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New cholesterol shot shows promise in large trial

NCT ID NCT05192941

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 4 trial tested the drug inclisiran (given as a shot under the skin) against a placebo in 1770 adults with high cholesterol who were already on cholesterol-lowering therapy. The goal was to see if inclisiran helps more people reach their LDL cholesterol targets. The study also looked at safety and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inclisiran (a drug injected under the skin to lower cholesterol)
What this could lead to
If it works, this could provide a new, convenient treatment option for people with high cholesterol who need to lower their heart disease risk.
What could go wrong
This is a completed Phase 4 trial, so results are known. However, inclisiran may not work for everyone, and side effects like muscle pain are possible. It is not a cure, just a way to manage cholesterol.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,770 people

The number who actually took part.

Started

Apr 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male or female participants ≥18 years of age. 3. Participants categorized as very high or high CV risk, as defined below: •Very high risk participants with at least one of the following: A. Documented Atherosclerotic Cardiovascular Disease (ASCVD) i) Acute Coronary Syndrome: Unstable angina or myocardial infarction ii) Stable angina iii) Unequivocally documented ASCVD upon prior imaging v) Stroke and Transient Ischaemic Attack (TIA) vi) Peripheral Artery Disease (PAD) B. Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least ≥ 3 major risk factors, or early onset of Type 1 DM of long duration (\> 20 years) C. A calculated SCORE2 ≥ 7.5% for age \< 50 years; SCORE2 ≥ 10% for age 50-69 years; SCORE2-OP ≥ 15% for age ≥ 70 years to estimate 10-year risk of fatal and non-fatal CVD D. Pre-existing diagnosis of heterozygous familial hypercholesterolemia (HeFH) with ASCVD or with another major risk factor. OR •High risk participants with at least one of the following: A. Markedly elevated single risk factors, in particular total cholesterol \> 310 mg/dL, LDL-C \> 190 mg/dL, or blood pressure ≥ 180/110 mmHg B. Pre-existing diagnosis of HeFH without other major risk factors C. DM without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration ≥ 10 years or other additional risk factor D. Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2) E. A calculated SCORE2 2.5 to \<7.5% for age under 50 years; SCORE2 5 to \<10% for age 50-69 years; SCORE2-OP 7.5 to \<15% for age ≥70 years to estimate 10-year risk of fatal and non-fatal CVD as defined by the cardiovascular risk categories in the 2019 ESC/EAS guideline (Mach et al 2020) 4. LDL-C levels: 1. in participants with very high cardiovascular risk: serum LDL-C ≥55 mg/dL 2. in participants with high cardiovascular risk: serum LDL-C ≥70 mg/dL 5. Participant on a stable dose of a statin for ≥ 30 days. 6. Up to approximately 20% of total participants can be on a stable dose (for ≥ 30 days prior to screening) of another LLT on top of statin such as a cholesterol absorbing inhibitor or a bile acid sequestrant, or alternatively, an adenosine triphosphate citrate lyase (ACL) inhibitor, as indicated. 7. Fasting triglyceride \< 400 mg/dL. At Baseline: 8. Fasting triglyceride \< 400 mg/dL. 9. Before randomization, despite being treated with the individual MTD of a statin for ≥ 30 days and, if applicable, with another LLT on top of statin (stable for ≥ 30 days), 1. in participants with very high cardiovascular risk: serum LDL-C ≥ 55mg/dL. 2. in participants with high cardiovascular risk: serum LDL-C ≥ 70mg/dL. Key Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. 1. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 2 years at screening or baseline visit. 2. Participants on more than one other lipid-lowering drug on top of statin at screening visit. 3. Pre-existing diagnosis of homozygous familial hypercholesterolemia at screening or baseline visit. 4. Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome at screening or baseline visit. 5. Previous (within 90 days of screening), current or planned treatment with a monoclonal antibody (mAb) directed towards PCSK9 (e.g. evolocumab, alirocumab) at screening or baseline visit. 6. Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within 2 years prior to screening or baseline visit. 7. Previous, current or planned treatment with LDL-apheresis at screening or baseline visit. 8. Participants with known intolerance to rosuvastatin at screening or baseline visit. 9. History of hypersensitivity to any of the study treatments, inclisiran or rosuvastatin, or its excipients or to drugs of similar chemical classes at screening or baseline visit. 10. Participants taking gemfibrozil at screening or baseline visit. 11. Liver and CK: (a) Active liver disease defined as any current infectious, neoplastic, or metabolic pathology of the liver or (b) unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \> 2x ULN (except for participants with Gilbert's syndrome), or (c) creatine kinase (CK) \>5x ULN at screening or baseline visit. 12. Participant with severe renal impairment defined by eGFR \<30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at screening or baseline visit. 13. Acute coronary syndrome, ischemic stroke or TIA, coronary revascularization or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 3 months prior to the screening or baseline visit. 14. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization within the study duration. 15. Heart failure New York Heart Association (NYHA) class IV at screening or baseline visit. 16. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy (excluding systemic adjuvant therapies given to prevent cancer recurrence eg: hormonotherapy for prostate or breast cancer) during the 3 years prior to screening or baseline visit. 17. Participant with myopathy at screening or baseline visit. 18. Participant receiving concomitant ciclosporin at screening or baseline visit. 19. Participants that are predisposed to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). 20. Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose-malabsorption. 21. Unwillingness or inability (e.g. physical or cognitive) to comply with study procedures (including study visits, fasting blood draws and compliance with study treatment regimens), and medication administration (injections) and schedule. Participant should be able and willing to read, understand and answer questionnaires. 22. Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study at screening or baseline visit. 23. Use of other investigational drugs within 5 half-lives, 30 days or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer or longer if required by local regulation, prior to screening visit. 24. Pregnant or nursing (lactating) women at screening or baseline visit. 25. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment, which includes rosuvastatin, and for 5 days (= 5 times the terminal half-life of rosuvastatin) after stopping medication. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. * Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. * Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms). Women are considered not of child bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessments and she is considered not of child bearing potential. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the local ICF.

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Conditions

The condition(s) this trial relates to.

Angina Pectoris cardiovascular disorder Dyslipidemias Hypercholesterolemia hyperlipidemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Sofia, Bulgaria, 1202, Bulgaria

  • Novartis Investigative Site

    Burgas, Burgas, 8000, Bulgaria

  • Novartis Investigative Site

    Burgas, 8001, Bulgaria

  • Novartis Investigative Site

    Gabrovo, 5300, Bulgaria

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Plovdiv, 4002, Bulgaria

  • Novartis Investigative Site

    Rousse, 7000, Bulgaria

  • Novartis Investigative Site

    Sofia, 1233, Bulgaria

  • Novartis Investigative Site

    Sofia, 1606, Bulgaria

  • Novartis Investigative Site

    Sofia, 1618, Bulgaria

  • Novartis Investigative Site

    Stara Zagora, 6000, Bulgaria

  • Novartis Investigative Site

    Varna, 9010, Bulgaria

  • Novartis Investigative Site

    Veliko Tarnovo, 5000, Bulgaria

  • Novartis Investigative Site

    Chlumec nad Cidlinou, Chlumec Nad Cidlinou, 503 51, Czechia

  • Novartis Investigative Site

    Přerov, Olomouc Region, 750 02, Czechia

  • Novartis Investigative Site

    Hlučín, 748 01, Czechia

  • Novartis Investigative Site

    Hodonín, 695 01, Czechia

  • Novartis Investigative Site

    Mělník, 276 01, Czechia

  • Novartis Investigative Site

    Olomouc, 772 00, Czechia

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Pardubice, 532 03, Czechia

  • Novartis Investigative Site

    Slaný, 274 01, Czechia

  • Novartis Investigative Site

    Trutnov, 460 63, Czechia

  • Novartis Investigative Site

    Pärnu, 80018, Estonia

  • Novartis Investigative Site

    Tallinn, 10138, Estonia

  • Novartis Investigative Site

    Tallinn, 13419, Estonia

  • Novartis Investigative Site

    Tartu, 50406, Estonia

  • Novartis Investigative Site

    Amiens, 80054, France

  • Novartis Investigative Site

    Chambéry, 73000, France

  • Novartis Investigative Site

    Le Chesnay, 78150, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Lille, 59000, France

  • Novartis Investigative Site

    Marseille, 13005, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Valenciennes, 59300, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70376, Germany

  • Novartis Investigative Site

    Lichtenfels, Bavaria, 96215, Germany

  • Novartis Investigative Site

    Muehldorf Am Inn, Bavaria, 84453, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Nuremberg, Bavaria, 90402, Germany

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60594, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 65929, Germany

  • Novartis Investigative Site

    Langen, Hesse, 63225, Germany

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37075, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30449, Germany

  • Novartis Investigative Site

    Winsen, Lower Saxony, 21423, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 51065, Germany

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45355, Germany

  • Novartis Investigative Site

    Löhne, North Rhine-Westphalia, 32584, Germany

  • Novartis Investigative Site

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

  • Novartis Investigative Site

    Saint Ingbert, Saarland, 66386, Germany

  • Novartis Investigative Site

    Bad Gottleuba, Saxony, 01816, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01099, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Schleswig, Schleswig-Holstein, 24837, Germany

  • Novartis Investigative Site

    Bad Homburg, 61348, Germany

  • Novartis Investigative Site

    Bad Krozingen, 79189, Germany

  • Novartis Investigative Site

    Bad Oeynhausen, 32545, Germany

  • Novartis Investigative Site

    Bamberg, 96049, Germany

  • Novartis Investigative Site

    Berlin, 10367, Germany

  • Novartis Investigative Site

    Berlin, 10559, Germany

  • Novartis Investigative Site

    Berlin, 10787, Germany

  • Novartis Investigative Site

    Berlin, 10789, Germany

  • Novartis Investigative Site

    Berlin, 13347, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Bochum, 44789, Germany

  • Novartis Investigative Site

    Bremen, 28277, Germany

  • Novartis Investigative Site

    Coburg, 96450, Germany

  • Novartis Investigative Site

    Cologne, 51069, Germany

  • Novartis Investigative Site

    Dessau, 06846, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Duisburg, 47051, Germany

  • Novartis Investigative Site

    Erfurt, 99089, Germany

  • Novartis Investigative Site

    Erfurt, 99097, Germany

  • Novartis Investigative Site

    Essen, 45277, Germany

  • Novartis Investigative Site

    Essen, 45355, Germany

  • Novartis Investigative Site

    Essen, 45359, Germany

  • Novartis Investigative Site

    Fulda, 36037, Germany

  • Novartis Investigative Site

    Gelnhausen, 63571, Germany

  • Novartis Investigative Site

    Gladbeck, 45968, Germany

  • Novartis Investigative Site

    Hamburg, 22041, Germany

  • Novartis Investigative Site

    Hamburg, 22607, Germany

  • Novartis Investigative Site

    Haßloch, 67454, Germany

  • Novartis Investigative Site

    Hennigsdorf, 16761, Germany

  • Novartis Investigative Site

    Hoyerswerda, 02977, Germany

  • Novartis Investigative Site

    Kassel, 34121, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Lüneburg, 21339, Germany

  • Novartis Investigative Site

    Magdeburg, 39110, Germany

  • Novartis Investigative Site

    Magdeburg, 39120, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Mannheim, 68165, Germany

  • Novartis Investigative Site

    Markkleeberg, 04416, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Papenburg, 26871, Germany

  • Novartis Investigative Site

    Pirna, 01796, Germany

  • Novartis Investigative Site

    Potsdam, 14471, Germany

  • Novartis Investigative Site

    Reinfeld, 23858, Germany

  • Novartis Investigative Site

    Rostock, 18057, Germany

  • Novartis Investigative Site

    Rüdersdorf, 15562, Germany

  • Novartis Investigative Site

    Singen, 78224, Germany

  • Novartis Investigative Site

    Stuttgart, 70378, Germany

  • Novartis Investigative Site

    Wallerfing, 94574, Germany

  • Novartis Investigative Site

    Warendorf, 48231, Germany

  • Novartis Investigative Site

    Wuppertal, 42117, Germany

  • Novartis Investigative Site

    Daugavpils, LV-5417, Latvia

  • Novartis Investigative Site

    Ogre, 5001, Latvia

  • Novartis Investigative Site

    Riga, 1012, Latvia

  • Novartis Investigative Site

    Riga, LV 1002, Latvia

  • Novartis Investigative Site

    Riga, LV-1001, Latvia

  • Novartis Investigative Site

    Riga, LV-1012, Latvia

  • Novartis Investigative Site

    Krosno, Krosno, 38-400, Poland

  • Novartis Investigative Site

    Krakow, Maloposkie, 31-271, Poland

  • Novartis Investigative Site

    Szczecin, West Pomeranian Voivodeship, 71-528, Poland

  • Novartis Investigative Site

    Gdynia, 81-157, Poland

  • Novartis Investigative Site

    Katowice, 40-648, Poland

  • Novartis Investigative Site

    Krakow, 31-216, Poland

  • Novartis Investigative Site

    Rzeszów, 35-055, Poland

  • Novartis Investigative Site

    Skierniewice, 96-100, Poland

  • Novartis Investigative Site

    Tarnów, 33-100, Poland

  • Novartis Investigative Site

    Málaga, Andalusia, 29009, Spain

  • Novartis Investigative Site

    Seville, Andalusia, 41014, Spain

  • Novartis Investigative Site

    Sanlucar Barrameda, Cadiz, 11540, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative Site

    San Sebastian Reyes, Madrid, 28702, Spain

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

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