NewAmsterdam Pharma Co N.V. (NAMS)
NewAmsterdam Pharma Company N.V., a late-stage biopharmaceutical company, develops therapies to enhance patient care in populations with cardiometabolic disease. It is developing Obicetrapib, an oral low-dose cholesteryl ester transfer protein (CETP) inhibitor, that is in various clinical trials as a monotherapy and a combination therapy with ezetimibe for lowering LDL-C for cardiovascular diseases. The company also develops Obicetrapib which is in Phase 2a clinical trial for Alzheimer’s disease. NewAmsterdam Pharma Company N.V. is headquartered in Naarden, the Netherlands.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
NewAmsterdam Pharma Company N.V.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
Placebo, Obicetrapib
Dyslipidemias, High Cholesterol +3
NCT05142722Enrollment2,530StartDec 2021Primary CompletionSep 2024CompletionSep 2024 - Phase 3Active, not recruiting
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
Obicetrapib, Placebo
Atherosclerotic Cardiovascular Disease
NCT05202509Enrollment9,541StartFeb 2022Primary CompletionNov 2026est.CompletionNov 2026est. - Phase 3Completed
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
Obicetrapib, Placebo
Dyslipidemias, High Cholesterol +7
NCT05425745Enrollment354StartJul 2022Primary CompletionMay 2024CompletionMay 2024 - Phase 3Completed
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
Monotherapy obicetrapib, Monotherapy ezetimibe
Dyslipidemias, Hypercholesterolemia +3
NCT06005597Enrollment407StartMar 2024Primary CompletionSep 2024CompletionOct 2024 - Phase 3Active, not recruiting
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Lipidemia, Coronary Artery Disease +1
NCT06305559Enrollment300StartMay 2024Primary CompletionNov 2027est.CompletionFeb 2028est. - Phase 3Active, not recruiting
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
obicetrapib 10 mg + ezetimibe 10 mg FDC daily, Obicetrapib 10 mg
Lipidemia, Type 2 Diabetes (T2DM) +1
NCT07219602Enrollment300StartDec 2025Primary CompletionMar 2028est.CompletionJun 2028est. - Phase 2Completed
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Obicetrapib
Dyslipidemias, High Cholesterol +1
NCT04753606Enrollment120StartFeb 2021Primary CompletionMay 2021CompletionAug 2021 - Phase 2Completed
Randomized Study of Obicetrapib in Combination With Ezetimibe
Obicetrapib 5mg, Ezetimibe 10mg
Dyslipidemias, High Cholesterol +1
NCT04770389Enrollment112StartFeb 2021Primary CompletionMay 2021CompletionJun 2021 - Phase 2Completed
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
Obicetrapib
Early Alzheimer's Disease
NCT05161715Enrollment13StartJan 2022Primary CompletionMay 2023CompletionJun 2023 - Phase 2Completed
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Obicetrapib, Ezetimibe 10mg
Dyslipidemias, High Cholesterol +1
NCT05266586Enrollment119StartMar 2022Primary CompletionAug 2022CompletionSep 2022 - Phase 2Completed
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
Obicetrapib, Placebo
Dyslipidemia, Hypercholesterolemia +1
NCT05421078Enrollment102StartJun 2022Primary CompletionMar 2023CompletionApr 2023 - Phase 2Recruiting
Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels
obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks
Dyslipidemias
NCT06496243Enrollment69StartDec 2024Primary CompletionNov 2026est.CompletionFeb 2027est. - Phase 2Recruiting
Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers
Obicetrapib 10mg, Placebo
Antioxidant Absorption
NCT06982508Enrollment100StartSep 2025Primary CompletionSep 2026est.CompletionDec 2026est. - Phase 2Recruiting
Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease
Obicetrapib 10 mg, Matching placebo tablets
Preclinical Alzheimer's Disease
NCT07794670Enrollment400StartSep 2026est.Primary CompletionSep 2028est.CompletionMay 2029est. - Phase 1Unknown status
Investigating the Effect of Obicetrapib on Lipoprotein Metabolism
Obicetrapib
Lipid Metabolism
NCT05972278Enrollment22StartDec 2023Primary CompletionSep 2024est.CompletionOct 2024est. - Phase 1Completed
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
Obicetrapib
Hepatic Impairment, Healthy
NCT06048302Enrollment18StartNov 2023Primary CompletionMar 2024CompletionMar 2024 - Phase 1Completed
Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe
Fixed-Dose Combination (FDC) Tablet
Healthy Volunteer Study
NCT06050291Enrollment28StartJan 2024Primary CompletionApr 2024CompletionApr 2024 - Phase 1Completed
A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin
Obicetrapib, Atorvastatin Calcium
Healthy Volunteers
NCT06081166Enrollment74StartNov 2023Primary CompletionDec 2023CompletionJan 2024 - Phase 1Completed
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
Obicetrapib, Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)
Healthy Volunteers
NCT06250205Enrollment30StartFeb 2024Primary CompletionApr 2024CompletionApr 2024 - Phase 1Completed
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
Obicetrapib 10mg, Ezetimibe 10mg
Healthy Volunteers
NCT06547359Enrollment94StartOct 2024Primary CompletionNov 2024CompletionNov 2024
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Placebo, Obicetrapib | NCT05142722 |
| Phase 3 | Active, not recruiting | Obicetrapib, Placebo | NCT05202509 |
| Phase 3 | Completed | Obicetrapib, Placebo | NCT05425745 |
| Phase 3 | Completed | Monotherapy obicetrapib, Monotherapy ezetimibe | NCT06005597 |
| Phase 3 | Active, not recruiting | obicetrapib 10 mg + ezetimibe 10 mg FDC daily | NCT06305559 |
| Phase 3 | Active, not recruiting | obicetrapib 10 mg + ezetimibe 10 mg FDC daily, Obicetrapib 10 mg | NCT07219602 |
| Phase 2 | Completed | Obicetrapib | NCT04753606 |
| Phase 2 | Completed | Obicetrapib 5mg, Ezetimibe 10mg | NCT04770389 |
| Phase 2 | Completed | Obicetrapib | NCT05161715 |
| Phase 2 | Completed | Obicetrapib, Ezetimibe 10mg | NCT05266586 |
| Phase 2 | Completed | Obicetrapib, Placebo | NCT05421078 |
| Phase 2 | Recruiting | obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks | NCT06496243 |
| Phase 2 | Recruiting | Obicetrapib 10mg, Placebo | NCT06982508 |
| Phase 2 | Recruiting | Obicetrapib 10 mg, Matching placebo tablets | NCT07794670 |
| Phase 1 | Unknown status | Obicetrapib | NCT05972278 |
| Phase 1 | Completed | Obicetrapib | NCT06048302 |
| Phase 1 | Completed | Fixed-Dose Combination (FDC) Tablet | NCT06050291 |
| Phase 1 | Completed | Obicetrapib, Atorvastatin Calcium | NCT06081166 |
| Phase 1 | Completed | Obicetrapib, Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) | NCT06250205 |
| Phase 1 | Completed | Obicetrapib 10mg, Ezetimibe 10mg | NCT06547359 |