MedTrace Logo

Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C

NCT03531905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-04-09

Study results available
· View outcomes & findings →

Summary

12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Cholesterolemia

Interventions

DRUG

Bempedoic acid + Ezetimibe FDC Oral Tablet

Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet

DRUG

Ezetimibe 10 mg Oral Tablet

Ezetimibe 10 mg tablet, overencapsulated for blinding purposes

DRUG

Placebo Oral Tablet

Placebo tablet, matched for the FDC product for blinding purposes

DRUG

Placebo oral capsule

Placebo over-encapsulated for blinding purposes

Sponsors & Collaborators

  • Esperion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Haberman, MD · Esperion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2019-06-18
Completion
2019-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531905 on ClinicalTrials.gov