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RECRUITING 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

NCT07219602 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 300 participants
Start Date 2025-12-11
Est. Completion 2028-06
Phase Phase 3

Sponsor

NewAmsterdam Pharma

7 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07219602 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07219602?

This trial is sponsored by NewAmsterdam Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial