A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2023-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

NCT04753606

Dyslipidemias High Cholesterol Hypercholesterolemia

COMPLETED PHASE2

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

NCT01760460

Dyslipidemia

COMPLETED PHASE3

Randomized Study of Obicetrapib in Combination With Ezetimibe

NCT04770389

Dyslipidemias High Cholesterol Hypercholesterolemia

COMPLETED PHASE2

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

NCT01824238

Heterozygous Familial Hypercholesterolemia (HeFH)

COMPLETED PHASE3

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT05142722

Dyslipidemias High Cholesterol Hypercholesterolemia +2 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up visit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia Hypercholesterolemia High Cholesterol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo-controlled, double-blind, randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

placebo tablet made to resemble active product

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Once-daily placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

No active ingredient

2.5 mg Obicetrapib

once-daily Obicetrapib

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

tablet

5 mg Obicetrapib

once-daily Obicetrapib

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

tablet

10 mg Obicetrapib

once-daily Obicetrapib

Group Type EXPERIMENTAL

Obicetrapib

Intervention Type DRUG

tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Obicetrapib

tablet

Intervention Type DRUG

Placebo

No active ingredient

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CETP inhibitor placebo tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* LDL-C \> 70 mg/dL and TG \< 400 mg/dL,
* Treated with a stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20

Exclusion Criteria

* BMI \> or =35 kg/m2
* Significant cardiovascular disease
* HbA1c \> 10%
* Uncontrolled hypertension
* Active muscle disease
* GFR \< 60 ml/min
* Hepatic dysfunction
* Anemia
* Existing CETP deficiency
* History of Homozygous Familial Hypercholerstrolemia
* History of malignancy
* Alcohol abuse
* Treatment with investigational product
* Treatment with PCSK9
* Clinically significant condition
* Known CETP inhibitor allergy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No