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NCT05421078 Clinical Trial

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Hypercholesterolemia Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05421078
Other study ID # TA-8995-203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 27, 2022
Est. completion date August 23, 2023

Study information
Verified date July 2023
Source NewAmsterdam Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date August 23, 2023
Est. primary completion date April 21, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Obicetrapib
tablet
• Obicetrapib
No active ingredient

Locations
Country Name City State
Japan Nippon Kokan Fukuyama Hospital Fukuyama
Japan Nakamura Cardiology and Cardiovascular Surgery Clinic Itoshima
Japan Kishiwada Tokushu-Kai Hospital Osaka
Japan Kyosokai AMC NISHI-UMEDA Clinic Osaka
Japan Sakurabashi Watanabe Hospital Osaka
Japan Uji Tokushu-Kai Hospital Osaka
Japan Sanai Hospital Saitama
Japan Shinden Higashi Clinic Sendai
Japan Soka-Sugiura Clinic Soka
Japan Sugiura Clinic Tokyo

Sponsors (1)
Lead Sponsor Collaborator
NewAmsterdam Pharma

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary LDL-C percent change in LDL-C 8 weeks
Secondary Apo B percent change in Apo B 8 weeks
Secondary Non-HDL-C percent change in Non-HDL-C 8 weeks
Secondary HDL-C percent change in HDL-C 8 weeks
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