HypertriglyceridemiaPhase 2NCT03385239
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
A Phase 2 study testing ISIS 678354 in people with Hypertriglyceridemia and Cardiovascular Diseases, run by Akcea Therapeutics at 31 sites in 2 countries.
Trial summary
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in participants with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertriglyceridemia, Cardiovascular Diseases
- What is being tested?
- ISIS 678354
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 30 Jan 2018to 25 Feb 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease).
- Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤) 500 mg/dL (≥ 5.7 mmol/L) at Screening.
- Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.
- Must be on standard-of-care preventative therapy for known CVD risk factors.
Who cannot join
- Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/transient ischemic attack (TIA).
- Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis.
- Heart failure New York Heart Association (NYHA) class IV.
- Type 1 diabetes mellitus.
- Type 2 diabetes mellitus with any of the following:
- Newly diagnosed within 12 weeks of Screening.
Show all 9Show fewer
- Glycated hemoglobin (HbA1c) ≥ 9.0% at Screening.
- Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of new medication within 12 weeks of Screening [with the exception of ± 10 units of insulin].
- Body Mass Index (BMI) greater than (>) 40 kilograms per square meter (kg/m^2).
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States24 sites
Clinical Site
Ames, Iowa, 50010
Clinical Site
Boca Raton, Florida, 33434
Clinical Site
Carmichael, California, 95608
Clinical Site
Cooperstown, New York, 13326
Clinical Site
Cottonwood, Arizona, 86326
Clinical Site
Fall River, Massachusetts, 02721
Clinical Site
Fresno, California, 93720
Clinical Site
Greer, South Carolina, 29651
Clinical Site
High Point, North Carolina, 27262
Clinical Site
Houston, Texas, 77030
Clinical Site
Jacksonville, Florida, 32216
Clinical Site
Kansas City, Kansas, 66160
Clinical Site
La Jolla, California, 92037-7410
Clinical Site
Lansdale, Pennsylvania, 19446
Clinical Site
Little Rock, Arkansas, 72205
Clinical Site
Long Beach, California, 90807
Clinical Site
Louisville, Kentucky, 40213
Clinical Site
Milwaukee, Wisconsin, 53215
Clinical Site
Montclair, California, 91763
Clinical Site
Munster, Indiana, 46321
Clinical Site
New Port Richey, Florida, 34652
Clinical Site
Portland, Oregon, 97239
Clinical Site
Providence, Rhode Island, 02906
Clinical Site
Wilmington, Delaware, 19803
Canada7 sites
Clinical Site
Brossard, Quebec, J4Z 2K9
Clinical Site
Cambridge, Ontario, N1R 6V6
Clinical Site
Chicoutimi, Quebec
Clinical Site
Gatineau, Quebec, J8Y 6S8
Clinical Site
Greater Sudbury, Ontario, P3E 5M4
Clinical Site
Montreal, Quebec, H1T 1C8
Clinical Site
Québec, Quebec, G1V 4W2
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) or at a High Risk for CVD
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in participants with hypertriglyceridemia and established CVD or at a high risk for CVD.
- Conditions
- Hypertriglyceridemia, Cardiovascular Diseases
- Being tested
- ISIS 678354, Placebo
- Keywords
- AKCEA-APOCIII-LRx, IONIS-APOCIII-LRx, Dyslipidemia, Metabolic Disease, Hyperlipidemia, Cardiac Disease, Lipid Metabolism Disorders, Triglycerides High, Vascular Diseases
- Medical subject headings
- Hypertriglyceridemia, Cardiovascular Diseases, Dyslipidemias, Metabolic Diseases, Hyperlipidemias, Heart Diseases, Lipid Metabolism Disorders, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS 678354Drug
Also called AKCEA-APOCIII-LRx, IONIS-APOCIII-LRx
ISIS 678354 solution for SC injection.
PlaceboDrug
Sterile Normal Saline (0.9% NaCl).
| Study group | Role | What they receive |
|---|---|---|
| Pooled Placebo | Placebo comparator | Participants in each cohort (A, B, C and D) were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354). Receives: Drug: Placebo |
| Cohort A: ISIS 678354: 10 mg Q4W | Experimental | Cohort A participants received 10 milligrams (mg) ISIS 678354, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses. Receives: Drug: ISIS 678354 |
| Cohort C: ISIS 678354: 15 mg Q2W | Experimental | Cohort C participants received 15 mg ISIS 678354, SC injection, once every 2 weeks (Q2W) for up to 51 weeks and a maximum of 26 doses. Receives: Drug: ISIS 678354 |
| Cohort D: ISIS 678354: 10 mg QW | Experimental | Cohort D participants received 10 mg ISIS 678354, SC injection, once weekly (QW) for up to 52 weeks and a maximum of 52 doses. Receives: Drug: ISIS 678354 |
| Cohort B: ISIS 678354: 50 mg Q4W | Placebo comparator | Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses. Receives: Drug: ISIS 678354 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Fasting Triglycerides (TG) at the Primary Analysis Time Point
An analysis of covariance (ANCOVA) model was performed on the log ratio of TG value at the Primary Analysis Time Point to TG value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: (ratio of TG value at the Primary Analysis Time Point to TG value at Baseline - 1) × 100.
Measured: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. A TEAE was defined as any AE starting on or after the first dose of the study drug.
Measured: Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Secondary outcomes (6)
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point value to Baseline value for ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I. The estimate of the log ratio was converted back to the original scale and percent change for each lipid parameter was calculated using formula: (ratio of Primary Analysis Time Point value to Baseline value - 1) × 100.
Measured: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Percentage of Participants Who Achieved Fasting Triglycerides (TG) <= 150 mg/dL (<= 1.7 Millimoles Per Liter [mmol/L])
The percentage of participants who achieved <= 150 mg/dL or <= 1.7 mmol/L of fasting TG levels at the primary analysis time point were compared between each ISIS 678354 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline TG value as a covariate.
Measured: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Percentage of Participants Who Achieved Fasting Triglycerides (TG) <= 100 mg/dL (<= 1.13 mmol/L)
The percentage of participants who achieved <= 100 mg/dL or <= 1.13 mmol/L of fasting TG levels at the primary analysis time point were compared between each ISIS 678354 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline TG value as a covariate.
Measured: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Maximum Plasma Concentration (Cmax) of ISIS 678354
Measured: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
Time to Reach Maximum Plasma Concentration (Tmax) of ISIS 678354
Measured: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of ISIS 678354
Measured: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start30 Jan 2018
- Primary completion25 Nov 2019
- Study completion25 Feb 2020
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 (2)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akcea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ionis Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385239
- Sponsor's protocol ID
- ISIS 678354-CS2
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2017
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin L, Brush MN, Nelson CB, Alexander VJ, Xia S, Gordts PLSM, Tsimikas S. A Novel Triglyceride- and Cholesterol-Enriched Lipoprotein(a) Phenotype in Moderate Hypertriglyceridemia: Reversal by ApoC-III Inhibition. JACC Basic Transl Sci. 2026 Sep 17;11(10):101699. doi: 10.1016/j.jacbts.2026.101699. Online ahead of print.
PubMed 42753678Tardif JC, Karwatowska-Prokopczuk E, Amour ES, Ballantyne CM, Shapiro MD, Moriarty PM, Baum SJ, Hurh E, Bartlett VJ, Kingsbury J, Figueroa AL, Alexander VJ, Tami J, Witztum JL, Geary RS, O'Dea LSL, Tsimikas S, Gaudet D. Apolipoprotein C-III reduction in subjects with moderate hypertriglyceridaemia and at high cardiovascular risk. Eur Heart J. 2022 Apr 6;43(14):1401-1412. doi: 10.1093/eurheartj/ehab820.
PubMed 35025993
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) or at a High Risk for CVD
- ClinicalTrials.gov ID
- NCT03385239
- Acronym / sponsor ID
- ISIS 678354-CS2
- Conditions
- Hypertriglyceridemia, Cardiovascular Diseases
- Keywords
- AKCEA-APOCIII-LRx, IONIS-APOCIII-LRx, Dyslipidemia, Metabolic Disease, Hyperlipidemia, Cardiac Disease, Lipid Metabolism Disorders, Triglycerides High
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Akcea TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Ionis Pharmaceuticals, Inc.
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Posted 11 Jan 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 multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in participants with hypertriglyceridemia and established CVD or at a high risk for CVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pooled Placebo | Placebo comparator | Drug: PlaceboParticipants in each cohort (A, B, C and D) were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354). |
| Cohort A: ISIS 678354: 10 mg Q4W | Experimental | Drug: ISIS 678354Cohort A participants received 10 milligrams (mg) ISIS 678354, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses. |
| Cohort C: ISIS 678354: 15 mg Q2W | Experimental | Drug: ISIS 678354Cohort C participants received 15 mg ISIS 678354, SC injection, once every 2 weeks (Q2W) for up to 51 weeks and a maximum of 26 doses. |
| Cohort D: ISIS 678354: 10 mg QW | Experimental | Drug: ISIS 678354Cohort D participants received 10 mg ISIS 678354, SC injection, once weekly (QW) for up to 52 weeks and a maximum of 52 doses. |
| Cohort B: ISIS 678354: 50 mg Q4W | Placebo comparator | Drug: ISIS 678354Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease).
- Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤) 500 mg/dL (≥ 5.7 mmol/L) at Screening.
- Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.
- Must be on standard-of-care preventative therapy for known CVD risk factors.
Key exclusion criteria (9 listed)
- Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/transient ischemic attack (TIA).
- Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis.
- Heart failure New York Heart Association (NYHA) class IV.
- Type 1 diabetes mellitus.
- Type 2 diabetes mellitus with any of the following:
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 |
|---|---|---|
| ISIS 678354Also: AKCEA-APOCIII-LRx, IONIS-APOCIII-LRxISIS 678354 solution for SC injection. | Drug | Cohort A: ISIS 678354: 10 mg Q4W, Cohort B: ISIS 678354: 50 mg Q4W, Cohort C: ISIS 678354: 15 mg Q2W, Cohort D: ISIS 678354: 10 mg QW |
| PlaceboSterile Normal Saline (0.9% NaCl). | Drug | Pooled Placebo |
Primary outcome
Percent Change From Baseline in Fasting Triglycerides (TG) at the Primary Analysis Time Point
Time frame: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
An analysis of covariance (ANCOVA) model was performed on the log ratio of TG value at the Primary Analysis Time Point to TG value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: (ratio of TG value at the Primary Analysis Time Point to TG value at Baseline - 1) × 100.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. A TEAE was defined as any AE starting on or after the first dose of the study drug.
6 secondary outcomes
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
Time frame: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Percentage of Participants Who Achieved Fasting Triglycerides (TG) <= 150 mg/dL (<= 1.7 Millimoles Per Liter [mmol/L])
Time frame: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Percentage of Participants Who Achieved Fasting Triglycerides (TG) <= 100 mg/dL (<= 1.13 mmol/L)
Time frame: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Maximum Plasma Concentration (Cmax) of ISIS 678354
Time frame: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
Time to Reach Maximum Plasma Concentration (Tmax) of ISIS 678354
Time frame: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of ISIS 678354
Time frame: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42753678Lin L, Brush MN, Nelson CB, Alexander VJ, Xia S, Gordts PLSM, Tsimikas S. A Novel Triglyceride- and Cholesterol-Enriched Lipoprotein(a) Phenotype in Moderate Hypertriglyceridemia: Reversal by ApoC-III Inhibition. JACC Basic Transl Sci. 2026 Sep 17;11(10):101699. doi: 10.1016/j.jacbts.2026.101699. Online ahead of print.
- Derived from this study: PubMed 35025993Tardif JC, Karwatowska-Prokopczuk E, Amour ES, Ballantyne CM, Shapiro MD, Moriarty PM, Baum SJ, Hurh E, Bartlett VJ, Kingsbury J, Figueroa AL, Alexander VJ, Tami J, Witztum JL, Geary RS, O'Dea LSL, Tsimikas S, Gaudet D. Apolipoprotein C-III reduction in subjects with moderate hypertriglyceridaemia and at high cardiovascular risk. Eur Heart J. 2022 Apr 6;43(14):1401-1412. doi: 10.1093/eurheartj/ehab820.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS 678354 in people with Hypertriglyceridemia and Cardiovascular Diseases, run by Akcea Therapeutics at 31 sites in 2 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 4 inclusion and 9 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. 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 11 Jan 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 Fasting Triglycerides (TG) at the Primary Analysis Time Point (time frame: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)). 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 NCT03385239, which also lists 2 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 11 Jan 2023.