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

Sponsor

NewAmsterdam Pharma (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05421078

Collaborator

(none)

108

Enrollment

Locations

Arms

12.1

Anticipated Duration (Months)

10.8

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia Hypercholesterolemia High Cholesterol	Drug: Obicetrapib Drug: Obicetrapib	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Placebo-controlled, double-blind, randomizedPlacebo-controlled, double-blind, randomized

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

placebo tablet made to resemble active product

Primary Purpose:

Treatment

Official Title:

A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects.

Actual Study Start Date :

Jun 27, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Once-daily placebo	Drug: Obicetrapib No active ingredient Other Names: placebo tablet
Experimental: Experimental 2.5 mg Obicetrapib once-daily Obicetrapib	Drug: Obicetrapib tablet Other Names: CETP inhibitor
Experimental: Experimental 5 mg Obicetrapib once-daily Obicetrapib	Drug: Obicetrapib tablet Other Names: CETP inhibitor
Experimental: Experimental 10 mg Obicetrapib once-daily Obicetrapib	Drug: Obicetrapib tablet Other Names: CETP inhibitor

Outcome Measures

Primary Outcome Measures

LDL-C [8 weeks]
percent change in LDL-C

Secondary Outcome Measures

Apo B [8 weeks]
percent change in Apo B
Non-HDL-C [8 weeks]
percent change in Non-HDL-C
HDL-C [8 weeks]
percent change in HDL-C

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Nippon Kokan Fukuyama Hospital	Fukuyama	Japan
2	Nakamura Cardiology and Cardiovascular Surgery Clinic	Itoshima	Japan
3	Kishiwada Tokushu-Kai Hospital	Osaka	Japan
4	Kyosokai AMC NISHI-UMEDA Clinic	Osaka	Japan
5	Sakurabashi Watanabe Hospital	Osaka	Japan
6	Uji Tokushu-Kai Hospital	Osaka	Japan
7	Sanai Hospital	Saitama	Japan
8	Shinden Higashi Clinic	Sendai	Japan
9	Soka-Sugiura Clinic	Soka	Japan
10	Sugiura Clinic	Tokyo	Japan