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ROSE2: Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Sponsor
NewAmsterdam Pharma (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05266586
Collaborator
(none)
119
Enrollment
7
Locations
3
Arms
5.8
Anticipated Duration (Months)
17
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Obicetrapib
  • Drug: Ezetimibe 10mg
  • Other: Obicetrapib placebo
  • Other: Ezetimibe placebo
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Placebo-controlled, double-blind, randomizedPlacebo-controlled, double-blind, randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
placebo tablet made to resemble active; placebo capsule made to resemble active
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Aug 4, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

once-daily placebo tablet and placebo capsule

Other: Obicetrapib placebo
tablets; no active ingredient

Other: Ezetimibe placebo
capsules; no active ingredient
Experimental: monotherapy

once-daily obicetrapib 10 mg tablet and placebo capsule

Drug: Obicetrapib
tablets
Other Names:
  • CETP inhibitor

    • Other: Ezetimibe placebo
    capsules; no active ingredient
    Experimental: combination therapy

    once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

    Drug: Obicetrapib
    tablets
    Other Names:
  • CETP inhibitor

    • Drug: Ezetimibe 10mg
    capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

    Outcome Measures

    Primary Outcome Measures

    1. Effect of combination therapy compared with placebo on LDL-C [12-weeks]

      Percent change in LDL-C

    Secondary Outcome Measures

    1. Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C [12-weeks]

      Percent change in LDL-C

    2. Effect combination therapy compared with placebo on ApoB [12-weeks]

      Percent change in ApoB

    3. Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB [12-weeks]

      Percent change in ApoB

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Velocity Clinical Research Gardena California United States 90247
    2 Velocity Clinical Research - Westlake d.b.a National Research Institute Los Angeles California United States 90057
    3 A & R Research Group, LLC Pembroke Pines Florida United States 33024
    4 Velocity Clinical Research Meridian Idaho United States 83642
    5 Biofortis, Inc Addison Illinois United States 60101
    6 Northwest Heart Clinical Research, LLC Arlington Heights Illinois United States 60005
    7 Summit Research Group, LLC Munroe Falls Ohio United States 44240

    Sponsors and Collaborators

    • NewAmsterdam Pharma

    Investigators

    • Study Director: Marc Ditmarsch, NewAmsterdam Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NewAmsterdam Pharma
    ClinicalTrials.gov Identifier:
    NCT05266586
    Other Study ID Numbers:
    • TA-8995-202
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NewAmsterdam Pharma
    obicetrapib
    statin
    LDL-C
    cholesterol
    atherosclerosis
    Additional relevant MeSH terms:
    Hypercholesterolemia
    Dyslipidemias
    Ezetimibe

    Study Results

    No Results Posted as of Jul 15, 2022