- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05266586
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy (ROSE2)
October 7, 2022 updated by: NewAmsterdam Pharma
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90057
- Velocity Clinical Research - Westlake d.b.a National Research Institute
-
Northridge, California, United States, 91325
- Valley Clinical Trials, Inc.
-
-
Florida
-
Ocala, Florida, United States, 34471
- Ocala Cardiovascular Research
-
Pembroke Pines, Florida, United States, 33024
- A & R Research Group, LLC
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Port Orange, Florida, United States, 32127
- Progressive Medical Research
-
-
Georgia
-
Savannah, Georgia, United States, 31406
- Meridian Clinical Research - Savannah, GA
-
-
Idaho
-
Meridian, Idaho, United States, 83642
- Velocity Clinical Research
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis, Inc
-
Arlington Heights, Illinois, United States, 60005
- Northwest Heart Clinical Research, LLC
-
-
Indiana
-
Indianapolis, Indiana, United States, 46260
- Midwest Institute for Clinical Research
-
-
Kentucky
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Owensboro, Kentucky, United States, 42303
- Research Integrity LLC
-
-
Michigan
-
Troy, Michigan, United States, 48085
- Oakland Medical Research Center
-
-
Montana
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Butte, Montana, United States, 59701
- Mercury Street Medical
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-
Ohio
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Cincinnati, Ohio, United States, 45219
- Meridian Clinical Research- Springdale, OH
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Columbus, Ohio, United States, 43213
- Aventiv Research, Inc.
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Munroe Falls, Ohio, United States, 44240
- Summit Research Group, LLC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
once-daily placebo tablet and placebo capsule
|
tablets; no active ingredient
capsules; no active ingredient
|
Experimental: monotherapy
once-daily obicetrapib 10 mg tablet and placebo capsule
|
tablets
Other Names:
capsules; no active ingredient
|
Experimental: combination therapy
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
|
tablets
Other Names:
capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of combination therapy compared with placebo on LDL-C
Time Frame: 12-weeks
|
Percent change in LDL-C
|
12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C
Time Frame: 12-weeks
|
Percent change in LDL-C
|
12-weeks
|
Effect combination therapy compared with placebo on ApoB
Time Frame: 12-weeks
|
Percent change in ApoB
|
12-weeks
|
Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB
Time Frame: 12-weeks
|
Percent change in ApoB
|
12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2022
Primary Completion (Actual)
August 12, 2022
Study Completion (Actual)
September 8, 2022
Study Registration Dates
First Submitted
February 23, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 4, 2022
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA-8995-202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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