Health TrialsbyHealthPanel

A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid

ConditionPrimary Hyperlipidemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGan & Lee Pharmaceuticals.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. 18 years and older, male or female.

2. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2.

3. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes.

4. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process.

Disqualifiers

1. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution.

2. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening.

3. History of malignant tumors prior to screening.

4. History of drug, alcohol, amphetamines, or other drug abuse.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bempedoic Acid Tablet

    Drug

    Once daily, oral

  • Placebo

    Drug

    Once daily, oral

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Bempedoic acidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change from baseline in LDL-C levels at Week 12

Time frame
Baseline, Week 12

Secondary outcomes

1

Percentage change from baseline in total cholesterol (TC) levels at Week 12

Time frame
Baseline, Week 12
2

Adverse events (AEs) and serious adverse events (SAEs) during the study

Time frame
Baseline, Week 13

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gan & Lee Pharmaceuticals.

Lead sponsor

Source ClinicalTrials.gov
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