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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 · NewAmsterdam Pharma
In plain English
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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)
About this study
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.
Eligibility criteria
Inclusion Criteria:
* fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
* Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L)
* Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors
* Are on stable guideline-recommended lipid-lowering therapy
* Estimated glomerular filtration rate ≥15 mL/min/1.73 m2
Exclusion Criteria:
* Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30%
* Have been hospitalized for heart failure within 5 years prior to Screening
* Have uncontrolled severe hypertension
* Have a formal diagnosis of homozygous familial hypercholesterolemia
* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
* active liver disease
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-12-11
Estimated completion: 2028-06
Last updated: 2026-03-10
Interventions
Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC dailyDrug: Obicetrapib 10 mgOther: Placebo
Primary outcomes
- • The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group (84 days)
Sponsor
NewAmsterdam Pharma · industry
Contacts & investigators
ContactGagandeep Dhillon · contact · Gagandeep.dhillon@fortrea.com · 519-209-2341
All locations (20)
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East Coast Institute of Research LLCRecruiting
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MD Medical ResearchRecruiting
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Jefferson City Medical GroupRecruiting
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Velocity Clinical ResearchRecruiting
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Centricity Research dba Lucas ResearchRecruiting
Morehead City, North Carolina, United States
Summit Research GroupRecruiting
Munroe Falls, Ohio, United States
Juno Research LLC - Medical CenterRecruiting
Houston, Texas, United States
Clinical Trials of Texas dba Flourish ResearchRecruiting
San Antonio, Texas, United States
Burke Internal MedicineRecruiting
Burke, Virginia, United States
Burke International Medicine DBA Manassas Clinical Research CenterRecruiting
Manassas, Virginia, United States