ASCVDPhase 3ORION-11NCT03400800
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
A Phase 3 study testing Inclisiran Sodium in people with ASCVD and Risk Factor, Cardiovascular, run by The Medicines Company at 70 sites in 7 countries.
Trial summary
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- 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
- 1,617 participants
- Where
- 70 sitesin 7 countries
- Study dates
- 1 Nov 2017to 27 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants may be included if they meet all of the following inclusion criteria prior to randomization:
- Male or female participants ≥18 years of age.
- History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
- Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
- Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
- Calculated glomerular filtration rate >30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology
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- Participants on statins should be receiving a maximally tolerated dose.
- Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
- Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.
- Subjects were willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
Who cannot join
- Participants will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- New York Heart Association (NYHA) class IV heart failure.
- Uncontrolled cardiac arrhythmia.
- Uncontrolled severe hypertension.
- Active liver disease.
- Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
Show all 13Show fewer
- Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
- Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
- Women who are surgically sterilized at least 3 months prior to enrollment.
- Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
- Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
70 sites in 7 countries.
70 sites in 7 countries
United Kingdom23 sites
Research Site - 11044-028
Bollington, SK10 5JH
Research Site - 11044-026
Bury, BL9 ONJ
Research Site - 11044-007
Cardiff, CF15 9SS
Research Site - 11044-024
Cheadle Hulme, SK8 5LL
Research Site - 11044-014
Chorley, Lancashire, PR7 7NA
Research Site - 11044-027
Davyhulme, Manchester, M41 7WJ
Research Site - 11044-010
Derby, S40 4AA
Research Site - 11044-006
Edgbaston, Birmingham, B15 2SQ
Research Site - 11044-009
Exeter, Devon, EX2 5DW
Research Site - 11044-001
Glasgow, G20 0SP
Research Site - 11044-008
Hexham, NE46 1QJ
Research Site - 11044-012
Liskeard, Cornwall, PL14 3XA
Research Site - 11044-020
Macclesfield, SK11 6JL
Research Site - 11044-025
Manchester, M14 6WP
Research Site - 11044-005
Manchester, M15 6SX
Research Site - 11044-029
Manchester, M20 2RN
Research Site - 11044-019
Plymouth, Devon, PL5 3JB
Research Site - 11044-003
Reading, RG2 0TG
Research Site - 11044-022
Sale, Cheshire, M33 2RH
Research Site - 11044-023
Sale, Cheshire, M33 4BR
Research Site - 11044-002
Stockton, TS19 8PE
Research Site - 11044-021
Timperley, Cheshire, WA14 5PF
Research Site - 11044-004
Waterloo, Liverpool, L22 0LG
Poland19 sites
Research Site 11048-016
Brzozów, Podkarpackie Voivodeship, 36-200
Research Site 11048-018
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079
Research Site 11048-011
Bydgoszcz, 85-231
Research Site 11048-004
Gdansk, 80-382
Research Site 11048-017
Gdansk, 80-542
Research Site 11048-005
Gdynia, 81-537
Research Site 11048-007
Katowice, 04-040
Research Site 11048-012
Katowice, 40-648
Research Site 11048-014
Krakow, 31-216
Research Site 11048-003
Krakow, 31-501
Research Site 11048-008
Lublin, 20-709
Research Site 11048-001
Poznan, 60-702
Research Site 11048-019
Ruda Śląska, Silesian Voivodeship, 41-709
Research Site 11048-013
Rzeszów, 35-055
Research Site 11048-015
Tarnów, 33-100
Research Site 11048-009
Warsaw, 04-628
Research Site 11048-006
Warszawice, 01-192
Research Site 11048-002
Wroclaw, 50-381
Research Site 11048-010
Wroclaw, 51-314
Ukraine9 sites
Research Site - 11380-005
Cherkasy, 18009
Research Site - 11380-008
Kharkiv, 61444
Research Site - 11380-004
Kiev, 3115
Research Site - 11380-009
Kiev, 3115
Research Site - 11380-001
Kyiv, 2002
Research Site - 11380-002
Kyiv, 3037
Research Site - 11380-003
Kyiv, 3049
Research Site - 11380-007
Lviv, 79060
Research Site - 11380-006
Uzhhorod, 8800
South Africa8 sites
Research Site 11027-003
Bloemfontein, Free State, 9301
Research Site 11027-001
Cape Town, Western Cape, 7500
Research Site 11027-013
Cape Town, Western Cape, 7646
Research Site 11027-005
Johannesburg, Gauteng, 1619
Research Site 11027-007
Kuils River, Western Cape, 7130
Research Site 11027-006
Pretoria, 184
Research Site 11027-004
Somerset West, Western Cape, 7130
Research Site 11027-011
Welkom, 9459
Germany5 sites
Research Site 11049-006
Berlin, 12567
Research Site 11049-002
Bochum, 44787
Research Site 11049-003
Frankfurt, 60313
Research Site 11049-007
Heidelberg, 69120
Research Site 11049-001
Leipzig, 4103
Hungary4 sites
Research Site 11036-001
Budapest, 1036
Research Site 11036-004
Debrecen, 4025
Research Site 11036-002
Hatvan, 3000
Research Site 11036-003
Zalaegerszeg, 8900
Czechia2 sites
Research Site 11420-002
Chomutov, 43001
Research Site 11420-003
Uherské Hradiště, 68601
About this study
Official title: A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Being tested
- Inclisiran Sodium, Placebo
- Keywords
- Inclisiran sodium, ASCVD, LDL-C
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclisiran SodiumDrug
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
PlaceboDrug
Also called Saline Solution
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran | Experimental | Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months. Receives: Drug: Inclisiran Sodium |
| Saline Solution | Placebo comparator | Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in LDL-C From Baseline to Day 510
Measured: Baseline, Day 510
Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
Measured: Baseline, Day 90 to Day 540
Secondary outcomes (6)
Absolute Change In LDL-C From Baseline To Day 510
Measured: Baseline, Day 510
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Measured: Baseline, Day 90 to Day 540
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Measured: Baseline, Day 510
Percentage Change in Total Cholesterol From Baseline to Day 510
Measured: Baseline, Day 510
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
Measured: Baseline, Day 510
Percentage Change in Non-HDL-C From Baseline to Day 510
Measured: Baseline, Day 510
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Nov 2017
- Primary completion31 Jul 2019
- Study completion27 Aug 2019
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 (6)Papers the sponsor has linked to this study.
- Other trials for ASCVDStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,617 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ray Kausik, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400800
- Sponsor's protocol ID
- MDCO-PCS-17-08
- Acronym
- ORION-11
- Status last verified
- Aug 2020
- First submitted
- 9 Jan 2018
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Landmesser U, Ray KK, Raal FJ, Garcia Conde L, Han J, Koenig W, Leiter LA, Schwartz GG, Wright RS; on behalf of the ORION Investigators. Inclisiran in Patients with CKD: Post Hoc Pooled Analysis of Three Phase 3 Trials. J Am Soc Nephrol. 2026 Jul 1;37(7):1497-1506. doi: 10.1681/ASN.0000001006. Epub 2026 Jan 28.
PubMed 41604274Wright RS, Ray KK, Landmesser U, Koenig W, Raal FJ, Leiter LA, Conde LG, Han J, Schwartz GG. Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials. Mayo Clin Proc. 2024 Jul 5:S0025-6196(24)00167-8. doi: 10.1016/j.mayocp.2024.03.025. Online ahead of print.
PubMed 39093262Leiter LA, Raal FJ, Schwartz GG, Koenig W, Ray KK, Landmesser U, Han J, Conde LG, Wright RS. Inclisiran in individuals with diabetes or obesity: Post hoc pooled analyses of the ORION-9, ORION-10 and ORION-11 Phase 3 randomized trials. Diabetes Obes Metab. 2024 Aug;26(8):3223-3237. doi: 10.1111/dom.15650. Epub 2024 May 17.
PubMed 38757725Dutta S, Shah R, Singhal S, Singh S, Piparva K, Katoch CDS. A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients. Expert Opin Drug Saf. 2024 Feb;23(2):187-198. doi: 10.1080/14740338.2023.2293201. Epub 2023 Dec 19.
PubMed 38063346Ray KK, Wright RS. Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol. Future Cardiol. 2023 Mar;19(4):175-184. doi: 10.2217/fca-2022-0133. Epub 2023 Jun 6.
PubMed 37282500Ray 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 32187462
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. 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 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
- ClinicalTrials.gov ID
- NCT03400800
- Acronym / sponsor ID
- ORION-11 / MDCO-PCS-17-08
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Keywords
- Inclisiran sodium, ASCVD, LDL-C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,617 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclisiran | Experimental | Drug: Inclisiran SodiumInclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months. |
| Saline Solution | Placebo comparator | Drug: PlaceboPlacebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants may be included if they meet all of the following inclusion criteria prior to randomization:
- Male or female participants ≥18 years of age.
- History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).
- Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
- Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
Key exclusion criteria (13 listed)
- Participants will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- New York Heart Association (NYHA) class IV heart failure.
- Uncontrolled cardiac arrhythmia.
- Uncontrolled severe hypertension.
- Active liver disease.
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 SodiumInclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis. | Drug | Inclisiran |
| PlaceboAlso: Saline SolutionPlacebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection). | Drug | Saline Solution |
Primary outcome
Percentage Change in LDL-C From Baseline to Day 510
Time frame: Baseline, Day 510
Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
Time frame: Baseline, Day 90 to Day 540
6 secondary outcomes
Absolute Change In LDL-C From Baseline To Day 510
Time frame: Baseline, Day 510
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Time frame: Baseline, Day 90 to Day 540
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Total Cholesterol From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
Time frame: Baseline, Day 510
Percentage Change in Non-HDL-C From Baseline to Day 510
Time frame: Baseline, Day 510
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41604274Landmesser U, Ray KK, Raal FJ, Garcia Conde L, Han J, Koenig W, Leiter LA, Schwartz GG, Wright RS; on behalf of the ORION Investigators. Inclisiran in Patients with CKD: Post Hoc Pooled Analysis of Three Phase 3 Trials. J Am Soc Nephrol. 2026 Jul 1;37(7):1497-1506. doi: 10.1681/ASN.0000001006. Epub 2026 Jan 28.
- Derived from this study: PubMed 39093262Wright RS, Ray KK, Landmesser U, Koenig W, Raal FJ, Leiter LA, Conde LG, Han J, Schwartz GG. Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials. Mayo Clin Proc. 2024 Jul 5:S0025-6196(24)00167-8. doi: 10.1016/j.mayocp.2024.03.025. Online ahead of print.
- Derived from this study: PubMed 38757725Leiter LA, Raal FJ, Schwartz GG, Koenig W, Ray KK, Landmesser U, Han J, Conde LG, Wright RS. Inclisiran in individuals with diabetes or obesity: Post hoc pooled analyses of the ORION-9, ORION-10 and ORION-11 Phase 3 randomized trials. Diabetes Obes Metab. 2024 Aug;26(8):3223-3237. doi: 10.1111/dom.15650. Epub 2024 May 17.
- Derived from this study: PubMed 38063346Dutta S, Shah R, Singhal S, Singh S, Piparva K, Katoch CDS. A systematic review and meta-analysis of tolerability, cardiac safety and efficacy of inclisiran for the therapy of hyperlipidemic patients. Expert Opin Drug Saf. 2024 Feb;23(2):187-198. doi: 10.1080/14740338.2023.2293201. Epub 2023 Dec 19.
- Derived from this study: PubMed 37282500Ray KK, Wright RS. Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol. Future Cardiol. 2023 Mar;19(4):175-184. doi: 10.2217/fca-2022-0133. Epub 2023 Jun 6.
- Derived from this study: 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.
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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.
Ray Kausik, MD principal investigator
Imperial College London
70 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclisiran Sodium in people with ASCVD and Risk Factor, Cardiovascular, run by The Medicines Company at 70 sites in 7 countries.
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 10 inclusion and 13 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United Kingdom, Poland, Ukraine, South Africa, Germany and 2 more countries. 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 21 Aug 2020). 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 LDL-C From Baseline to Day 510 (time frame: Baseline, Day 510). The study lists 2 primary outcomes in all. 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 NCT03400800, which also lists 6 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 21 Aug 2020.