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 (RUBENS)

NewAmsterdam Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Type 2 Diabetes (T2DM); Metabolic Syndrome (MetS); Lipidemia

Treatments: Drug: Obicetrapib 10 mg; Other: Placebo; Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219602

OBEZ-303

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

Obicetrapib/Ezetimibe

Experimental group

Description:

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Treatment:

Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Obicetrapib

Experimental group

Description:

obicetrapib 10 mg daily

Treatment:

Drug: Obicetrapib 10 mg

Placebo

Placebo Comparator group

Description:

Placebo on top of guideline-recommended lipid-lowering therapy

Treatment:

Other: Placebo

Open-Label Extension

Experimental group

Description:

Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg

Treatment:

Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily