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Completed

NCT Number: NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.

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Key information

Conditions

Dyslipidemias Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases High Cholesterol Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Velocity Clinical Research - Westlake d.b.a National Research Institute, Los Angeles, California, United States

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About this study

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

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 Triglycerides < 400 mg/dL,
  • Treated with a high-intensity statin therapy

Exclusion criteria

  • BMI >= 40 kg/m2
  • Significant cardiovascular disease
  • HbA1c >= 10%
  • Uncontrolled hypertension
  • Active muscle disease
  • estimated glomerular filtration rate < 60 mL/min
  • Hepatic dysfunction
  • History of participation in any clinical trial evaluating obicetrapib
  • Anemia
  • 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

tablets

Other names: CETP inhibitor

Ezetimibe 10mg

Drug

capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

Obicetrapib Placebo

Other

tablets; no active ingredient

Ezetimibe Placebo

Other

capsules; no active ingredient

Primary outcomes

  1. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

    Time frame: 12-weeks

    Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

    Time frame: 12-Weeks

    Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

    Time frame: 12-Weeks

    LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [PUC]

    Time frame: 12-Weeks

    Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  5. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

    Time frame: 12-Weeks

    Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  6. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

    Time frame: 12-Weeks

    LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Secondary outcomes

  1. Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

    Time frame: 12-weeks

    Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

    Time frame: 12-Weeks

    Median percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

    Time frame: 12-Weeks

    LS Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with 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) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

    Time frame: 12-Weeks

    Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  5. Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

    Time frame: 12-Weeks

    Median percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  6. LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

    Time frame: 12-Weeks

    LS Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  7. Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo

    Time frame: 12-weeks

    Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group

  8. Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo

    Time frame: 12-Weeks

    Median percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group

  9. LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo

    Time frame: 12-Weeks

    LS Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group

  10. Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo

    Time frame: 12-weeks

    Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group

  11. Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo

    Time frame: 12-Weeks

    Median percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group

  12. LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo

    Time frame: 12-Weeks

    LS Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment 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 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study

Acronym: ROSE2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Jul 3, 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.

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