Trials / Completed
CompletedNCT03531905
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Esperion Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients with type 2 diabetes and elevated LDL-C.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-05-09
- Primary completion
- 2019-06-18
- Completion
- 2019-06-18
- First posted
- 2018-05-22
- Last updated
- 2020-04-09
- Results posted
- 2020-04-09
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03531905. Inclusion in this directory is not an endorsement.