LipidemiaPhase 3RUBENSNCT07219602

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 Phase 3 study testing obicetrapib 10 mg + ezetimibe 10 mg FDC daily and Obicetrapib 10 mg in people with Lipidemia and Type 2 Diabetes (T2DM), run by NewAmsterdam Pharma at 55 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)
What is being tested?: obicetrapib 10 mg + ezetimibe 10 mg FDC daily and Obicetrapib 10 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 55 sitesin 4 countries
Study dates: 11 Dec 2025to Jun 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

55 sites in 4 countries.

Country

City, postcode or hospital

55 sites in 4 countries

United States32 sites

Eastern Maine Medical Center
Bangor, Maine, 04401
Inspira Health - Internal Medicine Associates
Bridgeton, New Jersey, 08302
Burke Internal Medicine
Burke, Virginia, 22015-2234
Duke University Medical Center
Durham, North Carolina, 27710
Velocity Clinical Research
Durham, North Carolina, 27710
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408
Baylor College of Medicine - Center for Cardiometabolic Disease Prevention (The Center for Cardiovascular Disease Prevention)
Houston, Texas, 77030
Juno Research LLC - Medical Center
Houston, Texas, 77054
PlanIt Research, PLLC
Houston, Texas, 77079
UF Health Jackson
Jacksonville, Florida, 32209
East Coast Institute of Research LLC
Jacksonville, Florida, 32216
Jefferson City Medical Group
Jefferson City, Missouri, 65109
Diabetes & Glandular Disease Clinic, P.A.
Kingsport, Tennessee, 37660
Scripps Health - Whittier Diabetes Institute
La Jolla, California, 92037
UC SanDiego Health
La Jolla, California, 92037
East Coast Institute of Research LLC
Lake City, Florida, 32055
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213
K2 Medical Research
Maitland, Florida, 32751
Burke International Medicine DBA Manassas Clinical Research Center
Manassas, Virginia, 20110
Central New York Clinical Research
Manlius, New York, 13104
High Desert Heart
Meridian, Idaho, 83642
Floridian Clinical Research
Miami Lakes, Florida, 33016
Montana Medical Research
Missoula, Montana, 59808
Centricity Research dba Lucas Research
Morehead City, North Carolina, 28557
Summit Research Group
Munroe Falls, Ohio, 44262
MD Medical Research
Oxon Hill, Maryland, 20745
Western University of Health Sciences
Pomona, California, 91766
Clinical Trials of Texas dba Flourish Research
San Antonio, Texas, 78229
Cardiovascular Center of Sarasote Foundation for Research and Education
Sarasota, Florida, 34239-3513
Endeavour Health
Skokie, Illinois, 60077
Clinical Research Institute of Arizona
Sun City West, Arizona, 85375
Universal Research Group
Tacoma, Washington, 98405

Other trials in United States

Czechia11 sites

DOCTOR MN s.r.o
Čáslav, 286 01
MUDr. Alena Váchová
České Budějovice, 370 11
MEDIKA Hradec Králové, s.r.o.
Hradec Králové, 50002
Dien Servis s.r.o.
Humpolec, Vysocina, 39601
Interni diabetologicka ambulance (Pratia)
Jílové u Prahy, 252 42
Diabetologie - Dr. Tomas Edelsberger
Krnov, 79401
Pratia Pardubice a.s. (Pratia)
Pardubice, 53002
Dieko s.r.o
Pilsen, 30100
Nemocnice Na Františku
Prague, 11 000
Institut klinicke a experimentalni mediciny
Prague, 140 21
Fakultni Nemocnice (FN) v Motole (Motol University Hospital)
Prague, 15006

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Slovakia7 sites

Human-Care, s.r.o.
Košice, Košice Region, 4001
Pavol Jozef Šafárik University
Košice, Košice Region, 4022
Nemocnicna a.s
Malacky, 901 01
Funkystuff s.r.o.
Nové Zámky, Nitra Region, 940 02
DIA-GNOSIS, s.r.o.
Piešťany, Trnava Region, 92101
MUDr. Žáková s.r.o.
Trenčín, Trenčín Region, 91101
JAL s.r.o.
Trnava, Trnava Region, 917 01

Other trials in Slovakia

Netherlands5 sites

Noordwest Ziekenhuisgroep - Alkmaar
Alkmaar, North Holland, 1815JD
Rijnstate Ziekenhuis
Arnhem, Gelderland, 6815AD
Deventer Ziekenhuis
Deventer, Overijssel, 7416SE
Bethesda Diabetes Research Center
Hoogeveen, Drenthe, 7909AA
Albert Schweitzer Ziekenhuis
Zwijndrecht, South Holland, 3331LZ

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About this study

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)

Conditions: Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)
Being tested: obicetrapib 10 mg + ezetimibe 10 mg FDC daily, Obicetrapib 10 mg, Placebo
Medical subject headings: Hyperlipidemias, Diabetes Mellitus, Type 2, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

obicetrapib 10 mg + ezetimibe 10 mg FDC dailyDrug
FDC
Obicetrapib 10 mgDrug
monotherapy
PlaceboOther
placebo on top of guideline-recommended lipid modifying therapy

Study groups in NCT07219602
Study group	Role	What they receive
Obicetrapib/Ezetimibe	Experimental	obicetrapib 10 mg + ezetimibe 10 mg FDC daily Receives: Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Obicetrapib	Experimental	obicetrapib 10 mg daily Receives: Drug: Obicetrapib 10 mg
Placebo	Placebo comparator	Placebo on top of guideline-recommended lipid-lowering therapy Receives: Other: Placebo
Open-Label Extension	Experimental	Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg Receives: Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 84 days

Secondary outcomes (10)

Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Measured: Day 84
Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Measured: 84 days
Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Measured: 84 days
Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Measured: 84 days
Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group;
Measured: 84 days
Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: Day 84
Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: Day 84
Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: Day 84
Percent change from Baseline to Day 84 in lipoprotein (a) (Lp[a]) for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Measured: Day 84
Percent change from Baseline to Day 84 in Lp(a) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 2025Jun 2028

First posted22 Oct 2025
Study start11 Dec 2025
Primary completionMar 2028 (estimated)
Study completionJun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LipidemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: This protocol includes a 12-week, 3-arm, placebo-controlled, double-blind treatment section, followed by a 40-week open-label extension period. All patients receive the FDC of obicetrapib 10mg and ezetimibe 10 mg, regardless of the intervention received in the double-blind treatment section of this trial.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07219602
Sponsor's protocol ID: OBEZ-303
Acronym: RUBENS
Status last verified: Sep 2026
First submitted: 20 Oct 2025
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07219602
Acronym / sponsor ID: RUBENS / OBEZ-303
Conditions: Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: NewAmsterdam PharmaIndustry (pharma, biotech, devices)
Study start: 11 Dec 2025 (actual)
Primary completion: Mar 2028 (estimated)
Study completion: Jun 2028 (estimated)
First posted: 22 Oct 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: This protocol includes a 12-week, 3-arm, placebo-controlled, double-blind treatment section, followed by a 40-week open-label extension period. All patients receive the FDC of obicetrapib 10mg and ezetimibe 10 mg, regardless of the intervention received in the double-blind treatment section of this trial.

Arm	Type	Receives
Obicetrapib/Ezetimibe	Experimental	Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC dailyobicetrapib 10 mg + ezetimibe 10 mg FDC daily
Obicetrapib	Experimental	Drug: Obicetrapib 10 mgobicetrapib 10 mg daily
Placebo	Placebo comparator	Other: PlaceboPlacebo on top of guideline-recommended lipid-lowering therapy
Open-Label Extension	Experimental	Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC dailyOpen-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
obicetrapib 10 mg + ezetimibe 10 mg FDC dailyFDC	Drug	Obicetrapib/Ezetimibe, Open-Label Extension
Obicetrapib 10 mgmonotherapy	Drug	Obicetrapib
Placeboplacebo on top of guideline-recommended lipid modifying therapy	Other	Placebo

Primary outcome

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
Time frame: 84 days

10 secondary outcomes

Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Time frame: Day 84
Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Time frame: 84 days
Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Time frame: 84 days
Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Time frame: 84 days
Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group;
Time frame: 84 days
Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Time frame: Day 84
Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Time frame: Day 84
Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Time frame: Day 84
Percent change from Baseline to Day 84 in lipoprotein (a) (Lp[a]) for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group
Time frame: Day 84
Percent change from Baseline to Day 84 in Lp(a) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Time frame: Day 84

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

55 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing obicetrapib 10 mg + ezetimibe 10 mg FDC daily and Obicetrapib 10 mg in people with Lipidemia and Type 2 Diabetes (T2DM), run by NewAmsterdam Pharma at 55 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Czechia, Slovakia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07219602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.