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Completed

NCT Number: NCT04753606

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

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 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

Pinnacle Research Group, Anniston, Alabama, United States

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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 high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 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 and a 15-week PK 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 TG < 400 mg/dL,
  • Treated with a high-intensity statin therapy

Exclusion criteria

  • BMI > 40 kg/m
  • Significant cardiovascular disease
  • HbA1c > 10%
  • Uncontrolled hypertension
  • Active muscle disease
  • GFR < 60 ml/min
  • Hepatic dysfunction
  • 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

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. [Friedewald] 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 Iin 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. [Friedewald] 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

    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 level was measured directly 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-Week

    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 High-Intensity Statin Therapy

Acronym: ROSE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Jul 12, 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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