Actively Recruiting
Phase III Clinical Study to Evaluate Bempedoic Acid's Efficacy, Tolerability, and Safety in Patients with Hyperlipidemia Not Controlled by Statins
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-01-17
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase III clinical trial to study the effects of Bempedoic Acid Tablets in adults with primary hyperlipidemia whose condition is not adequately controlled by statins. The study aims to assess the drug's effectiveness, tolerability, and safety in this patient group. It is sponsored by Gan & Lee Pharmaceuticals and involves a randomized, double-blind design to compare treatments. Participants will be randomly assigned to receive either the Bempedoic Acid Tablet or a placebo, both administered once daily by mouth. The treatment period focuses on a 12-week timeframe to evaluate changes in cholesterol levels. The study includes assessments of LDL-C and total cholesterol levels as key measures, alongside monitoring for any adverse events throughout the trial. During the study, participants will undergo evaluations at baseline and at week 12 to measure cholesterol changes. Safety will be monitored through reports of adverse and serious adverse events up to week 13. The trial requires informed consent and adherence to contraception guidelines for participants of reproductive potential. The total participation length spans at least 13 weeks, including treatment and safety follow-up.
CONDITIONS
Brief 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.
- Agree to use reliable contraception from screening until 30 days after the last dose and not donate sperm or eggs for assisted reproduction.
- Understand the study purpose, voluntarily participate, and sign informed consent.
- Capable of completing the entire study process.
You will not qualify if you...
- Known allergy to the investigational drug or its components, or history of allergic diseases like asthma, urticaria, or eczema.
- Fasting triglycerides equal to or greater than 5.64 mmol/L (500 mg/dL) at screening.
- History of malignant tumors before screening.
- History of drug, alcohol, amphetamine, or other substance abuse.
- Participation in other clinical studies or use of investigational drugs/devices within 3 months prior to screening or within 5 half-lives of the drugs.
- Pregnant or breastfeeding females, or positive pregnancy test.
- Any other factors making the participant unsuitable according to the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive either Bempedoic Acid or a placebo once daily to evaluate efficacy, tolerability, and safety.
1 baseline visit and 1 follow-up visit
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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