A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients with Dyslipidemia - A3309 in Dyslipidemia
- Conditions
- Patients with dyslipidemia but otherwise without symptoms/signs of diseaseMedDRA version: 12.1Level: LLTClassification code 10058110Term: Dyslipidemia
- Registration Number
- EUCTR2009-017878-21-SE
- Lead Sponsor
- Albireo AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Dyslipidemia as measured by Total cholesterol evaluation and evaluation of other lipid parameter
Male or non-pregnant females aged 18 to 80 years inclusive, with body mass index (BMI) 18.5 to 35 inclusive;
Loose stools not present more often than once a month;
Female subjects of childbearing potential, must have a negative serum pregnancy test at the Screening Visit (Clinic Visit 1);
The patient agrees to refrain from making any new, major life-style changes that may affect the metabolism (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last study visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of IMP
Known cardiovascular disease or manifestation of atherosclerosis
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV)
S-Cholesterol >8.5 mmol/L
S-Triglycerides > 4 mmol/L
Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Any clinically significant findings on a Screening physical examination or 12 lead ECG
Known or suspected history of drug or alcohol abuse as judged by the investigator
Positive screen for alcohol and/or drugs of abuse at screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary efficacy objective of this Phase IIa study is to assess the efficacy of two dose levels of multiple doses of A3309 in patients with dyslipidemia;Secondary Objective: Secondary objectives of this study include assessment of the safety and tolerability of two dose levels of multiple doses of A3309 in patients with dyslipidemia;Primary end point(s): Change from baseline in Total cholesterol and LDL cholesterol
- Secondary Outcome Measures
Name Time Method