Evanston, Illinois 60201

  • Hypercholesterolemia

Purpose:

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.


Study 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. 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.


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


Study is Available At:


Original ID:

TA-8995-201


NCT ID:

NCT04753606


Secondary ID:


Study Acronym:

ROSE


Brief Title:

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NewAmsterdam Pharma


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Actual


Study Dates

Start Date:February 18, 2021
Completion Date:October 15, 2021
Completion Type:Anticipated
Primary Completion Date:July 2, 2021
Primary Completion Type:Anticipated
Verification Date:March 2021
Last Changed Date:March 29, 2021
First Received Date:February 9, 2021

Study Outcomes

Outcome Type:Secondary Outcome
Measure:HDL-C
Time Frame:8-weeks
Safety Issues:False
Description:Percent change in HDL-C
Outcome Type:Secondary Outcome
Measure:Non-HDL-C
Time Frame:8-weeks
Safety Issues:False
Description:Percent change in Non-HDL-C
Outcome Type:Secondary Outcome
Measure:ApoB
Time Frame:8-weeks
Safety Issues:False
Description:Percent change in ApoB
Outcome Type:Primary Outcome
Measure:LDL-C
Time Frame:8-weeks
Safety Issues:False
Description:Percent change in LDL-C

Study Interventions

Intervention Type:Drug
Name:Obicetrapib
Description:tablets
Arm Name:Placebo
Other Name:CETP inhibitor

Study Arms

Study Arm Type:Experimental
Arm Name:obicetrapib 10 mg
Description:once-daily obicetrapib
Study Arm Type:Experimental
Arm Name:obicetrapib 5 mg
Description:once-daily obicetrapib
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:once-daily placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:NewAmsterdam Pharma

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.