Excellence Medical Research
Miami Gardens, Florida, 33169, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06982508
Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers
The goal of this clinical trial is to learn if Obicetrapib works to change antioxidant levels in HDL and plasma, as well as retinal tissue. The main questions it aims to answer are:
Do Obicetrapib effect absorption of antioxidants in a person's blood or their eye tissue? Researchers will compare Obicetrapib to a placebo (a look-alike substance that contains no drug) to see if Obicetrapib helps improve a person's ability to absorb antioxidants.
Participants will:
Take Obicetrapib or a placebo every day for 4 months Visit the clinic once every 8 weeks for checkups and tests Have their blood taken and their eyes checked to measure antioxidant levels
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Visual acuity > 20/60 in both eyes with or without corrective lenses
Exclusion criteria
- Type 2 diabetes
- Active liver disease
- Any clinically significant macular pathology
Treatment and study plan
Obicetrapib 10mg
DrugActive Drug
Placebo
DrugPlacebo Control
Primary outcomes
-
Sum of Percent Change of Antioxidant Levels within HDL
Time frame: 16 Weeks
The primary efficacy endpoint is the effect of obicetrapib on the sum of the percent changes in lutein, zeaxanthin, and α-tocopherol levels within HDL particles from baseline to visit 4 (week 16) compared to placebo.
Secondary outcomes
-
Effects of Obicetrapib on Percent Changes of Antioxidant Levels in Retinal Tissue, Plasma, and HDL Particles
Time frame: 8 and 16 weeks
The secondary efficacy endpoints are the effect of obicetrapib compared to placebo on the percent changes from baseline to visit 3 (week 8) and baseline to visit 4 (week 16) for the following variables:
- MPOD
- Plasma level of α-tocopherol
- Plasma level of lutein
- Plasma level of zeaxanthin
- Lutein within HDL particles
- Zeaxanthin within HDL particles
- α-tocopherol within HDL particles
- Sum of the percent changes in lutein, zeaxanthin, and α-tocopherol in plasma
- Sum of the percent changes in lutein, zeaxanthin, and α-tocopherol within HDL particles from baseline to visit 3 (week 8)
- LDL-C
- HDL-C
- Non-HDL-C
- ApoA1
- ApoB
- Lp(a)
- TC
- TG
Sponsors and collaborators
Lead sponsor
NewAmsterdam Pharma
Industry
Collaborators
- MB Clinical Research and Consulting LLC
Registry information
Official study title
A Randomized, Double-Blind, Placebo-Controlled Parallel Trial to Assess the Effects of Obicetrapib on Levels of Antioxidants in Plasma and HDL Particles in Healthy Volunteers: The VERMEER Study
Acronym: VERMEER
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 21, 2025
- Registry last updated
- Oct 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.