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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
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

Full criteria on ClinicalTrials.gov

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
DOCTOR MN s.r.o
Coordinator of this site? Confirm its status
ČáslavCzechiaActive, not recruiting
MUDr. Alena Vachova
Coordinator of this site? Confirm its status
České BudějoviceCzechiaActive, not recruiting
Medika Hradec Králové s.r.o.
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaActive, not recruiting
Dien Servis s.r.o.
Coordinator of this site? Confirm its status
HumpolecCzechiaActive, not recruiting
Diavital Jesenice s.r.o.
Coordinator of this site? Confirm its status
Jilove U PrahyCzechiaActive, not recruiting
MUDr. Tomas Edelsberger
Coordinator of this site? Confirm its status
KrnovCzechiaActive, not recruiting
Edumed s.r.o.
Coordinator of this site? Confirm its status
NáchodCzechiaActive, not recruiting
Pratia Pardubice a.s.
Coordinator of this site? Confirm its status
Pardubice ICzechiaActive, not recruiting
Dieko s.r.o.
Coordinator of this site? Confirm its status
Plzen 1CzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Nemocnice Na Františku
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PragueCzechiaActive, not recruiting
Institute for Clinical and Experimental Medicine
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PragueCzechiaActive, not recruiting
Noordwest Ziekenhuisgroep Stichting
Coordinator of this site? Confirm its status
AlkmaarNetherlandsActive, not recruiting
Rijnstate Ziekenhuis Stichting
Coordinator of this site? Confirm its status
ArnhemNetherlandsActive, not recruiting
Deventer Ziekenhuis
Coordinator of this site? Confirm its status
DeventerNetherlandsActive, not recruiting
Bethesda Diabetes Research Center B.V.
Coordinator of this site? Confirm its status
HoogeveenNetherlandsActive, not recruiting
Albert Schweitzer Ziekenhuis
Coordinator of this site? Confirm its status
ZwijndrechtNetherlandsActive, not recruiting
Cardio D&R s.r.o. Kosice
Coordinator of this site? Confirm its status
KošiceSlovakiaActive, not recruiting
Human-Care s.r.o.
Coordinator of this site? Confirm its status
Kosice 1SlovakiaActive, not recruiting
Nemocnicna a.s
Coordinator of this site? Confirm its status
MalackySlovakiaActive, not recruiting
FUNKYSTUFF s.r.o.
Coordinator of this site? Confirm its status
Nové ZámkySlovakiaActive, not recruiting
DIA-GNOSIS, s.r.o.
Coordinator of this site? Confirm its status
PiešťanySlovakiaActive, not recruiting
MUDr. Žáková s.r.o.
Coordinator of this site? Confirm its status
TrenčínSlovakiaActive, not recruiting
JAL s.r.o.
Coordinator of this site? Confirm its status
TrnavaSlovakiaActive, not recruiting
Eastern Maine Medical Center
Coordinator of this site? Confirm its status
BangorUnited StatesUnknown status
Inspira Health - Internal Medicine Associates
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BridgetonUnited StatesUnknown status
Burke Internal Medicine
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BurkeUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Velocity Clinical Research
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DurhamUnited StatesUnknown status
PharmQuest Life Sciences LLC
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GreensboroUnited StatesUnknown status
PlanIt Research, PLLC
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Juno Research LLC - Medical Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Baylor College of Medicine - Center for Cardiometabolic Disease Prevention (The Center for Cardiovascular Disease Prevention)
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
East Coast Institute of Research LLC
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
UF Health Jackson
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Jefferson City Medical Group
Coordinator of this site? Confirm its status
Jefferson CityUnited StatesUnknown status
Diabetes & Glandular Disease Clinic, P.A.
Coordinator of this site? Confirm its status
KingsportUnited StatesUnknown status
UC SanDiego Health
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Scripps Health - Whittier Diabetes Institute
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La JollaUnited StatesUnknown status
East Coast Institute of Research LLC
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Lake CityUnited StatesUnknown status
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
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LouisvilleUnited StatesUnknown status
K2 Medical Research
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MaitlandUnited StatesUnknown status
Burke International Medicine DBA Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Central New York Clinical Research
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ManliusUnited StatesUnknown status
High Desert Heart
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MeridianUnited StatesUnknown status
Floridian Clinical Research
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Miami LakesUnited StatesUnknown status
Montana Medical Research
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MissoulaUnited StatesUnknown status
Centricity Research dba Lucas Research
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Morehead CityUnited StatesUnknown status
Summit Research Group
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Munroe FallsUnited StatesUnknown status
MD Medical Research
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Oxon HillUnited StatesUnknown status
Western University of Health Sciences
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PomonaUnited StatesUnknown status
Clinical Trials of Texas dba Flourish Research
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San AntonioUnited StatesUnknown status
Cardiovascular Center of Sarasote Foundation for Research and Education
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SarasotaUnited StatesUnknown status
Endeavour Health
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SkokieUnited StatesUnknown status
Clinical Research Institute of Arizona
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Sun City WestUnited StatesUnknown status
Universal Research Group
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TacomaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.