HypercholesterolemiaPhase 1/2LipibackNCT02989753

Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

A Phase 1/2 study testing VAL070-A and VAL070-B in people with Hypercholesterolemia and Hypertriglyceridemia, run by Valbiotis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in this specific population. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia, Hypertriglyceridemia
What is being tested?: VAL070-A and VAL070-B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteFrance
Study dates: Jan 2017to Jul 2018
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age between 18 and 70 years (limits included),
BMI between 18.5 and 40 kg/m2 (limits included),
For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel and estrogen/progestin combination contraception accepted) or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded),
Weight stable within ± 5 % in the last three months,
Non smoking or with tobacco consumption < 20 cigarettes / day,
Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,

Show all 14Show fewer

Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
Affiliated with a social security scheme,
Agree to be registered on the volunteers in biomedical research file.
After V1 biological analysis the subjects will be eligible to the study on the following criteria:
Fasting blood LDLc level (using Friedewald estimation method) between 1.3 and 2.2 g/L (limits included with ± 2 % tolerated around),
Fasting blood triglycerides level > 1.5 g/L,
Blood TSH level between 0.27 and 4.2 μIU/mL (limits included).
Within 3 months following to the exit of the study for failure to comply to one or more of the inclusion criteria listed above, a re-screening could be performed.

Who cannot join

Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
With a history of ischemic cardiovascular event,
Having undergone recent surgical procedure (less than 6 months),
Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,

Show all 32Show fewer

Pregnant or lactating women or intending to become pregnant within 3 months ahead,
For women: pregnancy or breastfeeding finished since less than 6 months,
Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the V1 visit,
Requiring a cholesterol lowering by immediate pharmacologic intervention according to the current recommendations (AFSSAPS, 2005),
Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducer, etc.) or stopped less than 3 months before the randomization (antihypertensive stable long-term treatment tolerated),
Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, containing beta glucanes, konjac extract or cinnamon, etc.) or stopped less than 3 months before the V1 visit,
Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit,
With significant change in food habits or in physical activity in the 3 months before the V1 visit or not agreeing to keep them unchanged throughout the study,
With a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the study,
With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded),
Who made a blood donation in the 3 months before the V1 visit or intending to make it within 3 months ahead,
Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros,
Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
Presenting a psychological or linguistic incapability to sign the informed consent,
Impossible to contact in case of emergency,
After V1 biological analysis the subjects will be considered as non eligible to the study on the following criteria:
Fasting blood triglycerides > 4 g/L,
Fasting glycaemia > 1.26 g/L
Blood AST, ALT or GGT > 3xULN (Upper Limit of Normal),
Blood urea > 12.11 mmol/L (value corresponding to 1.5xULN) or creatinine > 125 μmol/L,
Blood hsCRP > 10 mg/L,
Complete blood count with clinically significant abnormality according to the investigator.
Within 3 months following to the exit of the study for failure to comply to one or more of the exclusion criteria listed above, a re-screening could be performed.

Trial locations and contacts

1 site in 1 country.

France1 site

Biofortis Mérieux NutriSciences Clinical Investigation Center
Saint-Herblain, 44800

Other trials in France

About this study

Official title: Pilot Study to Assess Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

Read the detailed description

Main objective

The primary objective of the present trial is to assess the beneficial effect of VAL070-B compared to a placebo, on blood LDL cholesterol level in moderate hypercholesterolemic and hypertriglyceridemic subjects after 12 weeks of consumption.

Secondary objectives

Secondary objectives of the study are to assess the effects of VAL070-A and VAL070-B, compared to a placebo and to each other, in moderate hypercholesterolemic and hypertriglyceridemic subjects after 12 weeks if consumption through the following parameters:

Blood level of LDL cholesterol (VAL070-A compared to placebo and VAL070-A compared to VAL070-B),
Lipid profile: Blood levels of triglycerides, total cholesterol, HDL-cholesterol and non- HDL cholesterol,
Glycaemia,
Blood hsCRP,
Fructosamine,
Blood total free fatty acid levels,
Anthropometrics assessed by body weight (BW), waist circumference (WC), hip circumference (HC) and waist to hip ratio (WHR).

Safety objectives

The following parameters, analyzed at baseline and after 12 weeks of consumption, participated to the safety objectives:

Blood levels of urea and creatinine,
Blood levels of GGT, AST and ALT,
Complete blood count,
Hemodynamic measurements: heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP),
Adverse events.

Conditions: Hypercholesterolemia, Hypertriglyceridemia
Being tested: VAL070-A, VAL070-B, Placebo
Keywords: Prevention
Medical subject headings: Hypercholesterolemia, Hypertriglyceridemia

What participants receive

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

VAL070-ADietary supplement
After randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
VAL070-BDietary supplement
After randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
PlaceboDietary supplement
After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

Study groups in NCT02989753
Study group	Role	What they receive
Placebo	Placebo comparator	The comparative product is a placebo with the same characteristics of appearance and packaging as studied products and in which all ingredients are replaced by maltodextrin. Receives: Dietary Supplement: Placebo
VAL070-A	Experimental	Studied active product n°1, named VAL070-A, is a dietary supplement in shape of capsule. VAL070-A product contains 4 active plant extracts. Receives: Dietary Supplement: VAL070-A
VAL070-B	Experimental	Studied active product n°2, named VAL070-B, is a dietary supplement in shape of capsule. VAL070-B product contains 5 active plant extracts. Receives: Dietary Supplement: VAL070-B

What is being measured

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

Comparison between VAL070-B and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks

Secondary outcomes (22)

Comparison between VAL070-A and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood concentrations of triglycerides
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood concentrations of total cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood concentrations of HDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood concentrations of non-HDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood concentrations of glucose
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
Measured: 12 weeks
Changes in fasting blood concentrations of hsCRP
Defined as the difference V2 (12 weeks) - V1 (baseline) in mg/L
Measured: 12 weeks
Changes in fasting blood concentrations of fructosamine
Defined as the difference V2 (12 weeks) - V1 (baseline) in µmol/L
Measured: 12 weeks
Changes in fasting blood concentrations of total free fatty acid
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmol/L
Measured: 12 weeks
Changes in body weight
Defined as the difference V2 (12 weeks) - V1 (baseline) in kg
Measured: 12 weeks
Changes in waist circumference
Defined as the difference V2 (12 weeks) - V1 (baseline) in cm
Measured: 12 weeks
Changes in hip circumference
Defined as the difference V2 (12 weeks) - V1 (baseline) in cm
Measured: 12 weeks
Changes in waist to hip ratio
Defined as the difference V2 (12 weeks) - V1 (baseline)
Measured: 12 weeks
Changes in fasting blood concentrations of urea
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmol/L
Measured: 12 weeks
Changes in fasting blood concentrations of creatinine
Defined as the difference V2 (12 weeks) - V1 (baseline) in µmol/L
Measured: 12 weeks
Changes in fasting blood concentrations of AST (Aspartate aminotransferase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in µkat/L
Measured: 12 weeks
Changes in fasting blood concentrations of ALT (Alanine aminotransferase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in µkat/L
Measured: 12 weeks
Changes in fasting blood concentrations of GGT (Gamma glutamyltransferase)
Defined as the difference V2 (12 weeks) - V1 (baseline) in µkat/L
Measured: 12 weeks
Changes in complete blood count
Defined as the difference V2 (12 weeks) - V1 (baseline)
Measured: 12 weeks
Changes in heart rate
Defined as the difference V2 (12 weeks) - V1 (baseline) in bpm
Measured: 12 weeks
Changes in systolic blood pressure
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmHg
Measured: 12 weeks
Changes in diastolic blood pressure
Defined as the difference V2 (12 weeks) - V1 (baseline) in mmHg
Measured: 12 weeks

Timeline

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

Jan 2017Jul 2018

First posted12 Dec 2016 (estimated)
Study startJan 2017
Primary completionJun 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypercholesterolemiaStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02989753
Sponsor's protocol ID: 2016-A01178-43
Acronym: Lipiback
Status last verified: May 2017
First submitted: 8 Dec 2016
Last updated: 5 Jul 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study to Assess Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia
ClinicalTrials.gov ID: NCT02989753
Acronym / sponsor ID: Lipiback / 2016-A01178-43
Conditions: Hypercholesterolemia, Hypertriglyceridemia
Keywords: Prevention
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (estimated)
Lead sponsor: ValbiotisIndustry (pharma, biotech, devices)
Collaborators: Biofortis Mérieux NutriSciences
Study start: Jan 2017
Primary completion: Jun 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 12 Dec 2016 (estimated)
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.

Detailed description

Main objective

Secondary objectives

Blood level of LDL cholesterol (VAL070-A compared to placebo and VAL070-A compared to VAL070-B),
Lipid profile: Blood levels of triglycerides, total cholesterol, HDL-cholesterol and non- HDL cholesterol,
Glycaemia,
Blood hsCRP,
Fructosamine,
Blood total free fatty acid levels,
Anthropometrics assessed by body weight (BW), waist circumference (WC), hip circumference (HC) and waist to hip ratio (WHR).

Safety objectives

The following parameters, analyzed at baseline and after 12 weeks of consumption, participated to the safety objectives:

Blood levels of urea and creatinine,
Blood levels of GGT, AST and ALT,
Complete blood count,
Hemodynamic measurements: heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP),
Adverse events.

Study design

Primary purpose: Prevention
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	Dietary Supplement: PlaceboThe comparative product is a placebo with the same characteristics of appearance and packaging as studied products and in which all ingredients are replaced by maltodextrin.
VAL070-A	Experimental	Dietary Supplement: VAL070-AStudied active product n°1, named VAL070-A, is a dietary supplement in shape of capsule. VAL070-A product contains 4 active plant extracts.
VAL070-B	Experimental	Dietary Supplement: VAL070-BStudied active product n°2, named VAL070-B, is a dietary supplement in shape of capsule. VAL070-B product contains 5 active plant extracts.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age between 18 and 70 years (limits included),
BMI between 18.5 and 40 kg/m2 (limits included),
For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel and estrogen/progestin combination contraception accepted) or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded),
Weight stable within ± 5 % in the last three months,
Non smoking or with tobacco consumption < 20 cigarettes / day,

Key exclusion criteria (32 listed)

Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
With a history of ischemic cardiovascular event,
Having undergone recent surgical procedure (less than 6 months),
Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),

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
VAL070-AAfter randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.	Dietary supplement	VAL070-A
VAL070-BAfter randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.	Dietary supplement	VAL070-B
PlaceboAfter randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.	Dietary supplement	Placebo

Primary outcome

Comparison between VAL070-B and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Time frame: 12 weeks
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L

22 secondary outcomes

Comparison between VAL070-A and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Time frame: 12 weeks
Changes in fasting blood concentrations of triglycerides
Time frame: 12 weeks
Changes in fasting blood concentrations of total cholesterol
Time frame: 12 weeks
Changes in fasting blood concentrations of HDL cholesterol
Time frame: 12 weeks
Changes in fasting blood concentrations of non-HDL cholesterol
Time frame: 12 weeks
Changes in fasting blood concentrations of glucose
Time frame: 12 weeks
Changes in fasting blood concentrations of hsCRP
Time frame: 12 weeks
Changes in fasting blood concentrations of fructosamine
Time frame: 12 weeks
Changes in fasting blood concentrations of total free fatty acid
Time frame: 12 weeks
Changes in body weight
Time frame: 12 weeks
Changes in waist circumference
Time frame: 12 weeks
Changes in hip circumference
Time frame: 12 weeks
Changes in waist to hip ratio
Time frame: 12 weeks
Changes in fasting blood concentrations of urea
Time frame: 12 weeks
Changes in fasting blood concentrations of creatinine
Time frame: 12 weeks
Changes in fasting blood concentrations of AST (Aspartate aminotransferase)
Time frame: 12 weeks
Changes in fasting blood concentrations of ALT (Alanine aminotransferase)
Time frame: 12 weeks
Changes in fasting blood concentrations of GGT (Gamma glutamyltransferase)
Time frame: 12 weeks
Changes in complete blood count
Time frame: 12 weeks
Changes in heart rate
Time frame: 12 weeks
Changes in systolic blood pressure
Time frame: 12 weeks
Changes in diastolic blood pressure
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
Individual participant dataSharing planned: Undecided

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David GENDRE, Dr principal investigator

Biofortis Mérieux NutriSciences

Jean-Marie BARD, Dr-PhD study chair

UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France

Sébastien PELTIER, PhD study director

Valbiotis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VAL070-A and VAL070-B in people with Hypercholesterolemia and Hypertriglyceridemia, run by Valbiotis at 1 site in France.

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 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2018. 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 France. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison between VAL070-B and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol (time frame: 12 weeks). 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 NCT02989753.

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 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.