DyslipidemiasPhase 2OCEANNCT04770389

Randomized Study of Obicetrapib in Combination With Ezetimibe

A Phase 2 study testing Obicetrapib 5mg and Ezetimibe 10mg in people with Dyslipidemias and High Cholesterol, run by NewAmsterdam Pharma at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Dyslipidemias, High Cholesterol, Hypercholesterolemia
What is being tested?: Obicetrapib 5mg and Ezetimibe 10mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 9 sitesin 2 countries
Study dates: 23 Feb 2021to 30 Jun 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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.

Show all 15Show fewer

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

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

Netherlands6 sites

Huisartsen Praktijk A.M.N. Zijtregto
Rotterdam, 3037 AN
Huisartsen Praktijk van Soerland
Rotterdam, 3067 GJ
Medisch Centrum Thomsonplein
The Hague, 2565 KN
Huisartsen Praktijk Rambharose
The Hague, 2572 GM
Huisartsen Praktijk Broekman
Zwijndrecht, 3333 GZ
Dokters van Nederhoven
Zwijndrecht, 3334 SB

Other trials in Netherlands

United States3 sites

Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201
Juno Research, LLC - Medical Center Office
Houston, Texas, 77054
Clinical Trials Research
Lincoln, California, 95648

Other trials in United States

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized Phase 2 Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe in Participants With Mild Dyslipidemia

Read the 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.

Conditions: Dyslipidemias, High Cholesterol, Hypercholesterolemia
Being tested: Obicetrapib 5mg, Ezetimibe 10mg, Placebo
Keywords: obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Medical subject headings: Dyslipidemias, Hypercholesterolemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Obicetrapib 5mgDrug
Also called CETP inhibitor
tablet
Ezetimibe 10mgDrug
Also called Antihyperlipidemic
tablet
PlaceboOther
tablet

Study groups in NCT04770389
Study group	Role	What they receive
Placebo	Placebo comparator	placebo obicetrapib + placebo ezetimibe; once daily Receives: Other: Placebo
Combination therapy	Experimental	5 mg obicetrapib + 10 mg ezetimibe; once daily Receives: Drug: Obicetrapib 5mg; Drug: Ezetimibe 10mg
Obicetrapib monotherapy	Experimental	5 mg obicetrapib + placebo ezetimibe; once daily Receives: Drug: Obicetrapib 5mg
Ezetimibe monotherapy	Experimental	placebo obicetrapib + 10 mg ezetimibe; once daily Receives: Drug: Ezetimibe 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]
Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]
Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]
Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]
Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks

Secondary outcomes (27)

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]
Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]
Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]
Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]
Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo
Mean percent change in ApoB from baseline to Day 57
Measured: 8 weeks
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo
Median percent change in ApoB from baseline to Day 57
Measured: 8 weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo
LS Mean percent change in ApoB from baseline to Day 57
Measured: 8 weeks
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo
Mean percent change in Apo-B from baseline to Day 57
Measured: 8 weeks
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo
Median percent change in Apo-B from baseline to Day 57
Measured: 8 weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo
LS Mean percent change in Apo-B from baseline to Day 57
Measured: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]
Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]
Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]
Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]
Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula
Measured: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]
Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]
Median percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula
Measured: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]
Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]
Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Measured: 8 weeks
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy
Mean percent change in ApoB from baseline to Day 57
Measured: 8 weeks
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy
Median percent change in ApoB from baseline to Day 57
Measured: 8 weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy
LS Mean Percent change in ApoB from baseline to Day 57
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202130 Jun 2021

First posted25 Feb 2021
Study start23 Feb 2021
Primary completion7 May 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DyslipidemiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Placebo-Controlled, Double-Blind, Randomized
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04770389
Sponsor's protocol ID: TA-8995-303
Acronym: OCEAN
Status last verified: Mar 2024
First submitted: 22 Feb 2021
Last updated: 24 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Pirillo A, Catapano AL. The two faces of cholesteryl ester transfer protein inhibitors. Curr Opin Lipidol. 2025 Dec 1;36(6):318-325. doi: 10.1097/MOL.0000000000001017. Epub 2025 Oct 13.
PubMed 41190670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy

All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-Controlled, Double-Blind, Randomized Phase 2 Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe in Participants With Mild Dyslipidemia
ClinicalTrials.gov ID: NCT04770389
Acronym / sponsor ID: OCEAN / TA-8995-303
Conditions: Dyslipidemias, High Cholesterol, Hypercholesterolemia
Keywords: obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: NewAmsterdam PharmaIndustry (pharma, biotech, devices)
Study start: 23 Feb 2021 (actual)
Primary completion: 7 May 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 25 Feb 2021 (actual)
Results: Posted 24 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Placebo-Controlled, Double-Blind, Randomized

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placeboplacebo obicetrapib + placebo ezetimibe; once daily
Combination therapy	Experimental	Drug: Obicetrapib 5mg, Drug: Ezetimibe 10mg5 mg obicetrapib + 10 mg ezetimibe; once daily
Obicetrapib monotherapy	Experimental	Drug: Obicetrapib 5mg5 mg obicetrapib + placebo ezetimibe; once daily
Ezetimibe monotherapy	Experimental	Drug: Ezetimibe 10mgplacebo obicetrapib + 10 mg ezetimibe; once daily

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Obicetrapib 5mgAlso: CETP inhibitortablet	Drug	Combination therapy, Obicetrapib monotherapy
Ezetimibe 10mgAlso: Antihyperlipidemictablet	Drug	Combination therapy, Ezetimibe monotherapy
Placebotablet	Other	Placebo

Primary outcome

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]
Time frame: 8 weeks
Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]
Time frame: 8 weeks
Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]
Time frame: 8 weeks
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]
Time frame: 8 weeks
Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]
Time frame: 8 weeks
Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]
Time frame: 8 weeks
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

27 secondary outcomes

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]
Time frame: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]
Time frame: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]
Time frame: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]
Time frame: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]
Time frame: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]
Time frame: 8 weeks
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo
Time frame: 8 weeks
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo
Time frame: 8 weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo
Time frame: 8 weeks
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo
Time frame: 8 weeks
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo
Time frame: 8 weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo
Time frame: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]
Time frame: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]
Time frame: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald]
Time frame: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]
Time frame: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]
Time frame: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald]
Time frame: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]
Time frame: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]
Time frame: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald]
Time frame: 8 weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]
Time frame: 8 weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]
Time frame: 8 weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC]
Time frame: 8 weeks
Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy
Time frame: 8 weeks
Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy
Time frame: 8 weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy
Time frame: 8 weeks

Results and safety

Results posted to the registry on 24 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	28	26
Combination Therapy	27	22
Obicetrapib Monotherapy	28	26
Ezetimibe Monotherapy	29	24

Primary outcome: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]

Time frame: 8 weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Combination Therapy n = 24	Placebo n = 27
Value	-45.63 (21.677)	-0.17 (12.682)

Combination Therapy vs Placebo: Least Squares (LS) Mean: -44.92 (95% CI -55.20 to -34.63), p <0.0001, Mixed Models Analysis

Population analysed: The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Primary outcome: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]

Time frame: 8 weeks. Median (Full Range). Unit: percent change from baseline

Measure	Combination Therapy n = 24	Placebo n = 27
Value	-51.95 (-77.9 to 3.1)	-1.40 (-20.9 to 33.6)

Combination Therapy vs Placebo: Least Squares (LS) Mean: -44.92 (95% CI -55.20 to -34.63), p <0.0001, Mixed Models Analysis

Primary outcome: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: percent change from baseline

Measure	Combination Therapy n = 27	Placebo n = 28
Value	-43.55 (3.746)	1.37 (3.604)

Combination Therapy vs Placebo: Least Squares (LS) Mean: -44.92 (95% CI -55.20 to -34.63), p <0.0001, Mixed Models Analysis

Primary outcome: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

Time frame: 8 weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Combination Therapy n = 24	Placebo n = 22
Value	-44.38 (20.731)	-1.53 (15.105)

Combination Therapy vs Placebo: Least Squares (LS) Mean: -43.33 (95% CI -54.29 to -32.36), p <0.0001, ANCOVA

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug through Week 16. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 28 (0%)	6 of 28 (21.4%)	0 of 28
Combination Therapy	0 of 27 (0%)	9 of 27 (33.3%)	0 of 27
Obicetrapib Monotherapy	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28
Ezetimibe Monotherapy	2 of 28 (7.1%)	8 of 28 (28.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41190670Pirillo A, Catapano AL. The two faces of cholesteryl ester transfer protein inhibitors. Curr Opin Lipidol. 2025 Dec 1;36(6):318-325. doi: 10.1097/MOL.0000000000001017. Epub 2025 Oct 13.
Individual participant dataSharing planned: No

Related trials for Dyslipidemias

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obicetrapib 5mg and Ezetimibe 10mg in people with Dyslipidemias and High Cholesterol, run by NewAmsterdam Pharma at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04770389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.