100 Participants Needed

Obicetrapib for Antioxidant Deficiency

(VERMEER Trial)

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: NewAmsterdam Pharma
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Obicetrapib, a new potential drug, can boost antioxidant levels in the blood and eye tissues. Antioxidants protect cells from damage. Participants will take either Obicetrapib or a placebo daily for four months, with clinic visits every eight weeks for checkups and tests. The trial suits individuals with clear vision (better than 20/60 with or without glasses) and no major eye problems, but not those with type 2 diabetes or liver disease. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Obicetrapib is likely to be safe for humans?

Research has shown that Obicetrapib has been tested in people to assess its safety and effectiveness. In previous studies, researchers compared Obicetrapib to a placebo to identify any unwanted effects. The results indicated that Obicetrapib was generally well-tolerated, with no significant increase in major side effects compared to the placebo.

One study found that Obicetrapib even helped lower the risk of serious heart problems, suggesting its safety. Another study examined individuals with a type of heart disease and found that Obicetrapib did not cause any major health issues over a year.

Since Obicetrapib is undergoing a phase 2 trial, it has already passed initial safety checks. If it were unsafe, it would not have reached this stage. Thus far, Obicetrapib appears safe for human use, though ongoing trials like this one are crucial to confirm this.12345

Why do researchers think this study treatment might be promising?

Obicetrapib is unique because it targets antioxidant deficiency by potentially enhancing the body's natural ability to manage oxidative stress. Unlike standard treatments that primarily focus on supplementing antioxidants directly, Obicetrapib works by modulating lipid metabolism, which may indirectly boost antioxidant capacity. Researchers are excited about this treatment because it represents a novel approach with the potential to improve cellular resilience against oxidative damage more effectively than conventional antioxidant supplements.

What evidence suggests that Obicetrapib might be an effective treatment for antioxidant deficiency?

Research has shown that Obicetrapib can significantly increase antioxidant levels in the blood. One study found that it boosts antioxidants like lutein, zeaxanthin, and α-tocopherol within HDL particles, which are part of good cholesterol. Another study suggested that it raises antioxidant levels in both the blood and HDL, while lowering them in non-HDL. This indicates that Obicetrapib might help the body absorb more antioxidants overall. These findings suggest that Obicetrapib could effectively enhance antioxidant levels. Participants in this trial will receive either Obicetrapib or a placebo to further evaluate its effectiveness.13467

Are You a Good Fit for This Trial?

This trial is for healthy volunteers with visual acuity better than 20/60 in both eyes, which can be natural or corrected with lenses. It's designed to assess if Obicetrapib affects antioxidant levels in blood and eye tissue.

Inclusion Criteria

I can see clearly from 20 feet what should normally be seen at 60 feet with both eyes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Obicetrapib or a placebo every day for 4 months

16 weeks
2 visits (in-person) every 8 weeks for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Obicetrapib
Trial Overview The study tests whether taking Obicetrapib (10mg) daily over four months changes antioxidant absorption compared to a placebo. Participants will have regular clinic visits every eight weeks for checkups, blood tests, and eye examinations.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Obicetrapib 10mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NewAmsterdam Pharma

Lead Sponsor

Trials
17
Recruited
13,900+

MB Clinical Research and Consulting LLC

Collaborator

Trials
3
Recruited
360+

Citations

Effect of obicetrapib, a potent cholesteryl ester transfer ...Obicetrapib significantly slowed AD biomarker progression over 12 months in participants with ASCVD, with the greatest effects in ApoE4 carriers ...
Evaluation of Obicetrapib on Antioxidant Levels in Plasma ...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 ...
Impact of Obicetrapib on Major Adverse Cardiovascular ...Obicetrapib produced greater reductions in LDL-C (−34.0 vs −4.0 mg/dL, −37.8% vs −4.6%), ApoB (−19.0 vs −3.0 mg/dL, −21.7% vs −3.6%), non-HDL-C (−36.0 vs −4.0 ...
Cholesteryl ester transfer protein inhibition: a pathway to ...Several Phase III trials of obicetrapib are in progress, including the Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in ...
The Effect of Obicetrapib on Lipophilic AntioxidantsObicetrapib significantly increases plasma and HDL levels of antioxidants, robustly increasing all antioxidant levels in HDL and decreasing them in non-HDL.
Efficacy and safety of obicetrapib in patients with dyslipidemiaTherefore, we conducted a systematic review and meta-analysis of RCTs comparing obicetrapib versus placebo in efficacy and safety outcomes.
New Insights into the Potential of Obicetrapib, a Cholesteryl ...Obicetrapib lowers LDL-C, raises HDL-C, and, unique to this compound, also elevates HDL-E46, 47, an HDL subfraction of interest as a ...
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