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NCT Number: NCT07219602

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

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.

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Key information

Conditions

Lipidemia Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Metabolic Syndrome (MetS) Nutritional and Metabolic Diseases Type 2 Diabetes (T2DM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Institute of Arizona, Sun City West, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Drug

FDC

Obicetrapib 10 mg

Drug

monotherapy

Placebo

Other

placebo on top of guideline-recommended lipid modifying therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Other outcomes

  1. Percent change from Baseline over time in LDL-C

    Time frame: 40 weeks

    The percent change from Baseline at every visit for LDL-C

  2. Proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L)

    Time frame: 40 weeks

    The percent change from Baseline at every visit in the proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L)

  3. Percent change from Baseline over time in non-HDL-C

    Time frame: 40 weeks

    The percent change from Baseline at every visit for non-HDL-C

  4. Percent change from Baseline over time in ApoB

    Time frame: 40 weeks

    The percent change from Baseline at every visit in ApoB

  5. Percent change from Baseline over time in total cholesterol

    Time frame: 40 weeks

    The percent change from Baseline at every visit for total cholesterol

  6. Percent change from Baseline over time in triglycerides

    Time frame: 40 weeks

    The percent change from baseline at every visit for triglycerides

  7. Percent change from Baseline over time in HDL-C

    Time frame: 40 weeks

    the percent change from Baseline at every visit for HDL-C

  8. Percent change from Baseline over time in Lp(a)

    Time frame: 40 weeks

    the percent change from Baseline at every visit for Lp(a)

Study contacts

Contact information is provided by the study sponsor or research team.

Gagandeep Dhillon

CONTACT

[email protected]

519-209-2341

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study 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)

Acronym: RUBENS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 22, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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