Recent Updates
Recently added Catalysts

Obicetrapib

Phase 4

Atherosclerotic Cardiovascular Disease | Small molecule | Cardiovascular |NewAmsterdam Pharma Company N.V.|Trials Updated: Aug 31, 2026

Obicetrapib development status

Highest phase Phase 4 run by Organon and Co (NCT00651963)
Phase scored for NAMSPhase 3
Registered trials 109 across 23 sponsors since Sep 2004

Obicetrapib target and mechanism

Molecular targetCETP
Target classInhibitor
ModalitySmall molecule

Also known as Monotherapy obicetrapib, Cholesteryl ester transfer protein (CETP) inhibitor, ezetimibe, CETP-inhibitor, TA-8995

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials15
Total Enrollment14,489

FDA Designations

No designations recorded

Obicetrapib clinical trials

Obicetrapib · 15 trials · 21 indications

Phase 3 6Phase 2 8Phase 1 1
NCT06305559A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary PlaqueLipidemia
RECRUITING300 Analytics
NCT05142722Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying TherapiesDyslipidemias
COMPLETED2,530 Analytics
NCT05202509Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular DiseaseAtherosclerotic Cardiovascular Disease
ACTIVE NOT_RECRUITING9,541 Analytics
NCT06005597Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying TherapiesDyslipidemias
COMPLETED407 Analytics
NCT07219602A 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 SyndromeLipidemia
RECRUITING300 Analytics
NCT05425745Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.Dyslipidemias
COMPLETED354 Analytics
PHASE3RECRUITING
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
LipidemiaUnlock trial analytics
PHASE3COMPLETED
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
DyslipidemiasUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
Atherosclerotic Cardiovascular DiseaseUnlock trial analytics
PHASE3COMPLETED
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
DyslipidemiasUnlock trial analytics
PHASE3RECRUITING
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
LipidemiaUnlock trial analytics
PHASE3COMPLETED
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
DyslipidemiasUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline to Week 52 in ptau 217
Baseline, Week 52

Secondary Endpoints

Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio
Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio
Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio
Baseline, Week 52
Unlock Study Endpoints

Study Design & Arms

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
ObicetrapibEXPERIMENTAL10 mg Obicetrapib, once daily

Interventions

NameTypeDescription
obicetrapib 10 mg + ezetimibe 10 mg FDC dailyDRUGActive treatment
PlaceboOTHERBaseline lipid modifying therapy
ObicetrapibDRUG10mg obicetrapib tablet
Combination TherapyCOMBINATION_PRODUCTtablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Monotherapy obicetrapibDRUGtablet; 10mg obicetrapib
Monotherapy ezetimibeDRUGcapsule; 10mg ezetimibe
Combination Therapy placeboOTHERtablet; no active ingredient
Obicetrapib PlaceboOTHERtablet; no active ingredient
Ezetimibe PlaceboOTHERcapsule; no active ingredient
Obicetrapib 10 mgDRUGmonotherapy
Ezetimibe 10mgDRUGcapsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeksDRUG10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks
Obicetrapib 10mgDRUGActive Drug
Obicetrapib 5mgDRUGtablet
Matching placebo tabletsDRUGmatching placebo tablet
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to 85 Years
SexALL

Inclusion Criteria: * participants with preclinical AD Exclusion Criteria: * APOE genotype not meeting protocol-defined eligibility criteria

Unlock Eligibility Criteria

Frequently asked questions about Obicetrapib

What is obicetrapib?

Obicetrapib is an investigational small molecule CETP inhibitor being developed by NewAmsterdam Pharma Company N.V. (ticker NAMS). It is in clinical development across several indications, including atherosclerotic cardiovascular disease, dyslipidemia, lipid metabolism disorders, antioxidant absorption, and early Alzheimer's disease.

What does obicetrapib target?

Obicetrapib targets CETP, cholesteryl ester transfer protein, and acts as a CETP inhibitor. By inhibiting CETP, obicetrapib is designed to affect lipid metabolism and cholesterol transport. It is a small molecule being studied in dyslipidemia, atherosclerotic cardiovascular disease, and related lipid disorders.

Who makes obicetrapib?

Obicetrapib is being developed by NewAmsterdam Pharma Company N.V., which trades under the ticker NAMS. The company is the sponsor of the clinical trial program evaluating obicetrapib as monotherapy and in combination regimens, including with ezetimibe and with evolocumab.

What phase is obicetrapib in?

Obicetrapib is in clinical development, with trials spanning Phase 2 and Phase 3. It is investigational and has not been approved by the FDA. The program includes eight trials in total, with two currently active and seven completed, enrolling 9,541 participants overall.

What clinical trials is obicetrapib in?

Obicetrapib trials include NCT07794670, a Phase 2 study in preclinical Alzheimer's disease; NCT07219602, a Phase 3 study in type 2 diabetes and metabolic syndrome; NCT06982508, a Phase 2 antioxidant study in healthy volunteers; and NCT06496243, a Phase 2 study of obicetrapib and obicetrapib plus Repatha on Lp(a) levels.