Actively Recruiting
A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
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 trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Site 01
Beijing, China
Actively Recruiting
Research Team
W
Wei Zhao
CONTACT
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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