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monotherapy for High Cholesterol (ROSE2 Trial)

Phase 2
Waitlist Available
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights

ROSE2 Trial 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.

Eligible Conditions
  • High Cholesterol
  • Dyslipidemia

ROSE2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of combination therapy compared with placebo on LDL-C
Secondary outcome measures
Effect combination therapy compared with placebo on ApoB
Effect obicetrapib 10 mg monotherapy compared with placebo on ApoB
Effect of obicetrapib 10 mg monotherapy compared with placebo on LDL-C

ROSE2 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: monotherapyExperimental Treatment2 Interventions
once-daily obicetrapib 10 mg tablet and placebo capsule
Group II: combination therapyExperimental Treatment2 Interventions
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
Group III: PlaceboPlacebo Group2 Interventions
once-daily placebo tablet and placebo capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
2022
Completed Phase 2
~440
Ezetimibe 10mg
2017
Completed Phase 4
~10410

Find a Location

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
13,053 Total Patients Enrolled
6 Trials studying High Cholesterol
3,572 Patients Enrolled for High Cholesterol
Marc DitmarschStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
2,940 Total Patients Enrolled
3 Trials studying High Cholesterol
2,940 Patients Enrolled for High Cholesterol

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
2022. "Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05266586.
~39 spots leftby Apr 2025
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