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Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06982508
Acronym
VERMEER
Enrollment
100
Registered
2025-05-21
Start date
2025-09-09
Completion date
2026-12-31
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antioxidant Absorption

Keywords

Healthy Volunteer

Brief summary

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

Interventions

Active Drug

DRUGPlacebo

Placebo Control

Sponsors

MB Clinical Research and Consulting LLC
CollaboratorUNKNOWN
NewAmsterdam Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sum of Percent Change of Antioxidant Levels within HDL16 WeeksThe 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

MeasureTime frameDescription
Effects of Obicetrapib on Percent Changes of Antioxidant Levels in Retinal Tissue, Plasma, and HDL Particles8 and 16 weeksThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026