NewAmsterdam Pharma Company N.V.

🇳🇱Netherlands

Country: 🇳🇱Netherlands

Ownership: -

Employees: -

Market Cap: $1.5B

Website

Clinical Trials

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Obicetrapib 10mg
Drug: Ezetimibe 10mg

First Posted Date: 2024-08-09

Last Posted Date: 2024-11-14

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 94

Registration Number: NCT06547359

Locations: 🇨🇦
PharmaMedica Research Inc., Toronto, Ontario, Canada

Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels

Phase 2

Recruiting

Conditions: Dyslipidemias

Interventions: Drug: obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks

First Posted Date: 2024-07-11

Last Posted Date: 2024-11-14

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 30

Registration Number: NCT06496243

Locations: 🇺🇸
UPenn, Philadelphia, Pennsylvania, United States

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

Phase 3

Recruiting

Conditions: Lipidemia
Coronary Artery Disease
Plaque, Atherosclerotic

Interventions: Other: Placebo
Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

First Posted Date: 2024-03-12

Last Posted Date: 2024-11-14

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 300

Registration Number: NCT06305559

Locations: 🇺🇸
NGMR, Hialeah, Florida, United States

Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

Phase 1

Recruiting

Conditions: Healthy Volunteers

Interventions: Drug: Drospirenone / Ethinyl Estradiol (COC)
Drug: Obicetrapib
Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)

First Posted Date: 2024-02-08

Last Posted Date: 2024-02-15

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 30

Registration Number: NCT06250205

Locations: 🇺🇸
NOVUM, Las Vegas, Nevada, United States

A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Obicetrapib
Drug: Atorvastatin Calcium
Drug: Rosuvastatin Calcium

First Posted Date: 2023-10-13

Last Posted Date: 2024-02-05

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 74

Registration Number: NCT06081166

Locations: 🇨🇦
Mark M Feldman, Toronto, Ontario, Canada

Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe

Phase 1

Completed

Conditions: Healthy Volunteer Study

Interventions: Drug: Fixed-Dose Combination (FDC) Tablet

First Posted Date: 2023-09-22

Last Posted Date: 2024-06-05

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 28

Registration Number: NCT06050291

Locations: 🇺🇸
NOVUM, Las Vegas, Nevada, United States

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

Phase 1

Recruiting

Conditions: Hepatic Impairment
Healthy

Interventions: Drug: Obicetrapib

First Posted Date: 2023-09-21

Last Posted Date: 2024-01-23

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 16

Registration Number: NCT06048302

Locations: 🇺🇸
Nucleus Network, Saint Paul, Minnesota, United States
🇺🇸
The American Research Corporation, San Antonio, Texas, United States

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Phase 3

Completed

Conditions: Familial Hypercholesterolemia
Dyslipidemias
High Cholesterol
Hypercholesterolemia
ASCVD

Interventions: Combination Product: Combination Therapy
Drug: Monotherapy obicetrapib
Drug: Monotherapy ezetimibe
Other: Obicetrapib Placebo
Other: Combination Therapy placebo
Other: Ezetimibe Placebo

First Posted Date: 2023-08-22

Last Posted Date: 2024-11-08

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 407

Registration Number: NCT06005597

Locations: 🇺🇸
Progressive Medical Research, Port Orange, Florida, United States
🇺🇸
Centricity Research - Columbus, Columbus, Georgia, United States
🇺🇸
Center for Advanced Research and Education, Gainesville, Georgia, United States

and more 42 locations

Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

Phase 1

Active, not recruiting

Conditions: Lipid Metabolism

Interventions: Drug: Obicetrapib

First Posted Date: 2023-08-02

Last Posted Date: 2024-08-14

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 22

Registration Number: NCT05972278

Locations: 🇺🇸
Archna Bajaj, MD, Philadelphia, Pennsylvania, United States

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

Phase 3

Completed

Conditions: Dyslipidemias
Hyperlipoproteinemias
Familial Hypercholesterolemia
Lipid Metabolism Disorder
Metabolic Disease
Lipid Metabolism, Inborn Errors
Genetic Disease, Inborn
Hypercholesterolemia
High Cholesterol

Interventions: Drug: Placebo
Drug: Obicetrapib

First Posted Date: 2022-06-21

Last Posted Date: 2024-11-07

Lead Sponsor: NewAmsterdam Pharma

Target Recruit Count: 354

Registration Number: NCT05425745

Locations: 🇺🇸
Site 01015, Toluca Lake, California, United States
🇿🇦
Site 018004, Parow, South Africa
🇺🇸
Site 01009, Sarasota, Florida, United States

and more 93 locations

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