Clinical trial NCT05421078: A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Hypercholesterolemia
High Cholesterol
Keywords: obicetrapib
statin
LDL-C cholestero
l atherosclerosis
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled, double-blind, randomized
Primary purpose: TREATMENT

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 stable statin therapy.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
timeFrame: 8 Weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
timeFrame: 8 Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
timeFrame: 8 Weeks
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
timeFrame: 8 Weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
timeFrame: 8 Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
timeFrame: 8 Weeks
Secondary outcomes:
measure: Mean Percent Change in Apolipoprotein B (ApoB)
timeFrame: 8 Weeks
measure: Median Percent Change in Apolipoprotein B (ApoB)
timeFrame: 8 Weeks
measure: LS Mean Percent Change in Apolipoprotein B (ApoB)
timeFrame: 8 Weeks
measure: Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 8 weeks
measure: Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 8 Weeks
measure: LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 8 Weeks
measure: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 8 weeks
measure: Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 8 Weeks
measure: LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Fukuyama
country: Japan
facility: Nippon Kokan Fukuyama Hospital
city: Itoshima
country: Japan
facility: Nakamura Cardiology and Cardiovascular Surgery Clinic
city: Osaka
country: Japan
facility: Kishiwada Tokushu-Kai Hospital
city: Osaka
country: Japan
facility: Kyosokai AMC NISHI-UMEDA Clinic
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Osaka
country: Japan
facility: Uji Tokushu-Kai Hospital
city: Saitama
country: Japan
facility: Sanai Hospital
city: Sendai
country: Japan
facility: Shinden Higashi Clinic
city: Soka
country: Japan
facility: Soka-Sugiura Clinic
city: Tokyo
country: Japan
facility: Sugiura Clinic
Study officials:
affiliation: NewAmsterdam Pharma
name: Marc Ditmarsch, MD
role: STUDY_DIRECTOR
References: