OverweightNCT07910916
Effects of Concurrent Training on Serum PCSK9 Levels in Adults With Overweight
A study testing Concurrent Aerobic and Resistance Training in people with Overweight and Lipid Metabolism, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Being overweight can increase the risk of heart disease. PCSK9 is a protein that helps regulate cholesterol levels in the blood. Exercise may affect PCSK9 levels, but previous studies have reported conflicting results. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Lipid Metabolism, Cholesterol Metabolism
- What is being tested?
- Concurrent Aerobic and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-40 years.
- Body mass index (BMI) between 25.0 and 29.9 kg/m².
- No participation in a regular exercise program during the previous two months (3-5 days per week, totaling 150 minutes per week).
Who cannot join
- Diagnosed coronary artery disease, heart failure, hypertension, diabetes mellitus, or other chronic cardiovascular or metabolic diseases.
- Acute or chronic inflammatory disease or active infection.
- History of malignancy or active cancer.
- Neurological, orthopedic, or musculoskeletal conditions that prevent participation in physical exercise.
- Current use of antihypertensive, lipid-lowering, antidiabetic, systemic glucocorticoid, or other medications that may affect PCSK9 levels.
- Current smoking or use of other tobacco products.
Show all 9Show fewer
- Pregnancy or breastfeeding.
- Loss of 5% or more of body weight during the previous three months or participation in a weight-loss diet.
- Bariatric surgery or use of pharmacological weight-management treatment during the previous three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kastamonu University, Çatalzeytin Vocational School
Çatalzeytin, Kastamonu, 37940
Yasin Ak, +903662801000 ext. 4505, yasinak@kastamonu.edu.tr
About this study
Official title: Effects of Concurrent Training on Serum PCSK9 Levels in Adults With Overweight: A Randomized Controlled Trial
Being overweight can increase the risk of heart disease. PCSK9 is a protein that helps regulate cholesterol levels in the blood. Exercise may affect PCSK9 levels, but previous studies have reported conflicting results.
The purpose of this study is to determine whether a program combining aerobic exercise and resistance training changes blood PCSK9 levels in adults with overweight. The researchers will also examine changes in blood cholesterol levels and body composition.
Read more
A total of 42 adults aged 18-40 years with overweight will be randomly assigned to one of two groups. One group will participate in a supervised exercise program three days per week for eight weeks. Each session will last approximately 60 minutes and include aerobic exercise, resistance training, warm-up, and cool-down periods. The other group will continue their usual daily activities without participating in a structured exercise program provided by the study.
Blood samples and body measurements will be collected before the program, after four weeks, and after eight weeks. Participants will also record their usual food intake and physical activity during the study.
The researchers expect that the combined exercise program may reduce blood PCSK9 levels compared with maintaining usual daily activities. The findings may help improve understanding of how exercise affects cholesterol regulation in adults with overweight.
Read the detailed description
Background and Rationale
Overweight is associated with an increased risk of cardiovascular disease, partly through adverse changes in blood lipid levels. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a protein involved in cholesterol regulation. It binds to low-density lipoprotein receptors (LDLR) and promotes their degradation, thereby reducing the removal of low-density lipoprotein cholesterol (LDL-C) from the bloodstream.
Regular exercise is an important lifestyle strategy for improving cardiovascular health and lipid metabolism. Previous research suggests that exercise may influence circulating PCSK9 levels, potentially contributing to changes in cholesterol regulation. However, studies investigating the effects of physical activity and exercise on PCSK9 have reported conflicting findings, with some showing reductions and others reporting increases. Therefore, the effects of structured exercise training on circulating PCSK9 levels remain unclear.
Study Objectives
The primary objective of this study is to investigate the effects of an eight-week concurrent aerobic and resistance training program on serum PCSK9 levels in adults with overweight, compared with a control group maintaining their usual daily activities.
The study will also examine changes in blood lipid levels, glucose concentrations, anthropometric measurements, and body composition. Additionally, the relationship between serum PCSK9 levels and body composition will be investigated.
Study Design and Procedures
This study is designed as a single-center, two-arm, parallel-group randomized controlled trial. Participants will be randomly allocated to either a supervised concurrent training group or a non-exercising control group using block randomization with a 1:1 allocation ratio.
The exercise program will combine aerobic and resistance training under professional supervision. Participants in the control group will be asked to maintain their usual daily activities without receiving a structured exercise intervention.
Biochemical, anthropometric, and body composition assessments will be performed at baseline, 4 and 8 weeks after baseline. Blood samples will be collected after an overnight fast to assess serum PCSK9 and metabolic markers.
To help account for potential changes in lifestyle behaviors, dietary intake and habitual physical activity will be monitored throughout the study using three-day dietary records and three-day physical activity records at the specified assessment periods.
Expected Contribution
This study is expected to provide evidence regarding the effects of concurrent aerobic and resistance training on circulating PCSK9 levels in adults with overweight. The findings may contribute to a better understanding of the relationship between exercise, PCSK9, and cholesterol metabolism and may help inform future research on exercise-based approaches to cardiovascular risk management.
- Conditions
- Overweight, Lipid Metabolism, Cholesterol Metabolism
- Being tested
- Concurrent Aerobic and Resistance Training
- Keywords
- PCSK9, Concurrent training, Aerobic Exercise, Resistance Training, Overweight, LDL Cholesterol
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Aerobic and Resistance TrainingBehavioural
Participants in the intervention group will complete an eight-week supervised concurrent aerobic and resistance training program, consisting of three sessions per week. Each 60-minute session will include a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance exercise, and a 5-minute cool-down.
Aerobic exercise will be performed on a treadmill or cycle ergometer at 40-60% of heart rate reserve.
Resistance training will include eight exercises targeting major muscle groups: chest press, lat pull-down, hamstring curl, quadriceps extension, shoulder press, biceps curl, triceps extension, and abdominal crunch. Participants will perform two sets of 8-16 repetitions at 50-80% of their 10-repetition maximum, with approximately one minute of rest between sets.
All sessions will be conducted under professional supervision. Heart rate and perceived exertion will be monitored during exercise using a heart rate monitor and the Borg Rating of Perceived Exertion Scale.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Training Group | Experimental | Participants assigned to this group will perform supervised concurrent aerobic and resistance training three times per week for eight weeks. Receives: Behavioral: Concurrent Aerobic and Resistance Training |
| Control Group | No intervention | Participants assigned to the control group will not receive a structured exercise intervention. They will be instructed to maintain their usual physical activity, dietary habits, and daily routines throughout the eight-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum PCSK9 Concentration
Serum PCSK9 concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Changes over time will be compared between the concurrent training and control groups.
Measured: At baseline and 4 and 8 weeks after baseline
Secondary outcomes (15)
Change in Serum LDL Cholesterol Concentration
Serum low-density lipoprotein cholesterol (LDL-C) concentration will be assessed from fasting blood samples. Changes over time will be compared between the concurrent training and control groups.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Serum HDL Cholesterol Concentration
Serum high-density lipoprotein cholesterol (HDL-C) concentration will be assessed from fasting blood samples. Changes over time will be compared between the concurrent training and control groups.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Serum Total Cholesterol Concentration
Serum total cholesterol concentration will be measured from fasting blood samples using an enzymatic colorimetric method. Changes over time will be compared between groups.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Serum Triglyceride Concentration
Serum triglyceride concentration will be measured from fasting blood samples using an enzymatic colorimetric method. Changes over time will be compared between groups.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Fasting Serum Glucose Concentration
Fasting serum glucose concentration will be measured using an enzymatic colorimetric method. Changes over time will be compared between groups.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Body Weight
Body weight will be measured in kilograms (kg) using a digital scale (Tanita RD-545).
Measured: At baseline and 4 and 8 weeks after baseline
Change in Body Mass Index
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Measured: At baseline and 4 and 8 weeks after baseline
Change in Waist Circumference
Waist circumference will be measured in centimeters (cm) at the midpoint between the lowest rib and iliac crest.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Hip Circumference
Hip circumference will be measured in centimeters (cm) at the widest part of the hips.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Hip Ratio
Waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. The ratio is dimensionless.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Height Ratio
Waist-to-height ratio will be calculated by dividing waist circumference by height, expressed in the same units. The ratio is dimensionless.
Measured: At baseline and 4 and 8 weeks after baseline
Change in Body Fat Percentage
Body fat percentage (%) will be assessed using bioelectrical impedance analysis (Tanita RD-545).
Measured: At baseline and 4 and 8 weeks after baseline
Change in Fat Mass
Total body fat mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).
Measured: At baseline and 4 and 8 weeks after baseline
Change in Fat-Free Mass
Fat-free mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).
Measured: At baseline and 4 and 8 weeks after baseline
Change in Muscle Mass
Muscle mass will be assessed in kilograms (kg) using bioelectrical impedance analysis (Tanita RD-545).
Measured: At baseline and 4 and 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Ak, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910916
- Sponsor's protocol ID
- KÜBAP2-01/2026-36
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers. The informed consent form provides for the use and processing of participant data for the approved study but does not explicitly address secondary data sharing with external researchers.
Publications
Smart NA, Downes D, van der Touw T, Hada S, Dieberg G, Pearson MJ, Wolden M, King N, Goodman SPJ. The Effect of Exercise Training on Blood Lipids: A Systematic Review and Meta-analysis. Sports Med. 2025 Jan;55(1):67-78. doi: 10.1007/s40279-024-02115-z. Epub 2024 Sep 27.
PubMed 39331324Kamani CH, Gencer B, Montecucco F, Courvoisier D, Vuilleumier N, Meyer P, Mach F. Stairs instead of elevators at the workplace decreases PCSK9 levels in a healthy population. Eur J Clin Invest. 2015 Oct;45(10):1017-24. doi: 10.1111/eci.12480. Epub 2015 Aug 26.
PubMed 26081791
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent Training on Serum PCSK9 Levels in Adults With Overweight: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07910916
- Acronym / sponsor ID
- KÜBAP2-01/2026-36
- Conditions
- Overweight, Lipid Metabolism, Cholesterol Metabolism
- Keywords
- PCSK9, Concurrent training, Aerobic Exercise, Resistance Training, Overweight, LDL Cholesterol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Nov 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.
Being overweight can increase the risk of heart disease. PCSK9 is a protein that helps regulate cholesterol levels in the blood. Exercise may affect PCSK9 levels, but previous studies have reported conflicting results.
The purpose of this study is to determine whether a program combining aerobic exercise and resistance training changes blood PCSK9 levels in adults with overweight. The researchers will also examine changes in blood cholesterol levels and body composition.
A total of 42 adults aged 18-40 years with overweight will be randomly assigned to one of two groups. One group will participate in a supervised exercise program three days per week for eight weeks. Each session will last approximately 60 minutes and include aerobic exercise, resistance training, warm-up, and cool-down periods. The other group will continue their usual daily activities without participating in a structured exercise program provided by the study.
Blood samples and body measurements will be collected before the program, after four weeks, and after eight weeks. Participants will also record their usual food intake and physical activity during the study.
The researchers expect that the combined exercise program may reduce blood PCSK9 levels compared with maintaining usual daily activities. The findings may help improve understanding of how exercise affects cholesterol regulation in adults with overweight.
Detailed description
Background and Rationale
Overweight is associated with an increased risk of cardiovascular disease, partly through adverse changes in blood lipid levels. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a protein involved in cholesterol regulation. It binds to low-density lipoprotein receptors (LDLR) and promotes their degradation, thereby reducing the removal of low-density lipoprotein cholesterol (LDL-C) from the bloodstream.
Regular exercise is an important lifestyle strategy for improving cardiovascular health and lipid metabolism. Previous research suggests that exercise may influence circulating PCSK9 levels, potentially contributing to changes in cholesterol regulation. However, studies investigating the effects of physical activity and exercise on PCSK9 have reported conflicting findings, with some showing reductions and others reporting increases. Therefore, the effects of structured exercise training on circulating PCSK9 levels remain unclear.
Study Objectives
The primary objective of this study is to investigate the effects of an eight-week concurrent aerobic and resistance training program on serum PCSK9 levels in adults with overweight, compared with a control group maintaining their usual daily activities.
The study will also examine changes in blood lipid levels, glucose concentrations, anthropometric measurements, and body composition. Additionally, the relationship between serum PCSK9 levels and body composition will be investigated.
Study Design and Procedures
This study is designed as a single-center, two-arm, parallel-group randomized controlled trial. Participants will be randomly allocated to either a supervised concurrent training group or a non-exercising control group using block randomization with a 1:1 allocation ratio.
The exercise program will combine aerobic and resistance training under professional supervision. Participants in the control group will be asked to maintain their usual daily activities without receiving a structured exercise intervention.
Biochemical, anthropometric, and body composition assessments will be performed at baseline, 4 and 8 weeks after baseline. Blood samples will be collected after an overnight fast to assess serum PCSK9 and metabolic markers.
To help account for potential changes in lifestyle behaviors, dietary intake and habitual physical activity will be monitored throughout the study using three-day dietary records and three-day physical activity records at the specified assessment periods.
Expected Contribution
This study is expected to provide evidence regarding the effects of concurrent aerobic and resistance training on circulating PCSK9 levels in adults with overweight. The findings may contribute to a better understanding of the relationship between exercise, PCSK9, and cholesterol metabolism and may help inform future research on exercise-based approaches to cardiovascular risk management.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent Training Group | Experimental | Behavioral: Concurrent Aerobic and Resistance TrainingParticipants assigned to this group will perform supervised concurrent aerobic and resistance training three times per week for eight weeks. |
| Control Group | No intervention | –Participants assigned to the control group will not receive a structured exercise intervention. They will be instructed to maintain their usual physical activity, dietary habits, and daily routines throughout the eight-week study period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-40 years.
- Body mass index (BMI) between 25.0 and 29.9 kg/m².
- No participation in a regular exercise program during the previous two months (3-5 days per week, totaling 150 minutes per week).
Key exclusion criteria (9 listed)
- Diagnosed coronary artery disease, heart failure, hypertension, diabetes mellitus, or other chronic cardiovascular or metabolic diseases.
- Acute or chronic inflammatory disease or active infection.
- History of malignancy or active cancer.
- Neurological, orthopedic, or musculoskeletal conditions that prevent participation in physical exercise.
- Current use of antihypertensive, lipid-lowering, antidiabetic, systemic glucocorticoid, or other medications that may affect PCSK9 levels.
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 |
|---|---|---|
| Concurrent Aerobic and Resistance TrainingParticipants in the intervention group will complete an eight-week supervised concurrent aerobic and resistance training program, consisting of three sessions per week. Each 60-minute session will include a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance exercise, and a 5-minute cool-down. Aerobic exercise will be performed on a treadmill or cycle ergometer at 40-60% of heart rate reserve. Resistance training will include eight exercises targeting major muscle groups: chest press, lat pull-down, hamstring curl, quadriceps extension, shoulder press, biceps curl, triceps extension, and abdominal crunch. Participants will perform two sets of 8-16 repetitions at 50-80% of their 10-repetition maximum, with approximately one minute of rest between sets. All sessions will be conducted under professional supervision. Heart rate and perceived exertion will be monitored during exercise using a heart rate monitor and the Borg Rating of Perceived Exertion Scale. | Behavioural | Concurrent Training Group |
Primary outcome
Change in Serum PCSK9 Concentration
Time frame: At baseline and 4 and 8 weeks after baseline
Serum PCSK9 concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Changes over time will be compared between the concurrent training and control groups.
15 secondary outcomes
Change in Serum LDL Cholesterol Concentration
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum HDL Cholesterol Concentration
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum Total Cholesterol Concentration
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Serum Triglyceride Concentration
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Fasting Serum Glucose Concentration
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Body Weight
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Body Mass Index
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Waist Circumference
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Hip Circumference
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Hip Ratio
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Waist-to-Height Ratio
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Body Fat Percentage
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Fat Mass
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Fat-Free Mass
Time frame: At baseline and 4 and 8 weeks after baseline
Change in Muscle Mass
Time frame: At baseline and 4 and 8 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 39331324Smart NA, Downes D, van der Touw T, Hada S, Dieberg G, Pearson MJ, Wolden M, King N, Goodman SPJ. The Effect of Exercise Training on Blood Lipids: A Systematic Review and Meta-analysis. Sports Med. 2025 Jan;55(1):67-78. doi: 10.1007/s40279-024-02115-z. Epub 2024 Sep 27.
- Background: PubMed 26081791Kamani CH, Gencer B, Montecucco F, Courvoisier D, Vuilleumier N, Meyer P, Mach F. Stairs instead of elevators at the workplace decreases PCSK9 levels in a healthy population. Eur J Clin Invest. 2015 Oct;45(10):1017-24. doi: 10.1111/eci.12480. Epub 2015 Aug 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers. The informed consent form provides for the use and processing of participant data for the approved study but does not explicitly address secondary data sharing with external researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Aerobic and Resistance Training in people with Overweight and Lipid Metabolism, run by Kastamonu University at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasin Ak, PhD (+90 538 443 96 25, fztyaso5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum PCSK9 Concentration (time frame: At baseline and 4 and 8 weeks after baseline). 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 NCT07910916, 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 3 Nov 2026.