Health TrialsbyHealthPanel

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

ConditionPrimary Hyperlipidemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Ouyi Pharmaceutical Co., Ltd.

About this trial

This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy 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

For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);

For participants with extremely high risk of ASCVD: LDL-C≥ 1.8 mmol/L (or 70 mg/dL); 3) For participants with ultra-high risk of ASCVD: LDL-C≥ 1.4 mmol/L (or 55 mg/dL).

Disqualifiers

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

Diagnosis with HoFH.

History of tendon diseases or tendon ruptures before the screening.

Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bempedoic Acid Tablet

    Drug

    bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

  • Placebo

    Drug

    Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: Bempedoic Acid TabletExperimental 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

Proportion of participants achieving LDL-C target

Time frame
Baseline, Week 12
2

Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12

Time frame
Baseline, Week 12
3

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

Time frame
Baseline, Week 13

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

CSPC Ouyi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: