Status:
UNKNOWN
Effects of Arterin Cholesterol for Reduction of Lipid Levels
Lead Sponsor:
Perrigo CSCI
Collaborating Sponsors:
Analyze & Realize
Conditions:
Blood Cholesterol Lowers
LDL-C
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The main objective of this double-blind, randomised, placebo-controlled study is to assess the benefit and tolerability of Arterin Cholesterol in subjects with elevated lipid levels within a 12-week p...
Eligibility Criteria
Inclusion
- Males and females
- 18 to 65 years old
- BMI 25 - 29.9 kg/m2
- Generally in good health
- LDL-C level between 3.359-4.884 mmol/L (130-189 mg/dL)
- Stable body weight for at least 3 months prior to study inclusion (\<3 kg weight change) (self-reported)
- Not smoking, at least 6 months prior to study inclusion and throughout the study
- Electrocardiogram (ECG) without pathological findings at V1
- Readiness and ability to comply with study requirements, in particular:
- to take IP as recommended
- to avoid the use of any nutritional, medical and further interventional options for reduction/maintenance of lipid levels during the study (other than the IP)
- to avoid consumption of grapefruit, but otherwise keep the dietary habits
- to keep the habitual level of physical activity during the study
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- Readiness not to participate in another clinical study during this study
Exclusion
- Known allergy or hypersensitivity to the components of the investigational product
- LDL-C level ≥4.910 mmol/L (≥190 mg/dL)
- Total cholesterol level ≥7.254 mmol/L (≥280 mg/dL)
- Triglyceride level ≥2.851 mmol/L (≥250 mg/dL)
- HDL-C level \<1.034 mmol/L (\<40 mg/dL)
- Known genetic hyperlipidemia
- Known family history of dyslipidemia
- History and/or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- cardiovascular disease/disorder (myocardial infarction, angina pectoris, stroke, heart failure, arrhythmia) within 6 months or requiring percutaneous coronary intervention or coronary artery bypass surgery
- untreated or non-stabilised thyroid gland disorder
- untreated or non-stabilised hypertension (regular systolic blood pressure
- ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- untreated/non-stabilised diabetes mellitus type 1 or 2
- acute or chronic psychotic disorder
- any other relevant serious diseases
- Deviation of safety laboratory parameter(s) at V1 that is:
- clinically significant or
- \>2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- Regular medication and/or supplementation and/or treatment (including any natural health products) within the last 2 months prior to V1 and during the study, as per investigator judgement:
- lipid lowering products (known to affect lipid metabolism, platelet function, antioxidant status, etc.), including dietary or health supplements (e.g. omega-3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, soy protein, psyllium seed husk, probiotics/prebiotics)
- products that can influence cholesterol levels (e.g. corticosteroids, beta blockers, amiodarone, estrogen, anabolic steroids), unless it is long term and stabilised (contraceptives are allowed in case of a stable continuous intake before and during the study)
- that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.)
- any other, which could interfere with the results of the study or the safety of the subject
- Women of childbearing potential: pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Participation in another study during the last 30 days prior to V1
- Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04749784
Start Date
October 30 2020
End Date
June 1 2021
Last Update
February 11 2021
Active Locations (1)
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1
analyze & realize GmbH
Berlin, Germany, 13467