Status:
COMPLETED
Randomized Study of Obicetrapib as an Adjunct to Statin 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 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin t...
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 high-intensity statin t...
Eligibility Criteria
Inclusion
- LDL-C \> 70 mg/dL and TG \< 400 mg/dL,
- Treated with a high-intensity statin therapy
Exclusion
- BMI \> 40 kg/m
- Significant cardiovascular disease
- HbA1c \> 10%
- Uncontrolled hypertension
- Active muscle disease
- GFR \< 60 ml/min
- Hepatic dysfunction
- 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 :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04753606
Start Date
February 18 2021
End Date
August 30 2021
Last Update
July 12 2024
Active Locations (19)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
National Research Institute - Huntington Park
Huntington Park, California, United States, 90255
3
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
4
Clinical Trials Research
Sacramento, California, United States, 95821