Obicetrapib for High Cholesterol

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
High Cholesterol+4 MoreObicetrapib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether obicetrapib is effective and safe in people with familial hypercholesterolemia or ASCVD.

Eligible Conditions
  • High Cholesterol
  • Dyslipidemia
  • Atherosclerotic Cardiovascular Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

0 Primary · 9 Secondary · Reporting Duration: Percent change from baseline to Day 84, Day 180, and Day 365 in TC

Baseline to Day 400
Cardiovascular hospitalizations
Major adverse cardiac event (MACE)
Day 395
major adverse cardiac event (MACE)
Day 84
Apolipoprotein A1 (ApoA1)
Day 84
Lipoprotein A [Lp(a)]
Day 365
apolipoprotein B (ApoB)
Day 365
HDL-C
Day 365
Total Cholesterol
Day 365
Triglycerides
Day 365
non-HDL-C
Day 180
LDL-C

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

obicetrapib 10mg
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

2400 Total Participants · 2 Treatment Groups

Primary Treatment: Obicetrapib · Has Placebo Group · Phase 3

obicetrapib 10mg
Drug
Experimental Group · 1 Intervention: Obicetrapib · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: percent change from baseline to day 84, day 180, and day 365 in tc

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
7 Previous Clinical Trials
9,772 Total Patients Enrolled
5 Trials studying High Cholesterol
759 Patients Enrolled for High Cholesterol
Marc DitmarschStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
527 Total Patients Enrolled
3 Trials studying High Cholesterol
527 Patients Enrolled for High Cholesterol

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are not breastfeeding.\n
You have HeFH and/or a history of established ASCVD.
You have taken ezetimibe for at least 4 weeks prior to the screening test.

Who else is applying?

What state do they live in?
Illinois66.7%
Arizona33.3%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%
What site did they apply to?
Biofortis, Inc100.0%
Why did patients apply to this trial?
  • "I have elevated Lipoprotein (a) with slightly elevated LDL. Total chol approx 180. A heart CT several months ago showed Calcium buildup in my LAD. Was since prescribed two different statins.. Had Angiogram (and Stent placement) last week in LAD showing 99 percent blockage in LAD. Interested in something that might lower my Lipoprotein (a) instead of raising it which the stains apparently do"
How many prior treatments have patients received?
150.0%
3+50.0%