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

Sponsor
Gan & Lee Pharmaceuticals.
Study ID
NCT06780410
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Primary Hyperlipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Jan 2025
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bempedoic acid
    Once daily
  • Placebo Comparator: Placebo
    Once daily

Primary Outcome Measure

Percentage change from baseline in LDL-C levels at Week 12 [ Time Frame: Baseline, Week 12 ]

Central Contacts