Clinical Trials
18
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
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Clinical Trials
Distribution across different clinical trial phases (18 trials with phase data)• Click on a phase to view related trials
Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers
- Conditions
- Antioxidant Absorption
- Interventions
- Drug: Placebo
- First Posted Date
- 2025-05-21
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- NewAmsterdam Pharma
- Target Recruit Count
- 100
- Registration Number
- NCT06982508
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
- 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
- Conditions
- Dyslipidemias
- Interventions
- 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 trial to test the effect of obicetrapib/ezetimibe on coronary plaque characteristics on coronary computerized tomography angiography in people with atherosclerotic cardiovascular disease
- Conditions
- Atherosclerotic Cardiovascular Disease
- First Posted Date
- 2024-07-22
- Last Posted Date
- 2025-01-14
- Lead Sponsor
- NewAmsterdam Pharma B.V.
- Target Recruit Count
- 250
- Registration Number
- 2023-508475-36-00
- Locations
- 🇮🇹
University Hospital Of Ferrara, Ferrara, Italy
🇮🇹Centro Cardiologico Monzino S.p.A., Milan, Italy
🇳🇱Medisch Centrum Leeuwarden B.V., Leeuwarden, Netherlands
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
- Conditions
- Healthy Volunteers
- Interventions
- 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
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News
NLS Pharmaceutics and NewAmsterdam Pharma File Mixed Securities Shelves Worth $75M and $500M Respectively
• NLS Pharmaceutics has filed a $75 million mixed securities shelf, signaling potential capital raising activities to support its clinical development pipeline in the near future. • NewAmsterdam Pharma has filed a significantly larger $500 million mixed securities shelf, positioning the company for substantial financing flexibility as it advances its cardiovascular therapeutics. • These strategic financial moves by both pharmaceutical companies indicate preparation for expanded research operations, clinical trials, or possible acquisitions in a competitive biotech funding landscape.
NewAmsterdam Pharma Advances Obicetrapib Program, Outlines 2025 Priorities
• NewAmsterdam Pharma reported positive Phase 3 results for obicetrapib, demonstrating significant LDL-C reduction and a favorable safety profile. • The company plans to present additional data from BROADWAY, BROOKLYN, and TANDEM trials throughout 2025 to support regulatory filings. • NewAmsterdam is focusing on commercial readiness, including scaling up manufacturing and building inventory for potential U.S. and European launches. • The company is also continuing Phase 2 and Phase 3 trials to evaluate obicetrapib's effects on lipoprotein(a) and coronary plaque, respectively.
Rilzabrutinib and Obicetrapib Show Promise in Phase 3 Trials, Bolstering Buy Ratings
Rilzabrutinib demonstrated a 65% platelet response rate in ITP patients in the Phase 3 LUNA 3 trial, compared to 33% in the placebo group, supporting its potential as a first-in-class treatment.
Sotatercept Shows Promise in Pulmonary Hypertension, Obicetrapib/Ezetimibe Lowers LDL-C
• Merck's sotatercept (Winrevair) met the primary endpoint in the Phase 3 ZENITH trial, demonstrating potential in treating pulmonary arterial hypertension. • A fixed-dose combination of obicetrapib and ezetimibe nearly halved LDL cholesterol in statin-resistant patients, according to NewAmsterdam Pharma. • Real-world data indicates improved outcomes with the Sapien 3 Ultra Resilia TAVR valve compared to older models, Edwards Lifesciences reported.
NewAmsterdam Pharma's Obicetrapib/Ezetimibe Combo Shows Promise in Phase 3 Trial
• NewAmsterdam Pharma's Phase 3 TANDEM trial reveals that a fixed-dose combination of obicetrapib and ezetimibe significantly reduces LDL-C levels in cardiovascular disease patients. • The trial met its primary endpoint, demonstrating a 50% reduction in LDL-C compared to placebo, with over 70% of patients achieving LDL-C levels below 55 mg/dL. • The combination treatment was well-tolerated, aligning with previous safety data, and is expected to support global regulatory filings for NewAmsterdam Pharma.
NewAmsterdam Pharma's Obicetrapib-Ezetimibe Combo Achieves LDL-C Endpoint in Phase III Trial
• NewAmsterdam Pharma's fixed-dose combination of obicetrapib and ezetimibe met its primary endpoint in a Phase III trial, demonstrating robust LDL-C reduction. • The study's consistent data supports the potential of the combination therapy for managing cholesterol levels in patients. • Despite positive results, investor concerns regarding specific findings led to a decrease in the company's stock price. • The CEO of NewAmsterdam Pharma emphasized the importance of outcomes, highlighting the clinical significance of the trial data.
Obicetrapib Shows Promise in Phase 3 BROADWAY Trial, Reduces LDL-C and MACE
NewAmsterdam Pharma's Obicetrapib significantly reduced LDL-C by 33% in patients with ASCVD and/or HeFH on maximally tolerated lipid-lowering therapies.
Obicetrapib Demonstrates Significant LDL-C Reduction in HeFH Patients in Phase III BROOKLYN Trial
• The Phase III BROOKLYN trial showed that obicetrapib, a CETP inhibitor, significantly reduced LDL cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH). • Obicetrapib achieved a placebo-adjusted LDL-C reduction of 41.5% at day 365, with 34% of patients experiencing a reduction greater than 50%. • The study also demonstrated improvements in other lipid parameters, including non-HDL cholesterol, apoB, HDL cholesterol, triglycerides, and Lp(a). • Obicetrapib was well-tolerated, with no significant changes in blood pressure, suggesting a potential advantage over previous CETP inhibitors.
Obicetrapib Shows Promise in Lowering LDL Cholesterol and Lp(a) in HeFH Patients
• Phase III BROOKLYN trial results show obicetrapib significantly reduces LDL cholesterol in patients with heterozygous familial hypercholesterolemia (HeFH). • The study demonstrated a 41.5% placebo-adjusted reduction in LDL cholesterol at day 365 and a 54.3% reduction in Lp(a) with obicetrapib. • Obicetrapib was well-tolerated, with no significant changes in blood pressure, addressing a concern with previous CETP inhibitors. • Analysts predict obicetrapib could reach $1.4 billion in sales by 2032, highlighting its potential in addressing unmet needs in dyslipidemia.
Obicetrapib Shows Sustained LDL-C Reduction in HeFH Patients in Phase 3 Trial
• Obicetrapib demonstrated a 36.3% reduction in LDL-C compared to placebo at day 84, which was sustained at 41.5% at day 365 in HeFH patients. • The BROOKLYN trial also showed a significant reduction in lipoprotein(a) by 45.9% at day 84 compared to placebo in patients with HeFH. • NewAmsterdam Pharma's obicetrapib exhibited a safety profile comparable to placebo in the Phase 3 BROOKLYN trial, with good tolerability. • The study results support obicetrapib's potential as a novel, oral therapy for managing LDL-C and other CVD risk factors in HeFH patients.