Status:
COMPLETED
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Dyslipidemia
Hypercholesterolemia
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 in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to st...
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 i...
Eligibility Criteria
Inclusion
- LDL-C \> 70 mg/dL and TG \< 400 mg/dL,
- Treated with a stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20
Exclusion
- 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
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05421078
Start Date
June 27 2022
End Date
April 21 2023
Last Update
October 29 2024
Active Locations (10)
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1
Nippon Kokan Fukuyama Hospital
Fukuyama, Japan
2
Nakamura Cardiology and Cardiovascular Surgery Clinic
Itoshima, Japan
3
Kishiwada Tokushu-Kai Hospital
Osaka, Japan
4
Kyosokai AMC NISHI-UMEDA Clinic
Osaka, Japan