- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04770389
Randomized Study of Obicetrapib in Combination With Ezetimibe (OCEAN)
July 8, 2021 updated by: NewAmsterdam Pharma
A Placebo-Controlled, Double-Blind, Randomized Phase 2 Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe in Participants With Mild Dyslipidemia
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
The screening period for this study will take up to 2 weeks.
Following the screening period, eligible patients will be randomized to placebo, 5 mg obicetrapib + 10 mg ezetimibe; 5 mg obicetrapib + placebo ezetimibe; or placebo obicetrapib + 10 mg ezetimibe for an 8 week treatment period.
After the treatment period, patients will continue for a 4 week safety follow-up and a 8 week PK follow-up.
Study Type
Interventional
Enrollment (Actual)
112
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
-
-
-
Den Haag, Netherlands, 2565 KN
- Medisch Centrum Thomsonplein
-
Den Haag, Netherlands, 2572 GM
- Huisartsen Praktijk Rambharose
-
Rotterdam, Netherlands, 3037 AN
- Huisartsen Praktijk A.M.N. Zijtregto
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Rotterdam, Netherlands, 3067 GJ
- Huisartsen Praktijk van Soerland
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Zwijndrecht, Netherlands, 3333 GZ
- Huisartsen Praktijk Broekman
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Zwijndrecht, Netherlands, 3334 SB
- Dokters van Nederhoven
-
-
-
-
California
-
Lincoln, California, United States, 95648
- Clinical Trials Research
-
-
Illinois
-
Evanston, Illinois, United States, 60201
- Evanston Premier Healthcare Research LLC
-
-
Texas
-
Houston, Texas, United States, 77054
- Juno Research, LLC - Medical Center Office
-
-
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
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Understanding of the study procedures, willingness to adhere to the study schedules and diet, and agreement to participate in the study by giving written informed consent prior to Screening procedures
- Men or women 18 to 70 years of age, inclusive
- Women may be enrolled if all 3 of the following criteria are met:
- They are not pregnant;
- They are not breastfeeding; and
- They do not plan on becoming pregnant during the study
- Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit.
- Women of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit. Men whose partners are of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit.
- Fasting LDL-C levels >2.5 mmol/L (>100 mg/dL) and <4.5 mmol/L (<175 mg/dL) and TG levels <4.5 mmol/L (<400 mg/dL) (Visit 1) and
- Willingness to maintain a stable diet and physical activity level throughout the study
Exclusion Criteria:
- Body mass index >= 40 kg/m2
- Participation in another clinical study involving an investigational or marketed drug within 30 days prior to the Screening Visit
- Currently taking any lipid-altering therapy
- Any clinical manifestation of atherosclerotic CVD or any evidence of ischemic coronary disease present on the 12-lead ECG at the Screening Visit
- Diagnosis of type 1 or type 2 diabetes mellitus; or HbA1c >= 6.5% at the Screening visit if no prior diagnosis of diabetes mellitus
- Uncontrolled hypertension ie, sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >90 mmHg taken as the average of triplicate measurements.
One retest will be allowed, at which point if the retest result is no longer exclusionary, the participant may be randomized
- Active muscle disease or persistent creatine kinase concentration >3 x the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result, at which point if the retest result is no longer exclusionary, the participant may be randomized
- History of torsades de pointes
- Estimated glomerular filtration rate <60 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
- Hepatic dysfunction as evidenced by any laboratory abnormality as follows: gamma- glutamyl transferase, alanine aminotransferase, or aspartate aminotransferase >2 x ULN, or total bilirubin >1.5 x ULN
- Anemia, defined as hemoglobin concentration <11 g/dL for males and hemoglobin concentration <9 g/dL for females
- History of malignancy within the past 5 years, with the exception of non-melanoma skin cancers
- Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study
- Known ezetimibe or CETP inhibitor allergy or intolerance
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
placebo obicetrapib + placebo ezetimibe; once daily
|
tablet
|
Experimental: Combination therapy
5 mg obicetrapib + 10 mg ezetimibe; once daily
|
tablet
Other Names:
tablet
Other Names:
|
Experimental: Obicetrapib monotherapy
5 mg obicetrapib + placebo ezetimibe; once daily
|
tablet
Other Names:
|
Experimental: Ezetimibe monotherapy
placebo obicetrapib + 10 mg ezetimibe; once daily
|
tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
obicetrapib in combination with ezetimibe compared to placebo on LDL-C
Time Frame: 8 weeks
|
Percent change from baseline in LDL-C
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
obicetrapib monotherapy compared to placebo on LDL-C
Time Frame: 8 weeks
|
Percent change from baseline in LDL-C
|
8 weeks
|
obicetrapib in combination with ezetimibe compared to placebo on ApoB
Time Frame: 8 weeks
|
Percent change from baseline in ApoB
|
8 weeks
|
obicetrapib monotherapy compared to placebo on Apo-B
Time Frame: 8 weeks
|
Percent change from baseline in Apo-B
|
8 weeks
|
obicetrapib in combination with ezetimibe compared to ezetimibe monotherapy on LDL-C
Time Frame: 8 weeks
|
Percent change from baseline in LDL-C
|
8 weeks
|
obicetrapib monotherapy compared to ezetimibe monotherapy on LDL-C
Time Frame: 8 weeks
|
Percent change from baseline in LDL-C
|
8 weeks
|
ezetimibe monotherapy compared to placebo on LDL-C
Time Frame: 8 weeks
|
Percent change from baseline in LDL-C
|
8 weeks
|
obicetrapib in combination with ezetimibe compared to ezetimibe monotherapy on ApoB
Time Frame: 8 weeks
|
Percent change from baseline in ApoB
|
8 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)
February 23, 2021
Primary Completion (Actual)
May 7, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
February 22, 2021
First Posted (Actual)
February 25, 2021
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA-8995-303
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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