NCT07219602Active, not recruitingPhase 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 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)
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 20 Oct 2025
- Start date
- 11 Dec 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- NewAmsterdam Pharma
- Diseases
- Type 2 diabetes
- NCT number
- NCT07219602
- EU CT number
- 2025-521936-12-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 11 Dec 2025 to the primary completion date, 31 Mar 2028
- 56 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have been hospitalized for heart failure within 5 years prior to Screening
Other illness
- Have uncontrolled severe hypertension
- active liver disease
Lab values
- Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30%
- HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
Other
- Have a formal diagnosis of homozygous familial hypercholesterolemia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DOCTOR MN s.r.o Coordinator of this site? Confirm its status | Čáslav | Czechia | Active, not recruiting |
| MUDr. Alena Vachova Coordinator of this site? Confirm its status | České Budějovice | Czechia | Active, not recruiting |
| Medika Hradec Králové s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Active, not recruiting |
| Dien Servis s.r.o. Coordinator of this site? Confirm its status | Humpolec | Czechia | Active, not recruiting |
| Diavital Jesenice s.r.o. Coordinator of this site? Confirm its status | Jilove U Prahy | Czechia | Active, not recruiting |
| MUDr. Tomas Edelsberger Coordinator of this site? Confirm its status | Krnov | Czechia | Active, not recruiting |
| Edumed s.r.o. Coordinator of this site? Confirm its status | Náchod | Czechia | Active, not recruiting |
| Pratia Pardubice a.s. Coordinator of this site? Confirm its status | Pardubice I | Czechia | Active, not recruiting |
| Dieko s.r.o. Coordinator of this site? Confirm its status | Plzen 1 | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Nemocnice Na Františku Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Noordwest Ziekenhuisgroep Stichting Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Active, not recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Active, not recruiting |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Active, not recruiting |
| Bethesda Diabetes Research Center B.V. Coordinator of this site? Confirm its status | Hoogeveen | Netherlands | Active, not recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Zwijndrecht | Netherlands | Active, not recruiting |
| Cardio D&R s.r.o. Kosice Coordinator of this site? Confirm its status | Košice | Slovakia | Active, not recruiting |
| Human-Care s.r.o. Coordinator of this site? Confirm its status | Kosice 1 | Slovakia | Active, not recruiting |
| Nemocnicna a.s Coordinator of this site? Confirm its status | Malacky | Slovakia | Active, not recruiting |
| FUNKYSTUFF s.r.o. Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Active, not recruiting |
| DIA-GNOSIS, s.r.o. Coordinator of this site? Confirm its status | Piešťany | Slovakia | Active, not recruiting |
| MUDr. Žáková s.r.o. Coordinator of this site? Confirm its status | Trenčín | Slovakia | Active, not recruiting |
| JAL s.r.o. Coordinator of this site? Confirm its status | Trnava | Slovakia | Active, not recruiting |
| Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Inspira Health - Internal Medicine Associates Coordinator of this site? Confirm its status | Bridgeton | United States | Unknown status |
| Burke Internal Medicine Coordinator of this site? Confirm its status | Burke | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| PharmQuest Life Sciences LLC Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Juno Research LLC - Medical Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Baylor College of Medicine - Center for Cardiometabolic Disease Prevention (The Center for Cardiovascular Disease Prevention) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| East Coast Institute of Research LLC Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| UF Health Jackson Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Jefferson City Medical Group Coordinator of this site? Confirm its status | Jefferson City | United States | Unknown status |
| Diabetes & Glandular Disease Clinic, P.A. Coordinator of this site? Confirm its status | Kingsport | United States | Unknown status |
| UC SanDiego Health Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Scripps Health - Whittier Diabetes Institute Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| East Coast Institute of Research LLC Coordinator of this site? Confirm its status | Lake City | United States | Unknown status |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Burke International Medicine DBA Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Central New York Clinical Research Coordinator of this site? Confirm its status | Manlius | United States | Unknown status |
| High Desert Heart Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| Floridian Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Montana Medical Research Coordinator of this site? Confirm its status | Missoula | United States | Unknown status |
| Centricity Research dba Lucas Research Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Summit Research Group Coordinator of this site? Confirm its status | Munroe Falls | United States | Unknown status |
| MD Medical Research Coordinator of this site? Confirm its status | Oxon Hill | United States | Unknown status |
| Western University of Health Sciences Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
| Clinical Trials of Texas dba Flourish Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Cardiovascular Center of Sarasote Foundation for Research and Education Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Endeavour Health Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Clinical Research Institute of Arizona Coordinator of this site? Confirm its status | Sun City West | United States | Unknown status |
| Universal Research Group Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.