Actively Recruiting
A Phase III Study of Bempedoic Acid Tablets to Evaluate Efficacy, Tolerability, and Safety in Patients with Primary Hyperlipidemia Not Adequately Controlled by Statins
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-01-17
240
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well Bempedoic Acid Tablets work, how tolerable they are, and their safety in treating adults with primary hyperlipidemia whose condition is not adequately controlled by statins. The study is a phase III clinical trial focusing on this specific patient group to understand the effects of this treatment better. Participants will receive either Bempedoic Acid Tablets or a placebo, both taken once daily by mouth. The study compares these two groups to assess the medication's impact on lowering LDL cholesterol levels. The treatment period lasts 12 weeks. During the study, researchers will monitor participants' LDL cholesterol levels at the start and at week 12 to measure changes. Participants will be carefully observed for side effects and overall safety. The total participation time includes the treatment period and necessary follow-up assessments to ensure accurate results and safety monitoring.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older, male or female.
- Body Mass Index (BMI) between 18 kg/m2 and 35 kg/m2.
- Agreement to use reliable contraception from screening until 30 days after last dose and no donation of sperm or eggs for assisted reproduction.
- Ability to understand study purpose and requirements, voluntary participation, and signing informed consent, with capability to complete the study.
You will not qualify if you...
- Allergy to any component of the investigational drug or history of allergic diseases such as asthma, urticaria, or eczema.
- Fasting triglycerides levels equal or above 5.64 mmol/L (500 mg/dL) at screening.
- History of malignant tumors before screening.
- History of substance abuse including drugs, alcohol, or amphetamines.
- Participation in other clinical trials or use of investigational drugs/devices within 3 months or 5 half-lives of drugs before screening.
- Pregnant or breastfeeding females or positive pregnancy test.
- Any other conditions deemed unsuitable by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Site 01
Beijing, China
Actively Recruiting
Research Team
W
Wei Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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