A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study
Overview
- Phase
- Phase 2
- Intervention
- Obicetrapib placebo
- Conditions
- Dyslipidemias
- Sponsor
- NewAmsterdam Pharma
- Enrollment
- 119
- Locations
- 16
- Primary Endpoint
- Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.
Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •LDL-C \> 70 mg/dL and Triglycerides \< 400 mg/dL,
- •Treated with a high-intensity statin therapy
Exclusion Criteria
- •BMI \>= 40 kg/m2
- •Significant cardiovascular disease
- •HbA1c \>= 10%
- •Uncontrolled hypertension
- •Active muscle disease
- •estimated glomerular filtration rate \< 60 mL/min
- •Hepatic dysfunction
- •History of participation in any clinical trial evaluating obicetrapib
- •History of malignancy
- •Alcohol abuse
Arms & Interventions
Placebo
once-daily placebo tablet and placebo capsule
Intervention: Obicetrapib placebo
Placebo
once-daily placebo tablet and placebo capsule
Intervention: Ezetimibe placebo
monotherapy
once-daily obicetrapib 10 mg tablet and placebo capsule
Intervention: Obicetrapib
monotherapy
once-daily obicetrapib 10 mg tablet and placebo capsule
Intervention: Ezetimibe placebo
combination therapy
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
Intervention: Obicetrapib
combination therapy
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
Intervention: Ezetimibe 10mg
Outcomes
Primary Outcomes
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
Time Frame: 12-Weeks
Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
Time Frame: 12-Weeks
LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [PUC]
Time Frame: 12-Weeks
LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
Time Frame: 12-weeks
Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [PUC]
Time Frame: 12-Weeks
Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
Time Frame: 12-Weeks
Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Secondary Outcomes
- Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC](12-Weeks)
- Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC](12-Weeks)
- LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo(12-Weeks)
- Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald](12-Weeks)
- Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo(12-Weeks)
- Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo(12-weeks)
- Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo(12-Weeks)
- Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo(12-weeks)
- Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald](12-weeks)
- LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald](12-Weeks)
- LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC](12-Weeks)
- LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo(12-Weeks)