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NCT03531905 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Esperion Therapeutics.

Completed
Registry status
Phase 2
Development phase
242
Enrollment target

NCT03531905: Completed Phase 2 study, sponsored by Esperion Therapeutics.

NCT03531905 is a Phase 2 study that has completed, run by Esperion Therapeutics. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03531905, a Phase 2 study, has completed, sponsored by Esperion Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
242 participants
Enrollment target

Study 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

Primary Outcome

Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseli

Interventions

  • DRUG Placebo oral capsule
  • DRUG Placebo Oral Tablet
  • DRUG Bempedoic acid + Ezetimibe FDC Oral Tablet
  • DRUG Ezetimibe 10 mg Oral Tablet

Trial Details

FieldValue
Enrollment Target 242 participants
Start Date 2018-05-09
Est. Completion 2019-06-18
Phase Phase 2
Esperion Therapeutics

23 total trials

What the finished NCT03531905 record still lists

NCT03531905 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo oral capsule is the first listed.

NCT03531905 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03531905 about?

NCT03531905 is a clinical study titled "Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C". 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

What is the current status of trial NCT03531905?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2018-05-09. Estimated completion is 2019-06-18.

What interventions are being tested in trial NCT03531905?

The interventions under investigation include: Placebo oral capsule (DRUG), Placebo Oral Tablet (DRUG), Bempedoic acid + Ezetimibe FDC Oral Tablet (DRUG), Ezetimibe 10 mg Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT03531905?

This trial is sponsored by Esperion Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03531905's enrollment target sits among peer trials

242 237th of 2000 higher than 1,762 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03531905, the US trial registry maintained by the National Library of Medicine. NCT03531905 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.