DyslipidemiaCLARISKINCT07515573
Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals
A study testing Cardiol Forte in people with Dyslipidemia, run by U.G.A. Nutraceuticals at 1 site in Italy.
Trial summary
This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Cardiol Forte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 79 years
- Individuals in primary cardiovascular prevention
- Estimated 10-year cardiovascular risk <10%
- Screening non-HDL-C between 140 and 220 mg/dL, or screening LDL-C between 110 and 190 mg/dL
- Ability to communicate adequately, to be understood, and to comply with the study requirements
- Willingness to participate in the study and provision of written, signed, and dated informed consent
Who cannot join
- Triglycerides >400 mg/dL at screening
- Type 1 or type 2 diabetes mellitus
- Body mass index >35 kg/m²
- Current treatment with lipid-lowering drugs or use of dietary supplements active on lipid metabolism
- Antihypertensive treatment not stabilized for at least 3 months
- Known clinically significant alterations of thyroid, hepatic, and/or renal function
Show all 10Show fewer
- Women of childbearing potential not using adequate contraceptive methods
- Pregnancy or breastfeeding
- Any medical or surgical condition that, in the investigator's judgment, could make adherence to the protocol difficult or inconsistent, compromise participant safety, or interfere with study completion
- Known intolerance or hypersensitivity to any component of the study 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
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, BO, 40100
Arrigo Francesco Giuseppe Cicero, MD, PhD, +39051214290, arrigo.cicero@unibo.it
Valentina Di Micoli, BD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group Clinical Trial With an Open-Label Extension to Evaluate the Effects of a Combination Dietary Supplement (Cardiol Forte) on Lipid and Glycemic Parameters in Subjects at Low Cardiovascular Risk With Suboptimal Cholesterol Levels
This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. After a 14- to 28-day run-in period with standardized dietary and behavioral instructions, 50 participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will receive Cardiol Forte for an additional 8 weeks in an open-label extension. The primary objective is to compare the change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 8 between Cardiol Forte and placebo. Secondary objectives include evaluation of other lipid parameters, fasting plasma glucose, Omega-3 Index, selected inflammatory and liver-related markers, and endothelial reactivity.
Read the detailed description
This monocentric, randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. In routine clinical practice, many individuals in primary cardiovascular prevention have mildly to moderately altered lipid levels that do not necessarily require immediate pharmacological treatment, but may still benefit from non-pharmacological strategies aimed at improving cardiometabolic risk factors. Cardiol Forte contains omega-3 fatty acids, artichoke leaf extract, bergamot extract, olive extract standardized in hydroxytyrosol, coenzyme Q10, folic acid, and vitamin E, and may have favorable effects on lipid metabolism and related cardiometabolic parameters.
A total of 50 participants will be enrolled. After screening and a 14- to 28-day run-in period with standardized dietary and behavioral instructions, eligible participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will enter an 8-week open-label extension and will receive Cardiol Forte. Study product will be administered orally at a dose of 2 capsules per day, preferably 15 to 30 minutes before dinner. The total duration of participation will therefore be 16 weeks, in addition to the run-in period.
The primary objective is to compare the change in plasma non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to the end of the 8-week double-blind phase between Cardiol Forte and placebo. Secondary objectives include evaluation of changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglycerides, remnant cholesterol, fasting plasma glucose, Omega-3 Index, triglyceride-glucose index, liver-related indices, uric acid, high-sensitivity C-reactive protein, and endothelial reactivity. Participants will attend screening, randomization, end-of-double-blind, and final study visits. Blood samples for efficacy and safety assessments will be collected at scheduled visits, Omega-3 Index will be assessed at baseline, Week 8, and Week 16, and endothelial reactivity will be assessed by flow-mediated dilation. Safety will be monitored throughout the study through adverse event collection, vital signs, clinical assessments, and laboratory evaluations.
- Conditions
- Dyslipidemia
- Being tested
- Cardiol Forte, Placebo
- Keywords
- Cardiol Forte, Dyslipidemia, non-HDL cholesterol, Glycemic profile, Cardiovascular prevention, Low cardiovascular risk, Eicosapentaenoic acid, EPA, Docosahexaenoic acid, DHA, Artichoke, Bergamot, Hydroxytyrosol, Coenzyme Q10, Folic acid, Vitamin E
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiol ForteDietary supplement
Each capsule of Cardiol Forte contains fish oil 5025 TG 550.488 mg, corresponding to total omega-3 fatty acids 456 mg, of which eicosapentaenoic acid (EPA) 275 mg and docosahexaenoic acid (DHA) 137 mg; artichoke extract leaves (Altilix®) 150 mg; Citrus bergamia Risso et Poit. dry extract (BPF®) 100 mg; Cynara scolymus L. dry extract 10 mg; olive fruit dry extract standardized to 9% hydroxytyrosol 55.600 mg, corresponding to hydroxytyrosol 5.004 mg; coenzyme Q10 10 mg; folic acid 0.3 mg; and vitamin E 12 mg.
PlaceboOther
Matching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Weeks 0-8: double-blind phase; placebo, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily. Receives: Dietary Supplement: Cardiol Forte; Other: Placebo |
| Dietary supplement - Cardiol Forte | Experimental | Weeks 0-8: double-blind phase; Cardiol Forte, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily. Receives: Dietary Supplement: Cardiol Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)
Between-group comparison of the change from baseline in plasma non-HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Secondary outcomes (17)
Change from baseline in total cholesterol (TC)
Between-group comparison of the change from baseline in plasma TC after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
Between-group comparison of the change from baseline in plasma LDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in triglycerides (TG)
Between-group comparison of the change from baseline in plasma TG after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in high-density lipoprotein cholesterol (HDL-C)
Between-group comparison of the change from baseline in plasma HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in very-low-density lipoprotein cholesterol (VLDL-C)
Between-group comparison of the change from baseline in plasma VLDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in remnant cholesterol
Between-group comparison of the change from baseline in plasma remnant cholesterol after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in fasting plasma glucose
Between-group comparison of the change from baseline in fasting plasma glucose after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in Omega-3 Index
Between-group comparison of the change from baseline in Omega-3 Index after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in triglyceride-glucose index (TyG index)
Between-group comparison of the change from baseline in TyG index after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in aspartate aminotransferase (AST)
Between-group comparison of the change from baseline in plasma AST after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in alanine aminotransferase (ALT)
Between-group comparison of the change from baseline in plasma ALT after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in gamma-glutamyl transferase (gamma-GT)
Between-group comparison of the change from baseline in plasma gamma-GT after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in hepatic steatosis index (HSI)
Between-group comparison of the change from baseline in HSI after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in fatty liver index (FLI)
Between-group comparison of the change from baseline in FLI after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in uric acid
Between-group comparison of the change from baseline in plasma uric acid after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in high-sensitivity C-reactive protein (hs-CRP)
Between-group comparison of the change from baseline in plasma hs-CRP after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in endothelial reactivity
Between-group comparison of the change from baseline in endothelial reactivity after 8 weeks of double-blind treatment (Cardiol Forte versus placebo). Endothelial reactivity will be assessed by flow-mediated dilation.
Measured: Baseline to Week 8 (Day 56 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start4 May 2026 (estimated)
- Primary completion4 May 2028 (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 DyslipidemiaStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.G.A. Nutraceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515573
- Sponsor's protocol ID
- CLARISKI_RCT2026
- Acronym
- CLARISKI
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group Clinical Trial With an Open-Label Extension to Evaluate the Effects of a Combination Dietary Supplement (Cardiol Forte) on Lipid and Glycemic Parameters in Subjects at Low Cardiovascular Risk With Suboptimal Cholesterol Levels
- ClinicalTrials.gov ID
- NCT07515573
- Acronym / sponsor ID
- CLARISKI / CLARISKI_RCT2026
- Conditions
- Dyslipidemia
- Keywords
- Cardiol Forte, Dyslipidemia, non-HDL cholesterol, Glycemic profile, Cardiovascular prevention, Low cardiovascular risk, Eicosapentaenoic acid, EPA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- U.G.A. NutraceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 4 May 2028 (estimated)
- Study completion
- 4 May 2028 (estimated)
- First posted
- 7 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.
This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. After a 14- to 28-day run-in period with standardized dietary and behavioral instructions, 50 participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will receive Cardiol Forte for an additional 8 weeks in an open-label extension. The primary objective is to compare the change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 8 between Cardiol Forte and placebo. Secondary objectives include evaluation of other lipid parameters, fasting plasma glucose, Omega-3 Index, selected inflammatory and liver-related markers, and endothelial reactivity.
Detailed description
This monocentric, randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. In routine clinical practice, many individuals in primary cardiovascular prevention have mildly to moderately altered lipid levels that do not necessarily require immediate pharmacological treatment, but may still benefit from non-pharmacological strategies aimed at improving cardiometabolic risk factors. Cardiol Forte contains omega-3 fatty acids, artichoke leaf extract, bergamot extract, olive extract standardized in hydroxytyrosol, coenzyme Q10, folic acid, and vitamin E, and may have favorable effects on lipid metabolism and related cardiometabolic parameters.
A total of 50 participants will be enrolled. After screening and a 14- to 28-day run-in period with standardized dietary and behavioral instructions, eligible participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will enter an 8-week open-label extension and will receive Cardiol Forte. Study product will be administered orally at a dose of 2 capsules per day, preferably 15 to 30 minutes before dinner. The total duration of participation will therefore be 16 weeks, in addition to the run-in period.
The primary objective is to compare the change in plasma non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to the end of the 8-week double-blind phase between Cardiol Forte and placebo. Secondary objectives include evaluation of changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglycerides, remnant cholesterol, fasting plasma glucose, Omega-3 Index, triglyceride-glucose index, liver-related indices, uric acid, high-sensitivity C-reactive protein, and endothelial reactivity. Participants will attend screening, randomization, end-of-double-blind, and final study visits. Blood samples for efficacy and safety assessments will be collected at scheduled visits, Omega-3 Index will be assessed at baseline, Week 8, and Week 16, and endothelial reactivity will be assessed by flow-mediated dilation. Safety will be monitored throughout the study through adverse event collection, vital signs, clinical assessments, and laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Cardiol Forte, Other: PlaceboWeeks 0-8: double-blind phase; placebo, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily. |
| Dietary supplement - Cardiol Forte | Experimental | Dietary Supplement: Cardiol ForteWeeks 0-8: double-blind phase; Cardiol Forte, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18 to 79 years
- Individuals in primary cardiovascular prevention
- Estimated 10-year cardiovascular risk <10%
- Screening non-HDL-C between 140 and 220 mg/dL, or screening LDL-C between 110 and 190 mg/dL
- Ability to communicate adequately, to be understood, and to comply with the study requirements
Key exclusion criteria (10 listed)
- Triglycerides >400 mg/dL at screening
- Type 1 or type 2 diabetes mellitus
- Body mass index >35 kg/m²
- Current treatment with lipid-lowering drugs or use of dietary supplements active on lipid metabolism
- Antihypertensive treatment not stabilized for at least 3 months
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 |
|---|---|---|
| Cardiol ForteEach capsule of Cardiol Forte contains fish oil 5025 TG 550.488 mg, corresponding to total omega-3 fatty acids 456 mg, of which eicosapentaenoic acid (EPA) 275 mg and docosahexaenoic acid (DHA) 137 mg; artichoke extract leaves (Altilix®) 150 mg; Citrus bergamia Risso et Poit. dry extract (BPF®) 100 mg; Cynara scolymus L. dry extract 10 mg; olive fruit dry extract standardized to 9% hydroxytyrosol 55.600 mg, corresponding to hydroxytyrosol 5.004 mg; coenzyme Q10 10 mg; folic acid 0.3 mg; and vitamin E 12 mg. | Dietary supplement | Dietary supplement - Cardiol Forte, Placebo |
| PlaceboMatching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients. | Other | Placebo |
Primary outcome
Change from baseline in plasma non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Between-group comparison of the change from baseline in plasma non-HDL-C after 8 weeks of double-blind treatment (Cardiol Forte versus placebo).
17 secondary outcomes
Change from baseline in total cholesterol (TC)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in triglycerides (TG)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in very-low-density lipoprotein cholesterol (VLDL-C)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in remnant cholesterol
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in fasting plasma glucose
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in Omega-3 Index
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in triglyceride-glucose index (TyG index)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in aspartate aminotransferase (AST)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in alanine aminotransferase (ALT)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in gamma-glutamyl transferase (gamma-GT)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in hepatic steatosis index (HSI)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in fatty liver index (FLI)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in uric acid
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
Change from baseline in endothelial reactivity
Time frame: Baseline to Week 8 (Day 56 ± 3 days)
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 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiol Forte in people with Dyslipidemia, run by U.G.A. Nutraceuticals 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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 20 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 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 plasma non-high-density lipoprotein cholesterol (non-HDL-C) (time frame: Baseline to Week 8 (Day 56 ± 3 days)). 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 20 Apr 2026.