent these cardiovascular events and improve outcomes for patients already affected by these diseases.

Overall, inclisiran has been studied in 46 clinical trials involving a total of 282,128 participants, indicating broad research interest in its potential benefits for cardiovascular health.

Dosing

Inclisiran is administered as a subcutaneous injection. The typical dosing regimen involves an initial dose, followed by a second dose at 3 months (or 90 days), and then subsequent doses every 6 months thereafter. This twice-yearly schedule is a key characteristic of its administration.

Various strengths of inclisiran have been studied in clinical trials. These include:

• 300 mg inclisiran sodium (equivalent to 284 mg inclisiran)
• 200 mg inclisiran sodium
• 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran)

Inclisiran is often studied as an adjunct to standard treatments, such as statins, to further reduce cholesterol levels. Trials have also explored different dosing strategies, including investigations into how inclisiran might be dosed in patients with varying degrees of renal impairment (mild, moderate, or severe) to ensure appropriate and safe use across different patient populations.

Side Effects

In clinical trials for Inclisiran, the most frequently reported side effects were generally similar between patients receiving the drug and those receiving a placebo. Across multiple trials involving over 10,000 patients, some common events were observed:

• Diabetes mellitus was reported in 6.9% of patients taking Inclisiran, compared to 8.4% of patients on placebo.
• Nasopharyngitis (common cold symptoms) occurred in 5.9% of patients on Inclisiran, versus 6.9% on placebo.
• Hypertension (high blood pressure) was observed in 5.6% of patients taking Inclisiran, compared to 6.1% on placebo.
• Arthralgia (joint pain) affected 5.2% of Inclisiran patients, while 5.8% of placebo patients experienced it.
• Back pain was reported in 4.7% of patients on Inclisiran, slightly higher than the 4.2% on placebo.
• Urinary tract infection occurred in 4.2% of Inclisiran patients, compared to 3.8% on placebo.
• Upper respiratory tract infection was seen in 4.1% of Inclisiran patients, versus 5.0% on placebo.
• Myalgia (muscle pain) was reported in 3.2% of patients taking Inclis

  Currently Recruiting Trials

  Researchers are actively recruiting for several clinical trials to further understand inclisiran, a medication designed to lower cholesterol. These studies aim to explore its effectiveness and safety in various patient populations and cardiovascular conditions. Participating in a clinical trial can offer access to new treatments and contribute valuable knowledge to medical science. One significant study, NCT06909565, is a Phase 4 trial enrolling up to 6000 patients. It compares inclisiran to a placebo to prevent major adverse cardiovascular and limb events in individuals who have recently undergone percutaneous coronary or peripheral arterial revascularization. Another Phase 3 trial, NCT07102628, is investigating the effects of starting inclisiran treatment early in patients admitted to the hospital with acute coronary syndromes. This study aims to enroll 300 participants. For those with specific genetic conditions, two Phase 3 trials are focusing on children. Study NCT06597006 is evaluating inclisiran's safety and efficacy in 9 children aged 2 to under 12 years with homozygous familial hypercholesterolemia (HoFH). Similarly, NCT06597019 is studying inclisiran in 51 children aged 6 to under 12 years with heterozygous familial hypercholesterolemia (HeFH). A long-term extension study, NCT05682378, is also open for 195 participants who completed earlier pediatric trials, focusing on inclisiran's long-term safety in HeFH or HoFH. Other trials are exploring inclisiran's role in different aspects of cardiovascular health. NCT06494501, a Phase 3 study with a target enrollment of 1600 individuals, is investigating inclisiran for the primary prevention of coronary artery disease. A Phase 4 study, NCT06372925, is using advanced imaging techniques to evaluate inclisiran's effect on atherosclerotic plaque in 334 patients who have experienced an acute myocardial infarction. Additionally, NCT06865885 is a Phase 4 trial for 100 patients where drug-drug interactions limit traditional LDL-C lowering therapies.

  Where to Participate

  Clinical trials for inclisiran are being conducted across a wide geographic area, making participation accessible to many. There are currently 118 research sites located in 106 cities across 35 states. The top cities with multiple participating sites include:
  • New York, New York (4 sites)
  • San Francisco, California (4 sites)
  • Tomball, Texas (3 sites)
  • Miami Lakes, Florida (3 sites)
  • Salt Lake City, Utah (3 sites)
  • Amarillo, Texas (3 sites)
  • Washington D.C., District of Columbia (3 sites)
  • Boca Raton, Florida (3 sites)
  • Miami, Florida (2 sites)
  • Buffalo, New York (2 sites)
  These studies are open to individuals across a broad age range, from 2 to 100 years old, and welcome participants of all genders. While healthy volunteers are generally not eligible, children are specifically included in several of the ongoing trials.

  Development Timeline

  The journey of inclisiran began with its first clinical trial on February 23, 2017, marking the start of extensive research into its potential. Since then, a total of 46 trials have been initiated, with a remarkable cumulative enrollment of 282,128 participants. The latest trial is projected to conclude by February 2026, indicating ongoing commitment to understanding this medication. Novartis Pharmaceuticals has been a primary driver of inclisiran's development, sponsoring 28 of these trials. Other institutions like The Medicines Company and Duke University have also contributed significantly to the research landscape. The development has progressed through various phases, with 24 trials reaching Phase 3 and 11 trials in Phase 4, demonstrating a strong focus on late-stage evaluation and real-world effectiveness. Initially, early trials explored inclisiran for conditions such as IBS-C and hyperphosphatemia. However, the development pipeline quickly expanded to focus on cardiovascular health, targeting conditions like elevated cholesterol, acute coronary syndrome, and atherosclerotic cardiovascular disease (ASCVD). The research further broadened to include specific genetic forms of high cholesterol, such as heterozygous and homozygous familial hypercholesterolemia, and to investigate its effects on coronary artery disease, plaque stabilization, and LDL-cholesterol lowering. This strategic expansion highlights the drug's evolving role in addressing a wide spectrum of cardiovascular risks.