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Fixed-Dose Combination

Phase 1

Undisclosed | Small molecule | Other |NewAmsterdam Pharma Company N.V.|Trials Updated: Jun 4, 2024

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Fixed-Dose Combination clinical trials

Fixed-Dose Combination · 1 trial · 1 indication

Phase 1 1
NCT06050291Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and EzetimibeHealthy Volunteer Study
COMPLETED28 Analytics
PHASE1COMPLETED
Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe
Healthy Volunteer StudyUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
Fixed-Dose Combination (FDC) TabletDRUGObicetrapib/Ezetimibe FDC tablet
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Frequently asked questions about Fixed-Dose Combination

What is the Fixed-Dose Combination developed by NewAmsterdam Pharma?

The Fixed-Dose Combination is an investigational small molecule tablet being developed by NewAmsterdam Pharma Company N.V. (ticker NAMS). It combines obicetrapib and ezetimibe in a single oral dose. The program is in Phase 1 clinical development, and the specific patient population it is intended to treat has not been disclosed.

What is the Fixed-Dose Combination used for?

The Fixed-Dose Combination is being studied as a single-tablet combination of obicetrapib and ezetimibe. Its intended therapeutic indication has not been publicly disclosed. The only completed clinical study to date was conducted in healthy volunteers and examined how food affects the absorption of the combination, not a disease endpoint.

Who makes the Fixed-Dose Combination tablet?

NewAmsterdam Pharma Company N.V., which trades under the ticker NAMS, is the developer of the Fixed-Dose Combination tablet. The company is running the clinical development program for this obicetrapib and ezetimibe combination product.

What phase is the Fixed-Dose Combination in?

The Fixed-Dose Combination is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active. That completed study enrolled 28 participants.

What clinical trial has studied the Fixed-Dose Combination?

One clinical trial has evaluated the Fixed-Dose Combination: NCT06050291, titled Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe. The Phase 1 study enrolled 28 healthy volunteers, was uncontrolled, and has been completed. It assessed food effects on bioavailability rather than efficacy.