Skip to main content
OpenTrials
Completed

NCT Number: NCT05421078

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias High Cholesterol Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nippon Kokan Fukuyama Hospital, Fukuyama, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obicetrapib

Drug

tablet

Other names: CETP inhibitor

Placebo

Drug

No active ingredient

Other names: placebo tablet

Primary outcomes

  1. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

    Time frame: 8 Weeks

    Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  2. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

    Time frame: 8 Weeks

    Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  3. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

    Time frame: 8 Weeks

    LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  4. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

    Time frame: 8 Weeks

    Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  5. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

    Time frame: 8 Weeks

    Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)

  6. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

    Time frame: 8 Weeks

    Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Secondary outcomes

  1. Mean Percent Change in Apolipoprotein B (ApoB)

    Time frame: 8 Weeks

    Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

  2. Median Percent Change in Apolipoprotein B (ApoB)

    Time frame: 8 Weeks

    Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

  3. LS Mean Percent Change in Apolipoprotein B (ApoB)

    Time frame: 8 Weeks

    Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.

  4. Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: 8 weeks

    Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

  5. Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: 8 Weeks

    Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

  6. LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: 8 Weeks

    LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

  7. Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: 8 weeks

    Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

  8. Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: 8 Weeks

    Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group

  9. LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: 8 Weeks

    LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2022
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.