CLINICAL TRIALS PROFILE FOR APABETALONE

Clinical Trials for Apabetalone

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00768274 ↗	Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol	Completed	Resverlogix Corp	Phase 1/Phase 2	The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
NCT01058018 ↗	Clinical Trial for Dose Finding and Safety of RVX000222 in Subjects With Stable Coronary Artery Disease	Completed	Resverlogix Corp	Phase 2	The purpose of this study is to investigate dose range, safety and efficacy of RVX000222 in subjects with stable coronary artery disease.
NCT02586155 ↗	Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD	Completed	ICON plc	Phase 3	The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.
NCT02586155 ↗	Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD	Completed	Medidata Solutions	Phase 3	The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.
NCT02586155 ↗	Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD	Completed	PPD	Phase 3	The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.
NCT02586155 ↗	Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD	Completed	Resverlogix Corp	Phase 3	The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major adverse cardiovascular events.
NCT03160430 ↗	A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis	Unknown status	Resverlogix Corp	Phase 1/Phase 2	This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care. Part B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC. The primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.

Clinical Trial Conditions for Apabetalone

Condition Name

Condition Name for
Intervention	Trials
Pulmonary Arterial Hypertension	2
Atherosclerosis	2
Coronary Artery Disease	2
Kidney Failure, Chronic	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Hypertension	2
Cardiovascular Diseases	2
Familial Primary Pulmonary Hypertension	2
Atherosclerosis	2

Clinical Trial Locations for Apabetalone

Trials by Country

Trials by Country for
Location	Trials
Canada	6
United States	3
Poland	1
Israel	1
Croatia	1

Trials by US State

Trials by US State for
Location	Trials
California	2
Texas	1

Clinical Trial Progress for Apabetalone

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	3
Unknown status	2
Not yet recruiting	1

Clinical Trial Sponsors for Apabetalone

Sponsor Name

Sponsor Name for
Sponsor	Trials
Resverlogix Corp	8
ICON plc	1
Medidata Solutions	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	11
Other	3