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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia

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