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

September 5, 2023 updated by: NewAmsterdam Pharma

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

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 Contact

Study Locations

  • Japan
      • Fukuyama, Japan
        • Nippon Kokan Fukuyama Hospital
      • Itoshima, Japan
        • Nakamura Cardiology and Cardiovascular Surgery Clinic
      • Osaka, Japan
        • Kyosokai Amc Nishi-Umeda Clinic
      • Osaka, Japan
        • Sakurabashi Watanabe Hospital
      • Osaka, Japan
        • Kishiwada Tokushu-Kai Hospital
      • Osaka, Japan
        • Uji Tokushu-Kai Hospital
      • Saitama, Japan
        • Sanai Hospital
      • Sendai, Japan
        • Shinden Higashi Clinic
      • Soka, Japan
        • Soka-Sugiura Clinic
      • Tokyo, Japan
        • Sugiura Clinic

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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
Once-daily placebo
Drug: Obicetrapib
tablet
Other Names:
  • CETP inhibitor
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
Drug: Obicetrapib
No active ingredient
Other Names:
  • placebo tablet
Experimental: Experimental 5 mg Obicetrapib
once-daily Obicetrapib
Drug: Obicetrapib
tablet
Other Names:
  • CETP inhibitor
Drug: Obicetrapib
No active ingredient
Other Names:
  • placebo tablet
Experimental: Experimental 10 mg Obicetrapib
once-daily Obicetrapib
Drug: Obicetrapib
tablet
Other Names:
  • CETP inhibitor
Drug: Obicetrapib
No active ingredient
Other Names:
  • placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-C
Time Frame: 8 weeks
percent change in LDL-C
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apo B
Time Frame: 8 weeks
percent change in Apo B
8 weeks
Non-HDL-C
Time Frame: 8 weeks
percent change in Non-HDL-C
8 weeks
HDL-C
Time Frame: 8 weeks
percent change in HDL-C
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NewAmsterdam Pharma

Investigators

  • Study Director: Marc Ditmarsch, MD, NewAmsterdam Pharma

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)

June 27, 2022

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

August 23, 2023

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-8995-203

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

product manufactured in and exported from the U.S.

Yes

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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