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NCT07219602 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome
A Phase 3 study of Type 2 Diabetes (T2DM) and Lipidemia, sponsored by NewAmsterdam Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT07219602 is a Phase 3 study of Type 2 Diabetes (T2DM) and Lipidemia that is actively recruiting participants, run by NewAmsterdam Pharma. The registered enrollment target is 300 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT07219602, a Phase 3 study of Type 2 Diabetes (T2DM) and Lipidemia, is actively recruiting participants, sponsored by NewAmsterdam Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG obicetrapib 10 mg + ezetimibe 10 mg FDC daily
- DRUG Obicetrapib 10 mg
Study Locations (20)
Florida
- UF Health Jackson - Jacksonville
- East Coast Institute of Research LLC - Jacksonville
- East Coast Institute of Research LLC - Lake City
- Floridian Clinical Research - Miami Lakes
North Carolina
- Velocity Clinical Research - Durham
- Floridian Clinical Research - Greensboro
- Centricity Research dba Lucas Research - Morehead City
Texas
- Juno Research LLC - Medical Center - Houston
- Clinical Trials of Texas dba Flourish Research - San Antonio
Virginia
- Burke Internal Medicine - Burke
- Burke International Medicine DBA Manassas Clinical Research Center - Manassas
Arizona
- Clinical Research Institute of Arizona - Sun City West
California
- Scripps Health - Whittier Diabetes Institute - La Jolla
Kentucky
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC) - Louisville
Maryland
- MD Medical Research - Oxon Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-12-11 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07219602
The ClinicalTrials.gov registry entry for NCT07219602 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 300 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 3 conditions, with Type 2 Diabetes (T2DM) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT07219602 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT07219602 about?
NCT07219602 is a clinical study titled "A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome". This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients...
What is the current status of trial NCT07219602?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2025-12-11. Estimated completion is 2028-06.
What conditions does trial NCT07219602 study?
This clinical trial studies the following conditions: Type 2 Diabetes (T2DM), Lipidemia, Metabolic Syndrome (MetS).
What interventions are being tested in trial NCT07219602?
The interventions under investigation include: Placebo (OTHER), obicetrapib 10 mg + ezetimibe 10 mg FDC daily (DRUG), Obicetrapib 10 mg (DRUG).
Who is sponsoring clinical trial NCT07219602?
This trial is sponsored by NewAmsterdam Pharma, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07219602 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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