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

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: Dyslipidemia; Hypercholesterolemia; High Cholesterol
• Intervention / Treatment: Drug: Placebo; Drug: Obicetrapib

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): 102
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).	8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).	8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).	8 Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).	8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)	8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Apolipoprotein B (ApoB)	Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8 Weeks
Median Percent Change in Apolipoprotein B (ApoB)	Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8 Weeks
LS Mean Percent Change in Apolipoprotein B (ApoB)	Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8 Weeks
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8 weeks
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8 Weeks
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8 Weeks
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8 weeks
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8 Weeks
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.	8 Weeks

Collaborators and Investigators

• Sponsor: NewAmsterdam Pharma
• Investigators: Study Director: Marc Ditmarsch, MD, NewAmsterdam Pharma

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): April 21, 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): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: statin; obicetrapib; LDL-C cholestero; l atherosclerosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Dyslipidemias
• 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