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

NCT03531905 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1002FDC-058
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

diabetes; cholesterolemia; type 2 diabetes; LDL-C; T2D; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)

  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 Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. Percent change from Baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline value\]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.

  Baseline; Week 12

Secondary Outcomes (11)

• Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo)

  Baseline; Week 12

• Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)

  Baseline; Week 12

• Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

  Baseline; Week 12

• Percent Change From Baseline to Week 12 in Total Cholesterol (TC)

  Baseline; Week 12

• Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)

  Baseline; Week 12

Other Outcomes (4)

• Percent Change From Baseline to Week 12 in Fasting Plasma Glucose

  Baseline; Week 12

• Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG)

  Baseline; Week 12

• Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index

  Baseline; Week 12

Study Arms (3)

Bempedoic acid + Ezetimibe FDC

EXPERIMENTAL

Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule

Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet; Drug: Placebo oral capsule

Ezetimibe 10 mg

ACTIVE COMPARATOR

Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet

Drug: Ezetimibe 10 mg Oral Tablet; Drug: Placebo Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo Oral Tablet, Placebo oral capsule

Drug: Placebo Oral Tablet; Drug: Placebo oral capsule

Interventions

Bempedoic acid + Ezetimibe FDC Oral Tablet DRUG

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

Bempedoic acid + Ezetimibe FDC

Ezetimibe 10 mg Oral Tablet DRUG

Ezetimibe 10 mg tablet, overencapsulated for blinding purposes

Also known as: Zetia

Ezetimibe 10 mg

Placebo Oral Tablet DRUG

Placebo tablet, matched for the FDC product for blinding purposes

Ezetimibe 10 mg; Placebo

Placebo oral capsule DRUG

Placebo over-encapsulated for blinding purposes

Bempedoic acid + Ezetimibe FDC; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes for 6 months or greater
• Currently taking stable diabetes medication for 3 months or greater
• HbA1c between 7-10%
• LDL-cholesterol greater than 70 mg/dL
• Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication

You may not qualify if:

• Body mass index \> 40 kg/m2
• History of documented clinically significant cardiovascular disease
• Fasting triglycerides \> 400 mg/dL
• History of Type 1 diabetes
• Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy
• History of drug or alcohol abuse within 2 years

Sponsors & Collaborators

• Esperion Therapeutics, Inc.: lead

Study Sites (4)

Clinical Trials Research

Lincoln, California, 95648, United States

Location

FInlay Medical Research

Miami, Florida, 33126, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Hampton Roads Center for Clinical Research

Suffolk, Virginia, 23435, United States

Location

Related Publications (1)

• Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.

  PMID: 24385236 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe; Tablets

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Sites 5801003, 5801041, and 5801043 were suspected of Good Clinical Practice violations in an earlier Phase 3 trial (NCT03337308), hence the Efficacy Analysis Set (which excluded these 3 sites) was designated as the primary efficacy analysis set.

Results Point of Contact

• Title: Medical Director
• Organization: Esperion Therapeutics, Inc.

medinfo@esperion.com

1-833-377-7633

Study Officials

• Ron Haberman, MD

  Esperion Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 22, 2018
• Study Start: May 9, 2018
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: April 9, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)