Status:
COMPLETED
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Dyslipidemias
High Cholesterol
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 a...
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 a...
Eligibility Criteria
Inclusion
- LDL-C \> 70 mg/dL and Triglycerides \< 400 mg/dL,
- Treated with a high-intensity statin therapy
Exclusion
- 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
- Anemia
- History of malignancy
- Alcohol abuse
- Treatment with investigational product
- Treatment with PCSK9
- Clinically significant condition
- Known CETP inhibitor allergy
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05266586
Start Date
March 9 2022
End Date
September 8 2022
Last Update
July 3 2024
Active Locations (16)
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1
Velocity Clinical Research - Westlake d.b.a National Research Institute
Los Angeles, California, United States, 90057
2
Valley Clinical Trials, Inc.
Northridge, California, United States, 91325
3
Ocala Cardiovascular Research
Ocala, Florida, United States, 34471
4
A & R Research Group, LLC
Pembroke Pines, Florida, United States, 33024