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

Phase 2

Completed

• Conditions: Dyslipidemia; Hypercholesterolemia; High Cholesterol
• Interventions: Drug: Placebo; Drug: Obicetrapib

• Registration Number: NCT05421078
• Lead Sponsor: NewAmsterdam Pharma

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.

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Study Start: 2022-06-27
• Primary Completion: 2023-03-24
• Study Completion: 2023-04-21
• Status Verified: 2024-09
• Results First Submitted: 2024-09-03
• Results First Submitted QC: 2024-09-03
• Results First Posted: 2024-09-27
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Once-daily placebo
2.5 mg Obicetrapib	Obicetrapib	once-daily Obicetrapib
5 mg Obicetrapib	Obicetrapib	once-daily Obicetrapib
10 mg Obicetrapib	Obicetrapib	once-daily Obicetrapib

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	8 Weeks	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).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	8 Weeks	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).
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]	8 Weeks	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).
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	8 Weeks	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).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	8 Weeks	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)
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]	8 Weeks	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).

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Nippon Kokan Fukuyama Hospital; 🇯🇵 Fukuyama, Japan

Kishiwada Tokushu-Kai Hospital; 🇯🇵 Osaka, Japan

Nakamura Cardiology and Cardiovascular Surgery Clinic; 🇯🇵 Itoshima, Japan

Kyosokai AMC NISHI-UMEDA Clinic; 🇯🇵 Osaka, Japan

Sugiura Clinic; 🇯🇵 Tokyo, Japan

Shinden Higashi Clinic; 🇯🇵 Sendai, Japan

Uji Tokushu-Kai Hospital; 🇯🇵 Osaka, Japan

Soka-Sugiura Clinic; 🇯🇵 Soka, Japan

Sanai Hospital; 🇯🇵 Saitama, Japan

Sakurabashi Watanabe Hospital; 🇯🇵 Osaka, Japan