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Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy (ROSE2)

Primary Purpose

Dyslipidemias, High Cholesterol, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obicetrapib
Ezetimibe 10mg
Obicetrapib placebo
Ezetimibe placebo
Sponsored by
NewAmsterdam Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring obicetrapib, statin, LDL-C, cholesterol, atherosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL,
  • Treated with a high-intensity statin therapy

Exclusion Criteria:

  • BMI >= 40 kg/m2
  • Significant cardiovascular disease
  • HbA1c >= 10%
  • Uncontrolled hypertension
  • Active muscle disease
  • estimated glomerular filtration rate < 60 mL/min
  • Hepatic dysfunction
  • History of participation in any clinical trial evaluating obicetrapib
  • Anemia
  • History of malignancy
  • Alcohol abuse
  • Treatment with investigational product
  • Treatment with PCSK9
  • Clinically significant condition
  • Known CETP inhibitor allergy

Sites / Locations

  • Velocity Clinical Research - Westlake d.b.a National Research Institute
  • Valley Clinical Trials, Inc.
  • Ocala Cardiovascular Research
  • A & R Research Group, LLC
  • Progressive Medical Research
  • Meridian Clinical Research - Savannah, GA
  • Velocity Clinical Research
  • Biofortis, Inc
  • Northwest Heart Clinical Research, LLC
  • Midwest Institute for Clinical Research
  • Research Integrity LLC
  • Oakland Medical Research Center
  • Mercury Street Medical
  • Meridian Clinical Research- Springdale, OH
  • Aventiv Research, Inc.
  • Summit Research Group, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

monotherapy

combination therapy

Arm Description

once-daily placebo tablet and placebo capsule

once-daily obicetrapib 10 mg tablet and placebo capsule

once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

Outcomes

Primary Outcome Measures

Effect of combination therapy compared with placebo on LDL-C
Percent change in LDL-C

Secondary Outcome Measures

Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C
Percent change in LDL-C
Effect combination therapy compared with placebo on ApoB
Percent change in ApoB
Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB
Percent change in ApoB

Full Information

First Posted
February 23, 2022
Last Updated
October 7, 2022
Sponsor
NewAmsterdam Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05266586
Brief Title
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Acronym
ROSE2
Official Title
A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewAmsterdam Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.
Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, High Cholesterol, Hypercholesterolemia
Keywords
obicetrapib, statin, LDL-C, cholesterol, atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled, double-blind, randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
placebo tablet made to resemble active; placebo capsule made to resemble active
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once-daily placebo tablet and placebo capsule
Arm Title
monotherapy
Arm Type
Experimental
Arm Description
once-daily obicetrapib 10 mg tablet and placebo capsule
Arm Title
combination therapy
Arm Type
Experimental
Arm Description
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
Intervention Type
Drug
Intervention Name(s)
Obicetrapib
Other Intervention Name(s)
CETP inhibitor
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
Ezetimibe 10mg
Intervention Description
capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
Intervention Type
Other
Intervention Name(s)
Obicetrapib placebo
Intervention Description
tablets; no active ingredient
Intervention Type
Other
Intervention Name(s)
Ezetimibe placebo
Intervention Description
capsules; no active ingredient
Primary Outcome Measure Information:
Title
Effect of combination therapy compared with placebo on LDL-C
Description
Percent change in LDL-C
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C
Description
Percent change in LDL-C
Time Frame
12-weeks
Title
Effect combination therapy compared with placebo on ApoB
Description
Percent change in ApoB
Time Frame
12-weeks
Title
Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB
Description
Percent change in ApoB
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL, Treated with a high-intensity statin therapy Exclusion Criteria: BMI >= 40 kg/m2 Significant cardiovascular disease HbA1c >= 10% Uncontrolled hypertension Active muscle disease estimated glomerular filtration rate < 60 mL/min Hepatic dysfunction History of participation in any clinical trial evaluating obicetrapib Anemia History of malignancy Alcohol abuse Treatment with investigational product Treatment with PCSK9 Clinically significant condition Known CETP inhibitor allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ditmarsch
Organizational Affiliation
NewAmsterdam Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research - Westlake d.b.a National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Ocala Cardiovascular Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
A & R Research Group, LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Meridian Clinical Research - Savannah, GA
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Velocity Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Biofortis, Inc
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Northwest Heart Clinical Research, LLC
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Integrity LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Meridian Clinical Research- Springdale, OH
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Summit Research Group, LLC
City
Munroe Falls
State/Province
Ohio
ZIP/Postal Code
44240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

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