Primary Hypercholesterolemia or Mixed DyslipidemiaPhase 3V-Mono ChinaNCT05888103
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
A Phase 3 study testing Inclisiran in people with Primary Hypercholesterolemia or Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 28 sites in China.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Hypercholesterolemia or Mixed Dyslipidemia
- What is being tested?
- Inclisiran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 28 sitesChina
- Study dates
- 11 Jul 2023to 24 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Fasting LDL-C of ≥ 130 mg/dL but < 190 mg/dL
- Triglycerides ≤ 400 mg/dL
- Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline
Who cannot join
- Use of any LLT within 90 days prior to screening visit
- History of ASCVD
- Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
- Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Beijing, 101200
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Changsha, Hunan, 410011
Novartis Investigative Site
Changzhou, Jiangsu, 213004
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Fuzhou, Fujian, 350025
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Novartis Investigative Site
Hangzhou, Zhejiang, 310006
Novartis Investigative Site
Hohhot, Inner Mongolia, 010017
Novartis Investigative Site
Jinan, 250012
Novartis Investigative Site
Jinzhou, Liaoning, 121001
Novartis Investigative Site
Linyi, Shandong, 276000
Novartis Investigative Site
Nanchang, Jiangxi, 330009
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shanghai, 200120
Novartis Investigative Site
Taiyuan, Shanxi, 030002
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Tianjin, 300140
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Xian, Shanxi, 710061
Novartis Investigative Site
Xuzhou, Jiangsu, 221003
Novartis Investigative Site
Zhongshan, Guangdong, 528403
About this study
Official title: A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.
Read the detailed description
This study was designed as a randomized, double-blind, multi-center Phase III trial, with a placebo-controlled treatment period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300 mg s.c. in participants aged 18 to 75 years with a low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but < 190 mg/dL who were not on any lipid lowering therapy.
The study consisted of 3 parts:
- Screening: the screening period was up to 14 days to allow adequate time for the eligibility evaluations.
- Core Part: a double-blind, placebo-controlled treatment period of 180 days in which eligible participants were randomized 1:1 to receive either inclisiran sodium 300 mg s.c. (inclisiran group) or matching placebo s.c. (control group) on Day 1 and Day 90. The end of core part (EOC) visit was conducted on Day 180. The database lock for the core part was planned to occur after all randomized participants have completed the EOC visit (or have discontinued from the study before EOC). The primary analysis was conducted after the database lock for the core part.
- Extension Part: an extended treatment period of 180 days. In the extension part, participants originally randomized to inclisiran in the core part were to continue the inclisiran treatment while participants initially randomized to placebo were to transit to the inclisiran. The extension part was to start from the Day 180 treatment dose (placebo in the inclisiran group and inclisiran for participants originally randomized to the control group).
- Being tested
- Inclisiran, Matching Placebo for Inclisiran
- Keywords
- Inclisiran, LDL-C, monotherapy, atherosclerotic cardiovascular disease, atheroma, Atherosclerosis, lipid, lipid lowering therapy (LLT), cholesterol, hypercholesteremia, mixed dyslipidemia, TC (total cholesterol), Apo B, non HDL-C, Lp(a), PCSK9, PCSK9 inhibitor, siRNA, low ASCVD risk, moderate ASCVD risk
- Medical subject headings
- Atherosclerosis, Plaque, Atherosclerotic, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Also called KJX839
Inclisiran s.c
Matching Placebo for InclisiranDrug
Also called Placebo s.c.
Matching s.c. placebo
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran - Inclisiran | Experimental | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Day 1, Day 90, and Day 270, and placebo on Day 180 Receives: Drug: Inclisiran; Drug: Matching Placebo for Inclisiran |
| Placebo- Inclisiran | Placebo comparator | Placebo on Day 1 and Day 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c on Day 180 and 270 Receives: Drug: Inclisiran; Drug: Matching Placebo for Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Measured: Baseline, Day 150
Secondary outcomes (22)
Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Measured: Baseline, Day 150
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein. The percentage change from baseline in PCSK9 at Day 150 was assessed.
Measured: Baseline, Day 150
Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein.
Measured: Baseline, Day 150
Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.
Measured: Baseline, Day 150
Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.
Measured: Baseline, Day 150
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.
Measured: Baseline, Day 150
Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.
Measured: Baseline, Day 150
Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.
Measured: Baseline, Day 150
Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.
Measured: Baseline, Day 150
Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.
Measured: Baseline, Day 150
Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.
Measured: Baseline, Day 150
Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).
Measured: Baseline, Day 150
Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).
Measured: Baseline, Day 150
Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part
Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.
Measured: Baseline, Day 150
Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part
Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.
Measured: Baseline, Day 150
Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.
Measured: Baseline, Day 150
Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.
Measured: Baseline, Day 150
Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Measured: Baseline, Day 330
Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Measured: Baseline, Day 330
Number of Participants With Adverse Events (AEs) During Core Part
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject
Measured: Core part, from treatment start (Day 1) to Day 150
Number of Participants With Adverse Events (AEs) During Extension Part
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject
Measured: Extension part, from Day 181, up to Day 360
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject
Measured: AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start11 Jul 2023
- Primary completion2 Apr 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Hypercholesterolemia or Mixed DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized, double-blind, placebo-controlled, parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888103
- Sponsor's protocol ID
- CKJX839D12305
- Acronym
- V-Mono China
- Status last verified
- Dec 2025
- First submitted
- 24 May 2023
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient level data and supporting clinical documents from eligible studies. these requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Month Randomized, Double-blind, Placebo-controlled Study Followed by a 6 Month Open- Label Extension to Assess the Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol
- ClinicalTrials.gov ID
- NCT05888103
- Acronym / sponsor ID
- V-Mono China / CKJX839D12305
- Keywords
- Inclisiran, LDL-C, monotherapy, atherosclerotic cardiovascular disease, atheroma, Atherosclerosis, lipid, lipid lowering therapy (LLT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.
Detailed description
This study was designed as a randomized, double-blind, multi-center Phase III trial, with a placebo-controlled treatment period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300 mg s.c. in participants aged 18 to 75 years with a low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but < 190 mg/dL who were not on any lipid lowering therapy.
The study consisted of 3 parts:
- Screening: the screening period was up to 14 days to allow adequate time for the eligibility evaluations.
- Core Part: a double-blind, placebo-controlled treatment period of 180 days in which eligible participants were randomized 1:1 to receive either inclisiran sodium 300 mg s.c. (inclisiran group) or matching placebo s.c. (control group) on Day 1 and Day 90. The end of core part (EOC) visit was conducted on Day 180. The database lock for the core part was planned to occur after all randomized participants have completed the EOC visit (or have discontinued from the study before EOC). The primary analysis was conducted after the database lock for the core part.
- Extension Part: an extended treatment period of 180 days. In the extension part, participants originally randomized to inclisiran in the core part were to continue the inclisiran treatment while participants initially randomized to placebo were to transit to the inclisiran. The extension part was to start from the Day 180 treatment dose (placebo in the inclisiran group and inclisiran for participants originally randomized to the control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, randomized, double-blind, placebo-controlled, parallel groups
| Arm | Type | Receives |
|---|---|---|
| Inclisiran - Inclisiran | Experimental | Drug: Inclisiran, Drug: Matching Placebo for InclisiranInclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Day 1, Day 90, and Day 270, and placebo on Day 180 |
| Placebo- Inclisiran | Placebo comparator | Drug: Inclisiran, Drug: Matching Placebo for InclisiranPlacebo on Day 1 and Day 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c on Day 180 and 270 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained before any assessment is performed.
- Fasting LDL-C of ≥ 130 mg/dL but < 190 mg/dL
- Triglycerides ≤ 400 mg/dL
- Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline
Key exclusion criteria (5 listed)
- Use of any LLT within 90 days prior to screening visit
- History of ASCVD
- Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
- Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| InclisiranAlso: KJX839Inclisiran s.c | Drug | Inclisiran - Inclisiran, Placebo- Inclisiran |
| Matching Placebo for InclisiranAlso: Placebo s.c.Matching s.c. placebo | Drug | Inclisiran - Inclisiran, Placebo- Inclisiran |
Primary outcome
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
22 secondary outcomes
Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
Time frame: Baseline, Day 150
Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part
Time frame: Baseline, Day 330
Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part
Time frame: Baseline, Day 330
Number of Participants With Adverse Events (AEs) During Core Part
Time frame: Core part, from treatment start (Day 1) to Day 150
Number of Participants With Adverse Events (AEs) During Extension Part
Time frame: Extension part, from Day 181, up to Day 360
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
Time frame: AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient level data and supporting clinical documents from eligible studies. these requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclisiran in people with Primary Hypercholesterolemia or Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 28 sites in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part (time frame: Baseline, Day 150). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.