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NCT06005597 · ClinicalTrials.gov registry record · Phase 3
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
A Phase 3 study, sponsored by NewAmsterdam Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT06005597 is a Phase 3 study that has completed, run by NewAmsterdam Pharma. The registered enrollment target is 407 participants.
The verdict
NCT06005597, a Phase 3 study, has completed, sponsored by NewAmsterdam Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Interventions
- COMBINATION_PRODUCT Combination Therapy
- DRUG Monotherapy obicetrapib
- DRUG Monotherapy ezetimibe
- OTHER Combination Therapy placebo
- OTHER Obicetrapib Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2024-10-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06005597
The ClinicalTrials.gov registry entry for NCT06005597 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 407 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewAmsterdam Pharma, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Combination Therapy is the first listed.
NCT06005597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06005597 about?
NCT06005597 is a clinical study titled "Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies". The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg...
What is the current status of trial NCT06005597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2024-03-01. Estimated completion is 2024-10-16.
What interventions are being tested in trial NCT06005597?
The interventions under investigation include: Combination Therapy (COMBINATION_PRODUCT), Monotherapy obicetrapib (DRUG), Monotherapy ezetimibe (DRUG), Combination Therapy placebo (OTHER), Obicetrapib Placebo (OTHER).
Who is sponsoring clinical trial NCT06005597?
This trial is sponsored by NewAmsterdam Pharma, which has 15 total clinical trials registered on ClinicalTrials.gov.
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