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

NCT05421078 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TA-8995-203
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 10

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.

Conditions

Dyslipidemia; Hypercholesterolemia; High Cholesterol

Keywords

obicetrapib; statin; LDL-C cholestero; l atherosclerosis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Mean Percent Change in Apolipoprotein B (ApoB)

  8 Weeks

• Median Percent Change in Apolipoprotein B (ApoB)

  8 Weeks

• LS Mean Percent Change in Apolipoprotein B (ApoB)

  8 Weeks

• Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

  8 weeks

• Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

  8 Weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Once-daily placebo

Drug: Placebo

2.5 mg Obicetrapib

EXPERIMENTAL

once-daily Obicetrapib

Drug: Obicetrapib

5 mg Obicetrapib

EXPERIMENTAL

once-daily Obicetrapib

Drug: Obicetrapib

10 mg Obicetrapib

EXPERIMENTAL

once-daily Obicetrapib

Drug: Obicetrapib

Interventions

Obicetrapib DRUG

tablet

Also known as: CETP inhibitor

10 mg Obicetrapib; 2.5 mg Obicetrapib; 5 mg Obicetrapib

Placebo DRUG

No active ingredient

Also known as: placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (10)

Nippon Kokan Fukuyama Hospital

Fukuyama, Japan

Location

Nakamura Cardiology and Cardiovascular Surgery Clinic

Itoshima, Japan

Location

Kishiwada Tokushu-Kai Hospital

Osaka, Japan

Location

Kyosokai AMC NISHI-UMEDA Clinic

Osaka, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, Japan

Location

Uji Tokushu-Kai Hospital

Osaka, Japan

Location

Sanai Hospital

Saitama, Japan

Location

Shinden Higashi Clinic

Sendai, Japan

Location

Soka-Sugiura Clinic

Sōka, Japan

Location

Sugiura Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Results Point of Contact

• Title: Study Director
• Organization: NewAmsterdam Pharma

study.director@newamsterdampharma.com

+1(305) 627-3081

Study Officials

• Marc Ditmarsch, MD

  NewAmsterdam Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo tablet made to resemble active product
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, double-blind, randomized

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 27, 2022
• Primary Completion: March 24, 2023
• Study Completion: April 21, 2023
• Last Updated: October 29, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)