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Hypercholesterolemia and HyperlipidemiaNCT06810466

Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia

A study testing Test Product A and Test Product B in people with Hypercholesterolemia and Hyperlipidemia and Supplementation, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. Read more about this study

Who is it for?
Ages 18 to 69 years
What is being tested?
Test Product A and Test Product B
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteItaly
Study dates
17 Dec 2024to Jan 2026
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prevention of cardiovascular disease
  • Low cardiovascular risk (< 5%)
  • Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2
  • Signature of informed consent.

Who cannot join

  • Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk >/= 5)
  • diabetes mellitus
  • Taking hypolipemiants, supplements or drugs that may involve lipid metabolism
  • Hypertension treatment not stabilized for at least 3 months
  • History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease
  • Any medical-surgical treatment that may limit adherence to the study protocol
  • Pregnant and/or breastfeeding women

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Arrigo Francesco Giuseppe Cicero, Prof. contact

+39 512142224

arrigo.cicero@unibo.it

Italy1 site, 1 recruiting

  • S. Orsola-Malpighi University Hospital

    Bologna, Italy, 40138

    Arrigo F.G. Cicero, Prof., +39 512142224, arrigo.cicero@unibo.it

    Recruiting

Other trials in Italy

About this study

Official title: A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia

A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.

The study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:

Read more

Group A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo

The following visits are scheduled during the study:

T-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.

Being tested
Test Product A, Test Product B, Placebo
Keywords
mild hypercholesterolemia, supplement, lipid profile, dietary supplement
Medical subject headings
Hypercholesterolemia, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test Product ADietary supplement

    Innovative formulation of a dietary supplement for mild hypercholesterolemia. Test Product A will be admistered daily for 8 weeks. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.

  • Test Product BDietary supplement

    Classic formulation of a dietary supplement for mild hypercholesterolemia. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.

  • PlaceboDietary supplement

    Placebo does not contain functional components and is indistinguishable from Product Test B.

    After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.

Study groups in NCT06810466
Study groupRoleWhat they receive
Test Product AExperimentalInnovative formulation of dietary supplement
Receives: Dietary Supplement: Test Product A
Test Product BActive comparatorClassic formulation of dietary supplement
Receives: Dietary Supplement: Test Product B
PlaceboPlacebo comparatorPlacebo
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment

    Evaluation of absolute value change in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration (expressed as mg/dL), at 8 weeks (T1) of dietary supplementation with Test Product A vs baseline (T0).

    Measured: At baseline (T0) and at 8 weeks.

  2. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment

    Evaluation of the percentage variation (%) in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration at 8 weeks (T1) of dietary supplementation with Test Product A, compared to baseline (T0).

    Measured: At baseline (T0) and at 8 weeks.

Secondary outcomes (49)

  1. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B

    Evaluation of absolute value change in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration (expressed as mg/dL), at 8 weeks (T1) of dietary supplementation with Test Product B vs baseline (T0).

    Measured: At baseline (T0) and at 8 weeks.

  2. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B

    Evaluation of the percentage change (%) in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration at 8 weeks (T1) of dietary supplementation with Test Product B, compared to baseline (T0)

    Measured: At baseline (T0), and at 8 weeks (T1)

  3. Serum Total Cholesterol Concentration (TC)

    Evaluation of the absolute value change in Serum Total Cholesterol concentration (TC; expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  4. Serum Total Cholesterol Concentration (TC)

    Evaluation of the percentage change (%) in Serum Total Cholesterol concentration (TC) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  5. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration

    Evaluation of the absolute value change in serum concentrations of Low-Density Lipoprotein Cholesterol (LDL-C; expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  6. Low-Density Lipoprotein Cholesterol (LDL-C)

    Evaluation of the percentage change (%) in Low-Density Lipoprotein Cholesterol (LDL-C) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  7. High-Density Lipoprotein Cholesterol (HDL-C)

    Evaluation of the absolute value change in serum concentrations of High-Density Lipoprotein Cholesterol (HDL-C; expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  8. High-Density Lipoprotein Cholesterol (HDL-C)

    Evaluation of the percentage change (%) in serum concentrations of High-Density Lipoprotein Cholesterol (HDL-C) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  9. Non High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Evaluation of the absolute value change in serum concentrations of Non High-Density Lipoprotein Cholesterol (Non-HDL-C; expressed in mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  10. Non High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Evaluation of the percentage change (%) in serum concentrations of Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  11. Triglycerides (TG)

    Evaluation of absolute value change in Triglycerides (TG) serum concentration (expressed as mg/dL), at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  12. Triglycerides (TG)

    Evaluation of the percentage change (%) in serum concentrations of Triglycerides (TG) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  13. Apolipoprotein B

    Evaluation of the absolute value change in serum concentrations of Apolipoprotein B (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0)

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  14. Apolipoprotein B

    Evaluation of the percentage change (%) in serum concentrations of Apolipoprotein B at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  15. Systolic Blood Pressure

    Evaluation of the absolute value change in Systolic Blood Pressure (expressed as mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  16. Systolic Blood Pressure

    Evaluation of the percentage change (%) in Systolic Blood Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  17. Diastolic Blood Pressure

    Evaluation of the absolute value change in Diastolic Blood Pressure (expressed as mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  18. Diastolic Blood Pressure

    Evaluation of the percentage change (%) in Diastolic Blood Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  19. Mean Arterial Pressure

    Evaluation of the absolute change in Mean Arterial Pressure (expressed in mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  20. Mean Arterial Pressure

    Evaluation of the percentage change (%) in Mean Arterial Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  21. Pulse Pressure

    Evaluation of the absolute change in Pulse Pressure (expressed in mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  22. Pulse Pressure

    Evaluation of the percentage change (%) in Pulse Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  23. Flow-Mediated Dilation (FMD) - Endothelial Function

    Evaluation of the percentage change (%) in Flow-Mediated Dilation (FMD), measured as the percentage increase in artery diameter during hyperemia, at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0)

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  24. Body Weight

    Evaluation of the absolute value change in Weight (kg) at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  25. Body Weight

    Evaluation of the percentage change (%) Weight at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  26. Body Mass Index (BMI)

    Evaluation of the absolute value change in Body Mass Index (BMI; kg/m²), at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  27. Body Mass Index (BMI)

    Evaluation of the percentage change (%) in Body Mass Index (BMI), at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  28. Glutamic Oxaloacetic Transaminase (GOT)

    Evaluation of the absolute value change in Glutamic Oxaloacetic Transaminase (GOT) concentration (expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  29. Glutamic Oxaloacetic Transaminase (GOT)

    Evaluation of the percentage change (%) in Glutamic Oxaloacetic Transaminase concentration (GOT; expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  30. Gamma-Glutamyl Transferase (Gamma - GT)

    Evaluation of the absolute value change in Gamma-Glutamyl Transferase (Gamma - GT) concentration (expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  31. Gamma-Glutamyl Transferase (Gamma - GT)

    Evaluation of the percentage change (%) in Gamma-Glutamyl Transferase (Gamma - GT) concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  32. Glutamic Pyruvate Transaminase (GPT)

    Evaluation of the absolute value change in Glutamic Pyruvate Transaminase (GPT) concentration (expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  33. Glutamic Pyruvate Transaminase (GPT)

    Evaluation of the percentage change (%) in Glutamic Pyruvate Transaminase (GPT) concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  34. Serum Uric Acid

    Evaluation of the absolute value change in Serum Uric Acid concentration (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  35. Serum Uric Acid

    Evaluation of the percentage change (%) in Serum Uric Acid concentrations at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)

  36. Creatinine Concentration

    Evaluation of the absolute value change in Creatinine Concentration (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2).

  37. Creatinine Concentration

    Evaluation of the percentage change (%) in Creatinine Concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1) and 16 weeks (T2).

  38. Creatine phosphokinase (CPK) Concentration

    Evaluation of the absolute value change in Creatine Phosphokinase (CPK) concentration (expressed in mcg/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  39. Creatine phosphokinase (CPK) Concentration

    Evaluation of the percentage change (%) in Creatine Phosphokinase (CPK) concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  40. Number of subjects with LDL-C normal concentration

    Evaluation at 8 weeks (T1) and 16 weeks (T2) of the number of subjects in each group with LDL-C levels (mg/dL) within the normal range of concentration.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  41. Fasting Blood Glucose Concentration

    Evaluation of the absolute value change in Fasting Blood Glucose concentration (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  42. Fasting Blood Glucose Concentration

    Evaluation of the percentage change (%) in Fasting Blood Glucose concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  43. Cardiovascular Risk (CV)

    Assessment of the Cardiovascular Risk (CV), based on Cardiovascular Risk Chart, at 8 weeks (T1) and 16 weeks (T2), compared with baseline (T0).

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  44. Patients' compliance with the treatment

    Assessment of patient's compliance with the treatment by calculating the percentage ratio between the number of capsules taken and the number of capsules expected at 8 weeks (T1), and 16 weeks (T2), in each group and intergroup vs baseline (T0).

    Number of patients: 99; assigned treatment: Test Product A; Test product B; Placebo.

    Measured: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

  45. Patients' Tolerability of the assigned treatment

    Evaluation of Patients' Tolerability of the assigned treatment using the Visual Analogue Scale (VAS), with scores ranging from 1 to 10, where higher scores indicate greater tolerability, assessed at 8 weeks (T1) and 16 weeks (T2), with intra-group and inter-group evaluations.

    Number of patients: 99; assigned treatments: Test Product A, Test Product B, Placebo.

    Measured: At 8 weeks (T1) and at 16 weeks (T2)

  46. Patient acceptability of the assigned treatment

    Evaluation of patient acceptability of the assigned treatment using the Visual Analogue Scale (VAS), with scores ranging from 1 to 10, where higher scores indicate greater acceptability, assessed at 8 weeks (T1) and 16 weeks (T2), with intra-group and inter-group evaluations.

    Number of patients: 99; assigned treatments: Test Product A, Test Product B, Placebo.

    Measured: At 8 weeks (T1) and at 16 weeks (T2)

  47. Patients' adherence to diet

    Assessment of patients' adherence to diet based on the food history questionnaire recording at baseline (T0), 8 weeks (T1), 16 weeks (T2), and intra-group and intergroup evaluation.

    Measured: Baseline (T0), 8 weeks (T1), 16 weeks (T2)

  48. Implementation of patients' lifestyle

    Measurement of the rate of successful implementation of patients' lifestyle changes, through the evaluation of the prescription of physical exercise (brisk walking or cycling for 20-30 minutes, 3-5 times per week) by the investigator, assessed at baseline (T0), 8 weeks (T1), and 16 weeks (T2), with both intra-group and inter-group evaluations

    Measured: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)

  49. Monitoring of adverse events

    Collection of adverse events after treatment with product A, B and placebo

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start17 Dec 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind, parallel-group, randomized, placebo-controlled clinical trial, followed by an open label phase
Masking
Single blind
Who is masked
Participant
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810466
Sponsor's protocol ID
COLE_TRIAL_2023
Other IDs
COLE_TRIAL_2023
Status last verified
Jan 2025
First submitted
8 Jan 2025
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Results, data, workflows, and tools may be made available through publication, presentations at scientific meetings.

Questions about this trial

What is this clinical trial studying?

A study testing Test Product A and Test Product B in people with Hypercholesterolemia and Hyperlipidemia and Supplementation, run by IBSA Farmaceutici Italia Srl 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 4 inclusion and 7 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 Feb 2025. 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, Prof. (+39 512142224, arrigo.cicero@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment (time frame: At baseline (T0) and at 8 weeks.). 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 NCT06810466.

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 Feb 2025.

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