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Randomized Study of Obicetrapib as an Adjunct to Statin Therapy (ROSE)

Primary Purpose

Dyslipidemias, High Cholesterol, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obicetrapib
Sponsored by
NewAmsterdam Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring obicetrapib, statin, LDL-C, cholesterol, atherosclerosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group
  • National Research Institute - Huntington Park
  • National Research Institute - Wilshire
  • Clinical Trials Research
  • Jacksonville Center for Clinical Research
  • Ocala Cardiovascular Research
  • Progressive Medical Research
  • IACT Health
  • Evanston Premier Healthcare Research LLC
  • Midwest Institute for Clinical Research
  • Oakland Medical Research Center
  • Diabetes and Endocrinology Consultants, P.C.
  • Lillestol Research, LLC
  • Metabolic and Atherosclerosis Research Center
  • Summit Research Group, LLC
  • Monument Health Clinical Research
  • Health Concepts
  • Juno Research, LL
  • Manassas Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

obicetrapib 5 mg

obicetrapib 10 mg

Arm Description

once-daily placebo

once-daily obicetrapib

once-daily obicetrapib

Outcomes

Primary Outcome Measures

LDL-C
Percent change in LDL-C

Secondary Outcome Measures

ApoB
Percent change in ApoB
Non-HDL-C
Percent change in Non-HDL-C
HDL-C
Percent change in HDL-C

Full Information

First Posted
February 9, 2021
Last Updated
September 3, 2021
Sponsor
NewAmsterdam Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04753606
Brief Title
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Acronym
ROSE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewAmsterdam Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, High Cholesterol, Hypercholesterolemia
Keywords
obicetrapib, statin, LDL-C, cholesterol, atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled, double-blind, randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
placebo tablet made to resemble active
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once-daily placebo
Arm Title
obicetrapib 5 mg
Arm Type
Experimental
Arm Description
once-daily obicetrapib
Arm Title
obicetrapib 10 mg
Arm Type
Experimental
Arm Description
once-daily obicetrapib
Intervention Type
Drug
Intervention Name(s)
Obicetrapib
Other Intervention Name(s)
CETP inhibitor
Intervention Description
tablets
Primary Outcome Measure Information:
Title
LDL-C
Description
Percent change in LDL-C
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
ApoB
Description
Percent change in ApoB
Time Frame
8-weeks
Title
Non-HDL-C
Description
Percent change in Non-HDL-C
Time Frame
8-weeks
Title
HDL-C
Description
Percent change in HDL-C
Time Frame
8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Clinical Trials Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Ocala Cardiovascular Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Diabetes and Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lillestol Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Metabolic and Atherosclerosis Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Summit Research Group, LLC
City
Munroe Falls
State/Province
Ohio
ZIP/Postal Code
44262
Country
United States
Facility Name
Monument Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Juno Research, LL
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35953719
Citation
Nicholls SJ, Ditmarsch M, Kastelein JJ, Rigby SP, Kling D, Curcio DL, Alp NJ, Davidson MH. Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nat Med. 2022 Aug;28(8):1672-1678. doi: 10.1038/s41591-022-01936-7. Epub 2022 Aug 11.
Results Reference
derived

Learn more about this trial

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

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