Polygenic HypercholesterolaemiaBENCHNCT07918677
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
A study testing Combined Dietary Supplement (Normolip® colesterolo) and Phytosterols in people with Polygenic Hypercholesterolaemia, run by ESI at 1 site in Italy.
Trial summary
Atherogenic dyslipidaemia is a key modifiable determinant of cardiovascular risk. Non-HDL-C provides a comprehensive estimate of atherogenic cholesterol burden. In primary prevention, adults with polygenic hypercholesterolaemia often require dietary and lifestyle interventions, but these may not yield sufficient lipid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Polygenic Hypercholesterolaemia
- What is being tested?
- Combined Dietary Supplement (Normolip® colesterolo) and Phytosterols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2026to 4 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years and ≤ 75 years old;
- Subjects in primary prevention for cardiovascular diseases;
- Estimated 10-year cardiovascular risk < 10%;
- Screening lipid levels meeting at least one of the following criteria:
- non-HDL cholesterol between 145 and 220 mg/dL, OR
- LDL cholesterol between 115 and 190 mg/dL;
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- Subjects willing to participate in the study and having dated and signed the informed consent form.
Who cannot join
- Triglycerides > 400 mg/dL at screening;
- Type 1 or type 2 diabetes mellitus;
- Current treatment with lipid-lowering drugs;
- Known clinically significant alterations of hepatic and/or renal function;
- Women of childbearing potential not using adequate contraceptive methods;
- Pregnancy and breastfeeding;
- Any medical or surgical condition that could make adherence to the protocol complex or inconsistent, or could compromise subject safety or the ability to complete the study;
- Known intolerance/hypersensitivity to any component of the investigational products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Italy, 40100
Arrigo Francesco Giuseppe Cicero, MD, PhD, +39051214290, arrigo.cicero@unibo.it
Marina Giovannini, BD
About this study
Official title: A Randomized, Double-Blind, Three-Arm, Placebo-Controlled Clinical Trial With Open-Label Extension to Evaluate the Efficacy of Phytosterols and a Combined Dietary Supplement (Normolip® Colesterolo) on Non-HDL Cholesterol
Atherogenic dyslipidaemia is a key modifiable determinant of cardiovascular risk. Non-HDL-C provides a comprehensive estimate of atherogenic cholesterol burden. In primary prevention, adults with polygenic hypercholesterolaemia often require dietary and lifestyle interventions, but these may not yield sufficient lipid improvements.
This study evaluates the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, versus placebo, on non-HDL-C change in adults with polygenic hypercholesterolaemia. The three-arm design assesses the primary placebo-controlled comparison and the incremental effect of the combined formulation.
Secondary analyses explore changes in lipid fractions and inflammatory indices. An open-label extension evaluates changes through 12 weeks. The goal is to provide evidence for well-tolerated adjunctive options for lipid management.
Read the detailed description
Atherogenic dyslipidaemia is a major modifiable determinant of cardiovascular risk in primary prevention. Although low-density lipoprotein cholesterol (LDL-C) is a key therapeutic target, non-high-density lipoprotein cholesterol (non-HDL-C) provides a more comprehensive estimate of atherogenic cholesterol burden because it includes cholesterol carried by all apoB-containing lipoproteins, including remnant lipoproteins. For this reason, non-HDL-C is a clinically relevant endpoint, particularly in individuals with mixed lipid patterns.
In routine practice, many adults present with a lipid phenotype consistent with polygenic hypercholesterolaemia, characterized by moderately elevated LDL-C and/or non-HDL-C in the absence of monogenic familial hypercholesterolaemia. In these subjects, especially when overall cardiovascular risk is low-to-moderate and pharmacological lipid-lowering therapy is not indicated or is deferred, lifestyle and dietary measures represent first-line management. However, lifestyle interventions may be insufficient to achieve meaningful lipid improvements in all individuals, supporting the need for well-tolerated adjunctive approaches suitable for real-world use.
Plant sterols (phytosterols) reduce intestinal cholesterol absorption and have demonstrated lipid-lowering effects. Additional natural compounds such as bergamot and artichoke extracts have been proposed to provide complementary actions on lipid metabolism, potentially enhancing the overall improvement in atherogenic cholesterol when combined with phytosterols. Nevertheless, comparative evidence directly benchmarking phytosterols alone versus a combined formulation and versus placebo under rigorous double-blind conditions is limited.
This study is designed to evaluate, in adults with polygenic hypercholesterolaemia in primary prevention, the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, compared with placebo, on change in non-HDL-C after 6 weeks of double-blind treatment. The three-arm design allows assessment of the primary placebo-controlled comparison and the incremental effect versus phytosterols alone. Secondary analyses will explore changes across the three arms in lipid fractions and selected inflammatory and liver-related indices (including hsCRP, RCII, LAP, HSI and FLI).
An open-label extension in which all participants receive the combined nutraceutical for a further 6 weeks is included to describe changes through 12 weeks and to characterize response patterns according to the initial randomized allocation under conditions closer to routine clinical use.
- Conditions
- Polygenic Hypercholesterolaemia
- Being tested
- Placebo, Combined Dietary Supplement (Normolip® colesterolo), Phytosterols
- Keywords
- Polygenic Hypercholesterolaemia, Primary Cardiovascular Prevention, Dietary Supplement, Food Supplement, Non-HDL-Cholesterol, Phytosterols, Bergamot dry extract, Artichoke dry extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Participants will take two tablets orally once daily, preferably with a main meal, during Phase 1 (weeks 0-6). Placebo tablets are matched in appearance, packaging, and labelling to the active study products.
Combined Dietary Supplement (Normolip® colesterolo)Dietary supplement
Participants will take two tablets orally once daily, preferably with a main meal. During Phase 1 (weeks 0-6), this intervention is administered according to randomization (Normolip® colesterolo). During Phase 2 (weeks 6-12), all participants will receive the combined dietary supplement (Normolip® colesterolo) in an open-label extension. Each tablet contains 800 mg plant sterols, 170 mg bergamot dry extract (standardized to 36% flavanones; corresponding to naringin 61.2 mg), and 50 mg artichoke dry extract (standardized to 2.5% caffeoylquinic acids as chlorogenic acid; corresponding to chlorogenic acid 1.25 mg).
PhytosterolsDietary supplement
Participants will take two tablets orally once daily, preferably with a main meal, during Phase 1 (weeks 0-6). Each tablet contains 800 mg of plant sterols.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Weeks 0-6: placebo, 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. Receives: Other: Placebo; Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo) |
| Dietary supplement - Phytosterols | Active comparator | Weeks 0-6: phytosterols, 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. Receives: Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo); Dietary Supplement: Phytosterols |
| Dietary supplement - Combined dietary supplement (Normolip® colesterolo) | Active comparator | Weeks 0-6: combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. Receives: Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in non-HDL cholesterol at 6 weeks (Day 42)
Change in non-HDL cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing combined nutraceutical versus placebo.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Secondary outcomes (10)
Change from baseline in total cholesterol at 6 weeks (Day 42)
Change in plasma total cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in HDL-C at 6 weeks (Day 42)
Change in plasma HDL cholesterol (HDL-C) from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in triglycerides at 6 weeks (Day 42)
Change in plasma triglycerides from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in LDL-C at 6 weeks (Day 42)
Change in plasma LDL cholesterol (LDL-C) from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in remnant cholesterol at 6 weeks (Day 42)
Change in plasma remnant cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in high-sensitivity C-reactive protein (hsCRP) at 6 weeks (Day 42)
Change in plasma hsCRP from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Remnant Cholesterol Inflammatory Index (RCII) at 6 weeks (Day 42)
Change in RCII from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Lipid Accumulation Product (LAP) at 6 weeks (Day 42)
Change in LAP from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Hepatic Steatosis Index (HSI) at 6 weeks (Day 42)
Change in HSI from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Fatty Liver Index (FLI) at 6 weeks (Day 42)
Change in FLI from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Measured: Baseline (T0) to 6 weeks (T1, Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Oct 2026
- Primary completion4 Nov 2027 (estimated)
- Study completion4 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polygenic HypercholesterolaemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ESI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918677
- Sponsor's protocol ID
- BENCH_RCT2026
- Acronym
- BENCH
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Three-Arm, Placebo-Controlled Clinical Trial With Open-Label Extension to Evaluate the Efficacy of Phytosterols and a Combined Dietary Supplement (Normolip® Colesterolo) on Non-HDL Cholesterol
- ClinicalTrials.gov ID
- NCT07918677
- Acronym / sponsor ID
- BENCH / BENCH_RCT2026
- Conditions
- Polygenic Hypercholesterolaemia
- Keywords
- Polygenic Hypercholesterolaemia, Primary Cardiovascular Prevention, Dietary Supplement, Food Supplement, Non-HDL-Cholesterol, Phytosterols, Bergamot dry extract, Artichoke dry extract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ESIIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- 4 Nov 2027 (estimated)
- Study completion
- 4 May 2028 (estimated)
- First posted
- 5 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.
Atherogenic dyslipidaemia is a key modifiable determinant of cardiovascular risk. Non-HDL-C provides a comprehensive estimate of atherogenic cholesterol burden. In primary prevention, adults with polygenic hypercholesterolaemia often require dietary and lifestyle interventions, but these may not yield sufficient lipid improvements.
This study evaluates the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, versus placebo, on non-HDL-C change in adults with polygenic hypercholesterolaemia. The three-arm design assesses the primary placebo-controlled comparison and the incremental effect of the combined formulation.
Secondary analyses explore changes in lipid fractions and inflammatory indices. An open-label extension evaluates changes through 12 weeks. The goal is to provide evidence for well-tolerated adjunctive options for lipid management.
Detailed description
Atherogenic dyslipidaemia is a major modifiable determinant of cardiovascular risk in primary prevention. Although low-density lipoprotein cholesterol (LDL-C) is a key therapeutic target, non-high-density lipoprotein cholesterol (non-HDL-C) provides a more comprehensive estimate of atherogenic cholesterol burden because it includes cholesterol carried by all apoB-containing lipoproteins, including remnant lipoproteins. For this reason, non-HDL-C is a clinically relevant endpoint, particularly in individuals with mixed lipid patterns.
In routine practice, many adults present with a lipid phenotype consistent with polygenic hypercholesterolaemia, characterized by moderately elevated LDL-C and/or non-HDL-C in the absence of monogenic familial hypercholesterolaemia. In these subjects, especially when overall cardiovascular risk is low-to-moderate and pharmacological lipid-lowering therapy is not indicated or is deferred, lifestyle and dietary measures represent first-line management. However, lifestyle interventions may be insufficient to achieve meaningful lipid improvements in all individuals, supporting the need for well-tolerated adjunctive approaches suitable for real-world use.
Plant sterols (phytosterols) reduce intestinal cholesterol absorption and have demonstrated lipid-lowering effects. Additional natural compounds such as bergamot and artichoke extracts have been proposed to provide complementary actions on lipid metabolism, potentially enhancing the overall improvement in atherogenic cholesterol when combined with phytosterols. Nevertheless, comparative evidence directly benchmarking phytosterols alone versus a combined formulation and versus placebo under rigorous double-blind conditions is limited.
This study is designed to evaluate, in adults with polygenic hypercholesterolaemia in primary prevention, the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, compared with placebo, on change in non-HDL-C after 6 weeks of double-blind treatment. The three-arm design allows assessment of the primary placebo-controlled comparison and the incremental effect versus phytosterols alone. Secondary analyses will explore changes across the three arms in lipid fractions and selected inflammatory and liver-related indices (including hsCRP, RCII, LAP, HSI and FLI).
An open-label extension in which all participants receive the combined nutraceutical for a further 6 weeks is included to describe changes through 12 weeks and to characterize response patterns according to the initial randomized allocation under conditions closer to routine clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo, Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo)Weeks 0-6: placebo, 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. |
| Dietary supplement - Phytosterols | Active comparator | Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo), Dietary Supplement: PhytosterolsWeeks 0-6: phytosterols, 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. |
| Dietary supplement - Combined dietary supplement (Normolip® colesterolo) | Active comparator | Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo)Weeks 0-6: combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged ≥ 18 years and ≤ 75 years old;
- Subjects in primary prevention for cardiovascular diseases;
- Estimated 10-year cardiovascular risk < 10%;
- Screening lipid levels meeting at least one of the following criteria:
- non-HDL cholesterol between 145 and 220 mg/dL, OR
Key exclusion criteria (8 listed)
- Triglycerides > 400 mg/dL at screening;
- Type 1 or type 2 diabetes mellitus;
- Current treatment with lipid-lowering drugs;
- Known clinically significant alterations of hepatic and/or renal function;
- Women of childbearing potential not using adequate contraceptive methods;
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 |
|---|---|---|
| PlaceboParticipants will take two tablets orally once daily, preferably with a main meal, during Phase 1 (weeks 0-6). Placebo tablets are matched in appearance, packaging, and labelling to the active study products. | Other | Placebo |
| Combined Dietary Supplement (Normolip® colesterolo)Participants will take two tablets orally once daily, preferably with a main meal. During Phase 1 (weeks 0-6), this intervention is administered according to randomization (Normolip® colesterolo). During Phase 2 (weeks 6-12), all participants will receive the combined dietary supplement (Normolip® colesterolo) in an open-label extension. Each tablet contains 800 mg plant sterols, 170 mg bergamot dry extract (standardized to 36% flavanones; corresponding to naringin 61.2 mg), and 50 mg artichoke dry extract (standardized to 2.5% caffeoylquinic acids as chlorogenic acid; corresponding to chlorogenic acid 1.25 mg). | Dietary supplement | Dietary supplement - Combined dietary supplement (Normolip® colesterolo), Dietary supplement - Phytosterols, Placebo |
| PhytosterolsParticipants will take two tablets orally once daily, preferably with a main meal, during Phase 1 (weeks 0-6). Each tablet contains 800 mg of plant sterols. | Dietary supplement | Dietary supplement - Phytosterols |
Primary outcome
Change from baseline in non-HDL cholesterol at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change in non-HDL cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing combined nutraceutical versus placebo.
10 secondary outcomes
Change from baseline in total cholesterol at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in HDL-C at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in triglycerides at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in LDL-C at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in remnant cholesterol at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in high-sensitivity C-reactive protein (hsCRP) at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Remnant Cholesterol Inflammatory Index (RCII) at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Lipid Accumulation Product (LAP) at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Hepatic Steatosis Index (HSI) at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Fatty Liver Index (FLI) at 6 weeks (Day 42)
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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 Combined Dietary Supplement (Normolip® colesterolo) and Phytosterols in people with Polygenic Hypercholesterolaemia, run by ESI at 1 site in Italy.
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 8 inclusion and 8 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 5 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 Italy. 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.
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 Arrigo Francesco Giuseppe Cicero, MD, PhD (+39051214290, arrigo.cicero@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in non-HDL cholesterol at 6 weeks (Day 42) (time frame: Baseline (T0) to 6 weeks (T1, Day 42)). 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 5 Nov 2026.