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

Primary Purpose

Dyslipidemia, Hypercholesterolemia, High Cholesterol

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Obicetrapib
Obicetrapib
Sponsored by
NewAmsterdam Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring obicetrapib, statin, LDL-C cholestero, l atherosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nippon Kokan Fukuyama Hospital
  • Nakamura Cardiology and Cardiovascular Surgery Clinic
  • Kishiwada Tokushu-Kai Hospital
  • Kyosokai AMC NISHI-UMEDA Clinic
  • Sakurabashi Watanabe Hospital
  • Uji Tokushu-Kai Hospital
  • Sanai Hospital
  • Shinden Higashi Clinic
  • Soka-Sugiura Clinic
  • Sugiura Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Experimental 2.5 mg Obicetrapib

Experimental 5 mg Obicetrapib

Experimental 10 mg Obicetrapib

Arm Description

Once-daily placebo

once-daily Obicetrapib

once-daily Obicetrapib

once-daily Obicetrapib

Outcomes

Primary Outcome Measures

LDL-C
percent change in LDL-C

Secondary Outcome Measures

Apo B
percent change in Apo B
Non-HDL-C
percent change in Non-HDL-C
HDL-C
percent change in HDL-C

Full Information

First Posted
June 13, 2022
Last Updated
September 5, 2023
Sponsor
NewAmsterdam Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05421078
Brief Title
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
August 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewAmsterdam Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Hypercholesterolemia, High Cholesterol
Keywords
obicetrapib, statin, LDL-C cholestero, l atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled, double-blind, randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
placebo tablet made to resemble active product
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once-daily placebo
Arm Title
Experimental 2.5 mg Obicetrapib
Arm Type
Experimental
Arm Description
once-daily Obicetrapib
Arm Title
Experimental 5 mg Obicetrapib
Arm Type
Experimental
Arm Description
once-daily Obicetrapib
Arm Title
Experimental 10 mg Obicetrapib
Arm Type
Experimental
Arm Description
once-daily Obicetrapib
Intervention Type
Drug
Intervention Name(s)
Obicetrapib
Other Intervention Name(s)
CETP inhibitor
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Obicetrapib
Other Intervention Name(s)
placebo tablet
Intervention Description
No active ingredient
Primary Outcome Measure Information:
Title
LDL-C
Description
percent change in LDL-C
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Apo B
Description
percent change in Apo B
Time Frame
8 weeks
Title
Non-HDL-C
Description
percent change in Non-HDL-C
Time Frame
8 weeks
Title
HDL-C
Description
percent change in HDL-C
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ditmarsch, MD
Organizational Affiliation
NewAmsterdam Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Nippon Kokan Fukuyama Hospital
City
Fukuyama
Country
Japan
Facility Name
Nakamura Cardiology and Cardiovascular Surgery Clinic
City
Itoshima
Country
Japan
Facility Name
Kishiwada Tokushu-Kai Hospital
City
Osaka
Country
Japan
Facility Name
Kyosokai AMC NISHI-UMEDA Clinic
City
Osaka
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
Country
Japan
Facility Name
Uji Tokushu-Kai Hospital
City
Osaka
Country
Japan
Facility Name
Sanai Hospital
City
Saitama
Country
Japan
Facility Name
Shinden Higashi Clinic
City
Sendai
Country
Japan
Facility Name
Soka-Sugiura Clinic
City
Soka
Country
Japan
Facility Name
Sugiura Clinic
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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