CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 242 enrolled
Drug / intervention
Bempedoic acid + Ezetimibe FDC Oral Tablet +3 moredrug
Likely dose
Ezetimibe 10 mg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03531905
NCT03531905Phase 2Completed
CompareCT.gov

A Randomized Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 + Ezetimibe 10 Fixed-Dose Combination Compared to Ezetimibe and Placebo In Subjects With T2DM and Elevated LDL-Cholesterol

Esperion Therapeutics, Inc.·interventional·Posted May 22, 2018·Updated Apr 9, 2020

In Brief

A Phase 2 clinical trial evaluating Bempedoic acid + Ezetimibe FDC Oral Tablet, Ezetimibe 10 mg Oral Tablet, and 2 other interventions for Diabetes and 2 related conditions. Completed, enrolled 242 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2, Cholesterolemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 22, 2018
Enrollment StartMay 9, 2018
Primary CompletionJun 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.1 years ago

Interventions

Bempedoic acid + Ezetimibe FDC Oral Tabletdrug

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

Ezetimibe 10 mg Oral Tabletdrug

Ezetimibe 10 mg tablet, overencapsulated for blinding purposes

Placebo Oral Tabletdrug

Placebo tablet, matched for the FDC product for blinding purposes

Placebo oral capsuledrug

Placebo over-encapsulated for blinding purposes