Statin Adverse ReactionNCT07511686
Metabolic and Mitochondrial Changes in Statin-Induced Myopathy
An observational study of Statin Adverse Reaction and Statin-induced Myopathy, run by Riga Stradins University at 1 site in Latvia.
Trial summary
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Statin Adverse Reaction, Statin-induced Myopathy
- What is being tested?
- Blood sampling and laboratory assessment and Muscle biopsy
- How many people
- 38 participants
- Where
- 1 siteLatvia
- Study dates
- 22 Aug 2023to 9 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult participants (≥18 years) of Caucasian ethnicity recruited at the Latvian Cardiology Center of Pauls Stradiņš Clinical University Hospital. The study includes three groups: (1) patients with elevated creatine kinase levels with or without muscle symptoms suggestive of statin-associated muscle myopathy, (2) patients receiving stable high-dose statin therapy without muscle symptoms, and (3) individuals not receiving lipid-lowering therapy and without unexplained muscle symptoms. Participants may be hospitalized patients or outpatients, including referrals from other medical institutions. All participants must provide written informed consent, and a subset of participants may additionally consent to undergo muscle biopsy for further analysis of mitochondrial metabolism in muscle tissue.
Who may be able to join
- Age at least 18 years.
- A representative of the Caucasian race.
- The patient agrees to participate in the study by signing an informed consent form for participation in the study. (The patient may only be included in the muscle biopsy sub-study if the relevant additional informed consent form has also been signed.)
- Specific inclusion criteria for each of the study subgroups:
- Group A: patients have elevated creatine kinase levels >1.5x above the upper limit of normal (women >325 U/L and men >504 U/L) with or without muscle symptoms that have no other obvious explanation (including intense physical activity in the last 7 days).
- Group B: atorvastatin 40-80 mg or rosuvastatin 20-40 mg monotherapy for at least 8 weeks at a constant dose and no muscle symptoms (pain, weakness, fatigue, cramps) during this period, CK <200 U/L.
- Group C: no lipid-lowering agents have been used during the last year and there have been no muscle symptoms (pain, weakness, fatigue, cramps) of unknown origin lasting >1 week during this period, CK <200 U/L.
Who cannot join
- Any disease that, in the opinion of the investigator, could also cause a significant increase in CK or muscle symptoms.
- Use of other cholesterol-lowering agents specific to each of the study groups:
- Group A: use of red yeast rice extract, fibrates, or bempedoic acid within the last 8 weeks.
- Group B: use of other non-statin cholesterol-lowering agents (red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 8 weeks.
- Group C: use of any cholesterol-lowering agents (statins, red yeast rice extract, ezetimibe, fibrates, PCSK9 inhibitors, inclisiran, bempedoic acid) in the last 12 weeks.
- Intense physical activity in the last 7 days.
Show all 12Show fewer
- Acute myocardial infarction or stroke in the last 4 weeks.
- Major surgery within the last 4 weeks (invasive cardiac procedures are not an exclusion criterion).
- Patients with severe illness that, in the investigator's opinion, may significantly affect the patient's overall metabolism (e.g., active malignancy, terminal heart failure, etc.).
- Excessive alcohol consumption (binge drinking or >7 units of alcohol per day) within the last year.
- Use of other substances or medications known to have direct myotoxic effects (e.g., fibrates, cyclosporins, labetalol, propofol, procainamide, interferon-alpha, hydroxyurea, zidovudine, colchicine, vincristine, amiodarone, corticosteroids) or that may affect CK elevation.
- Use of meldonium within the last 2 months.
Trial locations and contacts
1 site in 1 country.
Latvia1 site
University of Latvia (Faculty of Medicine and Institute of Cardiology and Regenerative Medicine)
Riga
About this study
Official title: Measurement of Acylcarnitine Levels and Mitochondrial Functionality in Connection With Statin-Induced Skeletal Muscle Myopathy
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. The main questions it aims to answer are:
Do patients with statin-associated muscle symptoms have higher acylcarnitine levels in blood and muscle compared to statin users without symptoms and people not taking statins? Do acylcarnitine levels decrease after stopping or reducing statin treatment in affected patients?
Read more
Researchers will compare patients with statin-associated muscle symptoms, statin users without symptoms, and individuals not taking statins to see if differences in acylcarnitine levels and muscle metabolism are associated with muscle symptoms.
Participants will:
Provide blood samples for biochemical tests and acylcarnitine analysis Share information about their health, medications, and lifestyle (Optional) undergo a muscle biopsy to study muscle metabolism Some participants with muscle symptoms will have repeat blood tests and possibly a repeat muscle biopsy after statin dose reduction or discontinuation to track changes over time
Read the detailed description
Statins are widely used lipid-lowering medications that reduce cardiovascular risk, but their use may be limited by statin-associated muscle symptoms (SAMS), which range from mild myalgia to significant elevations in creatine kinase (CK). The underlying biological mechanisms of SAMS are not fully understood. One proposed mechanism involves impaired mitochondrial fatty acid metabolism, which may lead to the accumulation of acylcarnitines-intermediate metabolites involved in fatty acid transport and oxidation within mitochondria.
This study aims to investigate whether statin-associated muscle symptoms are associated with disturbances in acylcarnitine metabolism in blood and skeletal muscle tissue. Specifically, the study will assess whether patients with SAMS have higher concentrations of acylcarnitines compared to statin users without muscle symptoms and individuals not receiving statin therapy, and whether these concentrations change after discontinuation or reduction of statin therapy.
This is a single-center observational case-control study conducted at the Latvian Cardiology Center of Pauls Stradiņš Clinical University Hospital. The study population includes three groups: (1) patients with elevated CK levels with or without muscle symptoms suggestive of statin-associated myopathy, (2) patients receiving stable high-dose statin therapy without muscle symptoms, and (3) control participants not using lipid-lowering therapy and without unexplained muscle symptoms.
All participants underwent a single study visit during which demographic data, medical history, medication use (including statins and other lipid-lowering therapies), and lifestyle factors (such as smoking, alcohol consumption, and physical activity) were recorded. Blood samples were collected for routine biochemical analyses (including CK, alanine aminotransferase, creatinine, and lipid profile) and for the measurement of plasma acylcarnitine concentrations. Plasma samples were processed and stored at -80°C for current and future analyses.
Participants were assessed for statin-associated muscle symptoms using the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI). In a subset of participants who provided additional informed consent, a muscle biopsy was performed under local anesthesia from the non-dominant forearm muscle. Muscle tissue samples were used to evaluate acylcarnitine concentrations and mitochondrial fatty acid metabolism.
Participants in the SAMS group (Group A) who required discontinuation or dose reduction of statin therapy as part of routine clinical care underwent prospective follow-up. Repeat blood sampling was performed approximately 4 and 8 weeks after statin discontinuation or dose adjustment, and continued at 4-week intervals (up to 24 weeks) until CK levels normalized. In selected participants, a repeat muscle biopsy was performed within 4-8 weeks after statin discontinuation or dose reduction to assess changes in mitochondrial metabolism and acylcarnitine concentrations.
Data will be analyzed to compare acylcarnitine concentrations between groups and to evaluate changes over time in the SAMS group. Quantitative variables will be summarized using means and standard deviations or medians and interquartile ranges, depending on data distribution. Between-group comparisons will be performed using parametric or non-parametric statistical tests as appropriate, and repeated measurements will be analyzed using paired statistical methods. A p-value <0.05 will be considered statistically significant.
The results of this study are expected to improve understanding of the pathophysiology of statin-associated muscle symptoms and may contribute to the development of better diagnostic and management strategies for patients experiencing statin intolerance.
- Conditions
- Statin Adverse Reaction, Statin-induced Myopathy
- Being tested
- Blood sampling and laboratory assessment, Muscle biopsy
- Keywords
- statins, myopathy, statin-induced myopathy, acylcarnitines
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and laboratory assessmentOther
Collection of blood samples for measurement of acylcarnitine concentrations and routine biochemistry, including creatine kinase and lipid profile.
Muscle biopsyOther
Optional muscle tissue sampling under local anesthesia from the non-dominant forearm muscle for assessment of acylcarnitine concentrations and mitochondrial fatty acid metabolism.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Statin-Associated Muscle Symptoms (SAM) | Adults with elevated creatine kinase (CK >1.5× upper limit of normal) with or without muscle symptoms that cannot be explained by other causes. Participants may continue using statins or may require statin discontinuation or dose reduction. Receives: Other: Blood sampling and laboratory assessment; Other: Muscle biopsy | |
| Group B: Statin Users Without Muscle Symptoms | Adults receiving stable high-dose statin monotherapy (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for at least 8 weeks, without muscle symptoms and with normal CK levels (<200 U/L). Receives: Other: Blood sampling and laboratory assessment; Other: Muscle biopsy | |
| Group C: Control Group (No Statin Use) | Adults who have not used any lipid-lowering therapy in the past year, have no unexplained muscle symptoms, and have normal CK levels (<200 U/L). Receives: Other: Blood sampling and laboratory assessment; Other: Muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acylcarnitine concentrations in blood
Comparison of plasma acylcarnitine levels between patients with statin-associated muscle symptoms, statin users without symptoms, and controls not using statins.
Measured: At baseline (single visit)
Acylcarnitine concentrations in muscle tissue
Comparison of acylcarnitine levels in muscle biopsy samples between study groups to assess differences in mitochondrial fatty acid metabolism.
Measured: At baseline (muscle biopsy visit)
Secondary outcomes (2)
Changes in acylcarnitine concentrations after statin discontinuation or dose reduction
Evaluation of changes in plasma acylcarnitine levels in patients with statin-associated muscle symptoms after stopping or reducing statin therapy.
Measured: Approximately 4 weeks and 8 weeks after statin discontinuation or dose reduction (up to 24 weeks if needed)
Changes in muscle acylcarnitine concentrations (subset of participants)
Evaluation of changes in muscle acylcarnitine levels in patients undergoing repeat muscle biopsy after statin discontinuation or dose reduction.
Measured: 4-8 weeks after statin discontinuation or dose reduction (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start22 Aug 2023
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin Adverse ReactionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Collaborators
- Latvian Institute of Organic Synthesis, University of Latvia
- Responsible party
- Principal investigator, Ilze Konrade, Riga Stradins University
- Investigators
- Gustavs Latkovskis, PhD, MD, Study chair, Faculty of Medicine, University of Latvia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511686
- Sponsor's protocol ID
- VPP-EM-BIOMEDICĪNA-2022/1-0001
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will deposit individual original measurement results, but not anthropometric data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Acylcarnitine Levels and Mitochondrial Functionality in Connection With Statin-Induced Skeletal Muscle Myopathy
- ClinicalTrials.gov ID
- NCT07511686
- Acronym / sponsor ID
- VPP-EM-BIOMEDICĪNA-2022/1-0001
- Conditions
- Statin Adverse Reaction, Statin-induced Myopathy
- Keywords
- statins, myopathy, statin-induced myopathy, acylcarnitines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Collaborators
- Latvian Institute of Organic Synthesis, University of Latvia
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. The main questions it aims to answer are:
Do patients with statin-associated muscle symptoms have higher acylcarnitine levels in blood and muscle compared to statin users without symptoms and people not taking statins? Do acylcarnitine levels decrease after stopping or reducing statin treatment in affected patients?
Researchers will compare patients with statin-associated muscle symptoms, statin users without symptoms, and individuals not taking statins to see if differences in acylcarnitine levels and muscle metabolism are associated with muscle symptoms.
Participants will:
Provide blood samples for biochemical tests and acylcarnitine analysis Share information about their health, medications, and lifestyle (Optional) undergo a muscle biopsy to study muscle metabolism Some participants with muscle symptoms will have repeat blood tests and possibly a repeat muscle biopsy after statin dose reduction or discontinuation to track changes over time
Detailed description
Statins are widely used lipid-lowering medications that reduce cardiovascular risk, but their use may be limited by statin-associated muscle symptoms (SAMS), which range from mild myalgia to significant elevations in creatine kinase (CK). The underlying biological mechanisms of SAMS are not fully understood. One proposed mechanism involves impaired mitochondrial fatty acid metabolism, which may lead to the accumulation of acylcarnitines-intermediate metabolites involved in fatty acid transport and oxidation within mitochondria.
This study aims to investigate whether statin-associated muscle symptoms are associated with disturbances in acylcarnitine metabolism in blood and skeletal muscle tissue. Specifically, the study will assess whether patients with SAMS have higher concentrations of acylcarnitines compared to statin users without muscle symptoms and individuals not receiving statin therapy, and whether these concentrations change after discontinuation or reduction of statin therapy.
This is a single-center observational case-control study conducted at the Latvian Cardiology Center of Pauls Stradiņš Clinical University Hospital. The study population includes three groups: (1) patients with elevated CK levels with or without muscle symptoms suggestive of statin-associated myopathy, (2) patients receiving stable high-dose statin therapy without muscle symptoms, and (3) control participants not using lipid-lowering therapy and without unexplained muscle symptoms.
All participants underwent a single study visit during which demographic data, medical history, medication use (including statins and other lipid-lowering therapies), and lifestyle factors (such as smoking, alcohol consumption, and physical activity) were recorded. Blood samples were collected for routine biochemical analyses (including CK, alanine aminotransferase, creatinine, and lipid profile) and for the measurement of plasma acylcarnitine concentrations. Plasma samples were processed and stored at -80°C for current and future analyses.
Participants were assessed for statin-associated muscle symptoms using the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI). In a subset of participants who provided additional informed consent, a muscle biopsy was performed under local anesthesia from the non-dominant forearm muscle. Muscle tissue samples were used to evaluate acylcarnitine concentrations and mitochondrial fatty acid metabolism.
Participants in the SAMS group (Group A) who required discontinuation or dose reduction of statin therapy as part of routine clinical care underwent prospective follow-up. Repeat blood sampling was performed approximately 4 and 8 weeks after statin discontinuation or dose adjustment, and continued at 4-week intervals (up to 24 weeks) until CK levels normalized. In selected participants, a repeat muscle biopsy was performed within 4-8 weeks after statin discontinuation or dose reduction to assess changes in mitochondrial metabolism and acylcarnitine concentrations.
Data will be analyzed to compare acylcarnitine concentrations between groups and to evaluate changes over time in the SAMS group. Quantitative variables will be summarized using means and standard deviations or medians and interquartile ranges, depending on data distribution. Between-group comparisons will be performed using parametric or non-parametric statistical tests as appropriate, and repeated measurements will be analyzed using paired statistical methods. A p-value <0.05 will be considered statistically significant.
The results of this study are expected to improve understanding of the pathophysiology of statin-associated muscle symptoms and may contribute to the development of better diagnostic and management strategies for patients experiencing statin intolerance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Statin-Associated Muscle Symptoms (SAM) | – | Other: Blood sampling and laboratory assessment, Other: Muscle biopsyAdults with elevated creatine kinase (CK >1.5× upper limit of normal) with or without muscle symptoms that cannot be explained by other causes. Participants may continue using statins or may require statin discontinuation or dose reduction. |
| Group B: Statin Users Without Muscle Symptoms | – | Other: Blood sampling and laboratory assessment, Other: Muscle biopsyAdults receiving stable high-dose statin monotherapy (atorvastatin 40-80 mg or rosuvastatin 20-40 mg) for at least 8 weeks, without muscle symptoms and with normal CK levels (<200 U/L). |
| Group C: Control Group (No Statin Use) | – | Other: Blood sampling and laboratory assessment, Other: Muscle biopsyAdults who have not used any lipid-lowering therapy in the past year, have no unexplained muscle symptoms, and have normal CK levels (<200 U/L). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult participants (≥18 years) of Caucasian ethnicity recruited at the Latvian Cardiology Center of Pauls Stradiņš Clinical University Hospital. The study includes three groups: (1) patients with elevated creatine kinase levels with or without muscle symptoms suggestive of statin-associated muscle myopathy, (2) patients receiving stable high-dose statin therapy without muscle symptoms, and (3) individuals not receiving lipid-lowering therapy and without unexplained muscle symptoms. Participants may be hospitalized patients or outpatients, including referrals from other medical institutions. All participants must provide written informed consent, and a subset of participants may additionally consent to undergo muscle biopsy for further analysis of mitochondrial metabolism in muscle tissue.
Key inclusion criteria (7 listed)
- Age at least 18 years.
- A representative of the Caucasian race.
- The patient agrees to participate in the study by signing an informed consent form for participation in the study. (The patient may only be included in the muscle biopsy sub-study if the relevant additional informed consent form has also been signed.)
- Specific inclusion criteria for each of the study subgroups:
Key exclusion criteria (12 listed)
- Any disease that, in the opinion of the investigator, could also cause a significant increase in CK or muscle symptoms.
- Use of other cholesterol-lowering agents specific to each of the study groups:
- Intense physical activity in the last 7 days.
- Acute myocardial infarction or stroke in the last 4 weeks.
- Major surgery within the last 4 weeks (invasive cardiac procedures are not an exclusion criterion).
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 |
|---|---|---|
| Blood sampling and laboratory assessmentCollection of blood samples for measurement of acylcarnitine concentrations and routine biochemistry, including creatine kinase and lipid profile. | Other | Group A: Statin-Associated Muscle Symptoms (SAM), Group B: Statin Users Without Muscle Symptoms, Group C: Control Group (No Statin Use) |
| Muscle biopsyOptional muscle tissue sampling under local anesthesia from the non-dominant forearm muscle for assessment of acylcarnitine concentrations and mitochondrial fatty acid metabolism. | Other | Group A: Statin-Associated Muscle Symptoms (SAM), Group B: Statin Users Without Muscle Symptoms, Group C: Control Group (No Statin Use) |
Primary outcome
Acylcarnitine concentrations in blood
Time frame: At baseline (single visit)
Comparison of plasma acylcarnitine levels between patients with statin-associated muscle symptoms, statin users without symptoms, and controls not using statins.
Acylcarnitine concentrations in muscle tissue
Time frame: At baseline (muscle biopsy visit)
Comparison of acylcarnitine levels in muscle biopsy samples between study groups to assess differences in mitochondrial fatty acid metabolism.
2 secondary outcomes
Changes in acylcarnitine concentrations after statin discontinuation or dose reduction
Time frame: Approximately 4 weeks and 8 weeks after statin discontinuation or dose reduction (up to 24 weeks if needed)
Changes in muscle acylcarnitine concentrations (subset of participants)
Time frame: 4-8 weeks after statin discontinuation or dose reduction (up to 24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. We will deposit individual original measurement results, but not anthropometric data.
Related trials for Statin Adverse Reaction
Recruiting
Exercise Intensity and Muscle Recovery in Statin Users
Statin Adverse Reaction
Not yet recruitingPhase 4
Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients
Anthracycline-induced Cardiac Toxicity, Breast Cancer
RecruitingPhase 2
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
Cardiac Toxicity, Early-stage Breast Cancer
RecruitingPhase 4
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Myocardial Infarction, Statin Adverse Reaction
RecruitingPhase 4
DESIFOR-EXPAND (MHIF)
Statin Therapy, Statin Adverse Reaction
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.
Gustavs Latkovskis, PhD, MD study chair
Faculty of Medicine, University of Latvia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Statin Adverse Reaction and Statin-induced Myopathy, run by Riga Stradins University at 1 site in Latvia.
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 7 inclusion and 12 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acylcarnitine concentrations in blood (time frame: At baseline (single visit)). 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?
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 6 Apr 2026.