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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- NewAmsterdam Pharma
- Enrollment
- 102
- Locations
- 10
- Primary Endpoint
- Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
placebo tablet made to resemble active product
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Placebo
Once-daily placebo
Intervention: Placebo (Drug)
5 mg Obicetrapib
once-daily Obicetrapib
Intervention: Obicetrapib (Drug)
10 mg Obicetrapib
once-daily Obicetrapib
Intervention: Obicetrapib (Drug)
2.5 mg Obicetrapib
once-daily Obicetrapib
Intervention: Obicetrapib (Drug)
Outcomes
Primary Outcomes
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Time Frame: 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]
Time Frame: 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]
Time Frame: 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]
Time Frame: 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]
Time Frame: 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]
Time Frame: 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 Outcomes
- 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)
- LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)(8 Weeks)
- Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8 weeks)
- Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8 Weeks)
- LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8 Weeks)