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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07219602

Public ClinicalTrials.gov record NCT07219602. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and 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 (RUBENS Trial)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07219602
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
NewAmsterdam Pharma
Industry
Enrollment
300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 10, 2025
Primary completion
Feb 29, 2028
Completion
May 31, 2028
Last update posted
Mar 9, 2026

2025 – 2028

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
19
Facility City State ZIP Site status
Clinical Research Institute of Arizona Sun City West Arizona 85375 Recruiting
Scripps Health - Whittier Diabetes Institute La Jolla California 92037 Recruiting
UF Health Jackson Jacksonville Florida 32209 Recruiting
East Coast Institute of Research LLC Jacksonville Florida 32216 Recruiting
East Coast Institute of Research LLC Lake City Florida 32055 Recruiting
Floridian Clinical Research Miami Lakes Florida 33016 Recruiting
Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Louisville Kentucky 40213 Recruiting
MD Medical Research Oxon Hill Maryland 20745 Recruiting
Jefferson City Medical Group Jefferson City Missouri 65109 Recruiting
Montana Medical Research Missoula Montana 59808 Recruiting
Inspira Health - Internal Medicine Associates Bridgeton New Jersey 08302 Recruiting
Central New York Clinical Research Manlius New York 13104 Recruiting
Velocity Clinical Research Durham North Carolina 27710 Recruiting
Floridian Clinical Research Greensboro North Carolina 27408 Recruiting
Centricity Research dba Lucas Research Morehead City North Carolina 28557 Recruiting
Summit Research Group Munroe Falls Ohio 44262 Recruiting
Juno Research LLC - Medical Center Houston Texas 77054 Recruiting
Clinical Trials of Texas dba Flourish Research San Antonio Texas 78229 Recruiting
Burke Internal Medicine Burke Virginia 22015-2234 Recruiting
Burke International Medicine DBA Manassas Clinical Research Center Manassas Virginia 20110 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07219602, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 9, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07219602 live on ClinicalTrials.gov.

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