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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2019-06-18

Brief Summary

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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

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Detailed Description

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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

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Diabetes Diabetes Mellitus, Type 2 Cholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bempedoic acid + Ezetimibe FDC

Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule

Group Type EXPERIMENTAL

Bempedoic acid + Ezetimibe FDC Oral Tablet

Intervention Type DRUG

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

Placebo oral capsule

Intervention Type DRUG

Placebo over-encapsulated for blinding purposes

Ezetimibe 10 mg

Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet

Group Type ACTIVE_COMPARATOR

Ezetimibe 10 mg Oral Tablet

Intervention Type DRUG

Ezetimibe 10 mg tablet, overencapsulated for blinding purposes

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablet, matched for the FDC product for blinding purposes

Placebo

Placebo Oral Tablet, Placebo oral capsule

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablet, matched for the FDC product for blinding purposes

Placebo oral capsule

Intervention Type DRUG

Placebo over-encapsulated for blinding purposes

Interventions

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Bempedoic acid + Ezetimibe FDC Oral Tablet

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

Intervention Type DRUG

Ezetimibe 10 mg Oral Tablet

Ezetimibe 10 mg tablet, overencapsulated for blinding purposes

Intervention Type DRUG

Placebo Oral Tablet

Placebo tablet, matched for the FDC product for blinding purposes

Intervention Type DRUG

Placebo oral capsule

Placebo over-encapsulated for blinding purposes

Intervention Type DRUG

Other Intervention Names

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Zetia

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No