Lipidemia, Metabolic Syndrome (MetS), Type 2 Diabetes (T2DM)
Conditions
Brief 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 syndrome and/or Type 2 Diabetes Mellitus.
Interventions
monotherapy
OTHERPlacebo
placebo on top of guideline-recommended lipid modifying therapy
Sponsors
NewAmsterdam Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 84 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 | 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 | 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; | 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 | Day 84 |
| Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group | Day 84 |
| Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group | 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 | 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 | Day 84 |
Countries
Czechia, Netherlands, Slovakia, United States
Outcome results
None listed