HypercholesterolemiaPhase 2ORION-15NCT04666298
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
A Phase 2 study testing Inclisiran sodium in people with Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, run by Novartis Pharmaceuticals at 42 sites in Japan.
Trial summary
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
- What is being tested?
- Inclisiran sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 42 sitesJapan
- Study dates
- 29 Jan 2021to 19 Oct 2022
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH)
- As per the JAS 2017 guideline, participants not meeting the LDL-C management targets.
- Participants on statins should be receiving a maximally tolerated dose.
- Participants not receiving statins must have documented evidence of intolerance to at least one statin.
- The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180
Who cannot join
- Participants diagnosed with homozygous familial hypercholesterolemia (HoFH).
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
- New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction <25%.
- Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.
- Uncontrolled hypertension: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg prior to randomization despite antihypertensive therapy.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin >2x ULN at screening.
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Japan42 sites
Novartis Investigative Site
Chiyoda City, Tokyo
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0027
Novartis Investigative Site
Chuo-ku, Tokyo, 103-0028
Novartis Investigative Site
Chuoh-ku, 104-0031
Novartis Investigative Site
Fujisawa, Kanagawa, 251-0041
Novartis Investigative Site
Gifu, 500-8384
Novartis Investigative Site
Iruma-gun, Saitama, 350-0495
Novartis Investigative Site
Itoshima, Fukuoka, 819-1104
Novartis Investigative Site
Izumisano, Osaka, 598-8577
Novartis Investigative Site
Kahoku-gun, Ishikawa-ken, 920-0293
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8650
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920-8641
Novartis Investigative Site
Kawasaki, Kanagawa, 216-8511
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0057
Novartis Investigative Site
Kitakyushu, Fukuoka, 804-0025
Novartis Investigative Site
Kitakyushu, Fukuoka, 805-8508
Novartis Investigative Site
Kitakyushu, Fukuoka, 806-8501
Novartis Investigative Site
Komatsu, Ishikawa-ken, 923-0961
Novartis Investigative Site
Kuse, Kyoto, 613-0034
Novartis Investigative Site
Kyoto, 612-8555
Novartis Investigative Site
Matsubara, Osaka, 580-0032
Novartis Investigative Site
Matsudo, Chiba, 271 0077
Novartis Investigative Site
Nagoya, Aichi-ken
Novartis Investigative Site
Nakagawa, Fukuoka, 811-1244
Novartis Investigative Site
Nerima-ku, Tokyo, 176-8530
Novartis Investigative Site
Ōita, 870-8511
Novartis Investigative Site
Ōmura, Nagasaki, 856-8562
Novartis Investigative Site
Osaka, Osaka, 530 0001
Novartis Investigative Site
Osaka, Osaka, 540-0006
Novartis Investigative Site
Osaka, Osaka, 543-0035
Novartis Investigative Site
Saga, 840-8571
Novartis Investigative Site
Sapporo, Hokkaido, 006-8555
Novartis Investigative Site
Sapporo, Hokkaido, 062-8618
Novartis Investigative Site
Sashima-gun, Ibaraki, 306-0433
Novartis Investigative Site
Sayama, Saitama, 350-1305
Novartis Investigative Site
Sendai, Miyagi, 983-0039
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-8666
Novartis Investigative Site
Shinjuku Ku, Tokyo, 160-0008
Novartis Investigative Site
Suita, Osaka, 564-8565
Novartis Investigative Site
Suita, Osaka, 565-0853
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760 8557
Novartis Investigative Site
Tsuchiura, Ibaraki, 300-0028
About this study
Official title: A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).
Read the detailed description
The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on Day 90 and Day 270, and the follow-up period to Day 360.
The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit.
After the primary analysis, double-blind treatment period were maintained to Day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in Japan.
- Being tested
- Inclisiran sodium, Placebo
- Keywords
- inclisiran, siRNA, dyslipidemia, PCSK9, Hypercholesterolemia, LDL-C
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclisiran sodiumDrug
Also called KJX839
Subcutaneously injected on Day 1, 90 and 270.
PlaceboDrug
Also called KJX839 placebo
Subcutaneously injected on Day 1, 90, and 270.
| Study group | Role | What they receive |
|---|---|---|
| 300 mg inclisiran sodium | Experimental | Subcutaneous injection Receives: Drug: Inclisiran sodium |
| 200 mg inclisiran sodium | Experimental | Subcutaneous injection Receives: Drug: Inclisiran sodium |
| 100 mg inclisiran sodium | Experimental | Subcutaneous injection Receives: Drug: Inclisiran sodium |
| Placebo | Placebo comparator | Subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180
Percent change from baseline in LDL-C was calculated to evaluate the effect of inclisiran at Day 180.
Difference between different inclisiran dose groups and the placebo group in percentage change in LDL-C levels from baseline to Day 180 were calculated to capture both, the effect of the study drug and the effect of additional medications, mirroring the conditions in clinical practice.
An MMRM (Mixed-effect Model with Repeated Measurement) was used as the primary analysis model, with treatment group, visits, interaction between visits and treatment groups, current use of statins or other lipid-modifying therapies as fixed effects, and baseline LDL-C as a continuous covariate.
Measured: Baseline, Day 180
Secondary outcomes (15)
Percent Change From Baseline in PCSK9 by Visit
Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time.
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in LDL-C by Visit
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time.
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150
Absolute Change in LDL-C From Baseline at Day 180
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180.
Measured: Baseline, Day 180
Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180
Proportion of participants with LDL-C greater than 80% of baseline value at Day 180 was calculated to evaluate the effect of inclisiran until Day 180.
Subjects are counted if the LDL-C value is greater than '0.8*(LDL-C at Baseline - LDL-C at Day180) + LDL-C at Day180', or the LDL-C value is greater than or equal to the LDL-C at Baseline.
Measured: Baseline, Day 180
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Proportion of participants with greater or equal to 50% LDL-C reduction from baseline was calculated to evaluate the effect of inclisiran over time.
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Cholesterol by Visit
Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Triglycerides by Visit
Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in HDL Cholesterol by Visit
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in VLDL-C by Visit
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL - C) by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Apo- A1 by Visit
Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Apo- B by Visit
Percent change from baseline in Apolipoprotein B (Apo-B) by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Lipoprotein-a by Visit
Percent change from baseline in Lipoprotein a (LP(a)) by visit was calculated to evaluate the effect of inclisiran over time
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180
Proportion of participants who attain lipid control target pre-specified by Japan Atherosclerosis Society(JAS) 2017 guidelines for their level of cardiovascular risk at Day 180 was calculated to evaluate the effect of inclisiran.
Measured: Day 180
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Number of participants by LDL-C levels was calculated to evaluate the effect of inclisiran.
Measured: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start29 Jan 2021
- Primary completion18 Apr 2022
- Study completion19 Oct 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 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
- NCT04666298
- Sponsor's protocol ID
- CKJX839A11201
- Acronym
- ORION-15
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2020
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- 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
Publications
Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.
PubMed 33990512
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Effect of Different Doses of Inclisiran Given as Subcutaneous Injections in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
- ClinicalTrials.gov ID
- NCT04666298
- Acronym / sponsor ID
- ORION-15 / CKJX839A11201
- Keywords
- inclisiran, siRNA, dyslipidemia, PCSK9, Hypercholesterolemia, LDL-C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).
Detailed description
The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on Day 90 and Day 270, and the follow-up period to Day 360.
The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit.
After the primary analysis, double-blind treatment period were maintained to Day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 300 mg inclisiran sodium | Experimental | Drug: Inclisiran sodiumSubcutaneous injection |
| 200 mg inclisiran sodium | Experimental | Drug: Inclisiran sodiumSubcutaneous injection |
| 100 mg inclisiran sodium | Experimental | Drug: Inclisiran sodiumSubcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH)
- As per the JAS 2017 guideline, participants not meeting the LDL-C management targets.
- Participants on statins should be receiving a maximally tolerated dose.
- Participants not receiving statins must have documented evidence of intolerance to at least one statin.
- The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180
Key exclusion criteria (7 listed)
- Participants diagnosed with homozygous familial hypercholesterolemia (HoFH).
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
- New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction <25%.
- Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.
- Uncontrolled hypertension: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg prior to randomization despite antihypertensive therapy.
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 sodiumAlso: KJX839Subcutaneously injected on Day 1, 90 and 270. | Drug | 100 mg inclisiran sodium, 200 mg inclisiran sodium, 300 mg inclisiran sodium |
| PlaceboAlso: KJX839 placeboSubcutaneously injected on Day 1, 90, and 270. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180
Time frame: Baseline, Day 180
Percent change from baseline in LDL-C was calculated to evaluate the effect of inclisiran at Day 180. Difference between different inclisiran dose groups and the placebo group in percentage change in LDL-C levels from baseline to Day 180 were calculated to capture both, the effect of the study drug and the effect of additional medications, mirroring the conditions in clinical practice. An MMRM (Mixed-effect Model with Repeated Measurement) was used as the primary analysis model, with treatment group, visits, interaction between visits and treatment groups, current use of statins or other lipid-modifying therapies as fixed effects, and baseline LDL-C as a continuous covariate.
15 secondary outcomes
Percent Change From Baseline in PCSK9 by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in LDL-C by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150
Absolute Change in LDL-C From Baseline at Day 180
Time frame: Baseline, Day 180
Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180
Time frame: Baseline, Day 180
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Cholesterol by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Triglycerides by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in HDL Cholesterol by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in VLDL-C by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Apo- A1 by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Apo- B by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Percent Change From Baseline in Lipoprotein-a by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180
Time frame: Day 180
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33990512Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.
- Patient Lay Trial SummaryLink 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
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inclisiran sodium in people with Hypercholesterolemia and Heterozygous Familial Hypercholesterolemia, run by Novartis Pharmaceuticals at 42 sites in Japan.
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 5 inclusion and 7 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 May 2023). 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?
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 (time frame: Baseline, Day 180). 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 NCT04666298, which also lists 1 linked publication.
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 20 Jun 2024.