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

NCT06780410 | Recruiting Phase 3

• 1 other identifier: BDP-HLD-301
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary Hyperlipidemia

Keywords

Bempedoic Acid; Hyperlipidemia; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Week 12

Secondary Outcomes (2)

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

  Baseline, Week 12

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

  Baseline, Week 13

Study Arms (2)

Bempedoic acid

EXPERIMENTAL

Once daily

Drug: Bempedoic Acid Tablet

Placebo

PLACEBO COMPARATOR

Once daily

Drug: Placebo

Interventions

Bempedoic Acid Tablet DRUG

Once daily, oral

Bempedoic acid

Placebo DRUG

Once daily, oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18 years and older, male or female.
• \. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2.
• \. 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening.
• \. History of malignant tumors prior to screening.
• \. History of drug, alcohol, amphetamines, or other drug abuse.
• \. Participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer).
• \. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test.
• \. Any other factors that the investigator believes makes the participant unsuitable for the study.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Site 01

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Wei Zhao

CONTACT

010-56456726; wei.zhao@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: December 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

CN (1)