A Phase 3 interventional study of obicetrapib 10 mg + ezetimibe 10 mg FDC daily and Obicetrapib 10 mg in Lipidemia, Type 2 Diabetes (T2DM) and Metabolic Syndrome (MetS), sponsored by NewAmsterdam Pharma. Active, not recruiting at 55 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by NewAmsterdam Pharma · Phase 3, Interventional, and Prevention
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.
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's planned enrollment of 300 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily
obicetrapib 10 mg daily
Drug: Obicetrapib 10 mg
Placebo on top of guideline-recommended lipid-lowering therapy
Other: Placebo
Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg
Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Drug page: TA-8995
FDC
monotherapy
placebo on top of guideline-recommended lipid modifying therapy
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
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
Percent change from Baseline over time in LDL-C
The percent change from Baseline at every visit for LDL-C
Time frame: 40 weeks
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)
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)
Time frame: 40 weeks
Percent change from Baseline over time in non-HDL-C
The percent change from Baseline at every visit for non-HDL-C
Time frame: 40 weeks
Percent change from Baseline over time in ApoB
The percent change from Baseline at every visit in ApoB
Time frame: 40 weeks
Percent change from Baseline over time in total cholesterol
The percent change from Baseline at every visit for total cholesterol
Time frame: 40 weeks
Percent change from Baseline over time in triglycerides
The percent change from baseline at every visit for triglycerides
Time frame: 40 weeks
Percent change from Baseline over time in HDL-C
the percent change from Baseline at every visit for HDL-C
Time frame: 40 weeks
Percent change from Baseline over time in Lp(a)
the percent change from Baseline at every visit for Lp(a)
Time frame: 40 weeks
Plan to share: Yes
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: TA-8995
NewAmsterdam Pharma