A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of Obicetrapib in Participants With Preclinical Alzheimer's Disease (SPINOZA Trial)

A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease

Start Date01 Sep 2026

Sponsor / Collaborator

NewAmsterdam Pharma Corp.

NCT07219602

/ Active, not recruitingPhase 3

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and 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 (RUBENS Trial)

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.

Start Date11 Dec 2025

Sponsor / Collaborator

NewAmsterdam Pharma Corp.

NCT06982508

/ RecruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled Parallel Trial to Assess the Effects of Obicetrapib on Levels of Antioxidants in Plasma and HDL Particles in Healthy Volunteers: The VERMEER Study

The goal of this clinical trial is to learn if Obicetrapib works to change antioxidant levels in HDL and plasma, as well as retinal tissue. The main questions it aims to answer are:
Do Obicetrapib effect absorption of antioxidants in a person's blood or their eye tissue? Researchers will compare Obicetrapib to a placebo (a look-alike substance that contains no drug) to see if Obicetrapib helps improve a person's ability to absorb antioxidants.
Participants will:
Take Obicetrapib or a placebo every day for 4 months Visit the clinic once every 8 weeks for checkups and tests Have their blood taken and their eyes checked to measure antioxidant levels

Start Date09 Sep 2025

Sponsor / Collaborator

MB Clinical Research & Consulting LLC

100 Clinical Results associated with Obicetrapib

100 Translational Medicine associated with Obicetrapib

100 Patents (Medical) associated with Obicetrapib

Literatures (Medical) associated with Obicetrapib

01 Jun 2026·American journal of preventive cardiology

Obicetrapib and renal function: A welcome signal, but not yet a kidney story

Author: Ray, Kausik K ; Barkas, Fotios

05 May 2026·Journal of the American Heart Association

From Failure to Promise: Obicetrapib and the Renaissance of Cholesteryl Ester Transfer Protein Inhibition in Atherosclerotic Cardiovascular Disease

Review

Author: Pradhan, Akshyaya ; Prajapathi, Sudesh ; Mohta, Aditi ; Mahajan, Kunal

Atherosclerotic cardiovascular diseases are a leading global cause of death, driven significantly by elevated low‐density lipoprotein cholesterol levels. Despite the emergence of effective lipid‐lowering therapies such as statins and other agents, a significant proportion of high‐risk patients fail to reach the recommended low‐density lipoprotein cholesterol targets. This highlights a critical unmet need for additional lipid‐lowering therapies that are not only efficacious and orally administered, but also demonstrate durable safety and cardiovascular benefits. CETP (cholesteryl ester transfer protein) inhibition alters lipid metabolism by preventing the transfer of cholesteryl esters from high‐density lipoprotein to apolipoprotein B–containing lipoproteins, thereby reducing atherogenic cholesterol burden. CETP inhibitors have had a challenging development history due to off‐target effects observed in early compounds like torcetrapib. However, obicetrapib is a highly selective and hydrophilic CETP inhibitor that heralds a promising new generation of drugs with robust lipid‐lowering capabilities and a favorable safety profile. This review presents a comprehensive overview of obicetrapib's mechanism of action, its pharmacokinetic and pharmacodynamic profiles, and a detailed critical assessment of its clinical development through various pivotal trials including TULIP (TA‐8995: Its Use in Patients With Mild Dyslipidemia), ROSE (Trial Evaluating Obicetrapib in Combination With Ezetimibe), ROSE2 (Phase 2b ROSE Trial Evaluating Obicetrapib in Combination With Ezetimibe), BROADWAY (Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid‐Modifying Therapies), BROOKLYN (Obicetrapib on Top of Maximum Tolerated Lipid‐Modifying Therapies, TANDEM (Study of Obicetrapib and Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid‐Modifying Therapies), and the ongoing PREVAIL (Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease) cardiovascular outcomes trial. We compare the efficacy, safety, and tolerability of obicetrapib against prevailing treatment options, positioning it as a potential oral adjunct to maximally tolerated lipid‐lowering regimens in the current lipid management landscape.

01 May 2026·NATURE MEDICINE

Author Correction: Obicetrapib in patients with heterozygous familial hypercholesterolemia: the BROOKLYN randomized clinical trial

Author: Ditmarsch, Marc ; Banach, Maciej ; Ray, Kausik K ; Goldberg, Anne C ; Nicholls, Stephen J ; Ference, Brian A ; Mehran, Roxana ; Davidson, Michael H ; Catapano, Alberico L ; Szarek, Michael ; Hsieh, Andrew ; Brunham, Liam R ; Neild, Annie L ; Nissen, Steven E ; Navar, Ann Marie ; Butters, Julie ; Laufs, Ulrich ; Nelson, Adam J ; Kastelein, John J P ; Ballantyne, Christie M ; Balinskaite, Violeta ; Kling, Douglas ; Wuerdeman, Erin

149

News (Medical) associated with Obicetrapib

29 Sep 2026

·www.biospace.com

NewAmsterdam Pharma Doses First Participant in Phase 2b SPINOZA Trial Evaluating Obicetrapib in Preclinical Alzheimer’s Disease

- SPINOZA is studying obicetrapib in adults with biomarker evidence suggestive of preclinical Alzheimer’s disease who do not have noticeable memory or functional symptoms- - The study will evaluate changes in blood-based biomarkers associated with Alzheimer’s disease, including p-tau 217, and additional cognitive and functional measures- NAARDEN, the Netherlands and MIAMI, Sept. 29, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the dosing of the first participant in SPINOZA, a Phase 2b clinical trial evaluating obicetrapib in individuals with preclinical Alzheimer’s disease. "The first participant dosed in SPINOZA marks an important milestone for NewAmsterdam as we expand the clinical evaluation of obicetrapib in Alzheimer's disease," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. "Alzheimer's disease pathology typically begins years before clinical symptom onset, creating an opportunity for intervention. The commencement of this trial is an important step in our effort to understand whether obicetrapib may affect biological changes associated with the disease before noticeable symptoms develop. The findings from our BROADWAY Alzheimer’s disease biomarker analysis, together with the growing body of evidence linking lipid metabolism to Alzheimer's disease pathology, provide a strong scientific rationale for further evaluating the effect of obicetrapib on biomarkers associated with disease progression and neurodegeneration." SPINOZA is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of obicetrapib in approximately 400 participants with preclinical Alzheimer's disease. Eligible participants have biomarker evidence consistent with early Alzheimer's disease pathology and carry ApoE4/E4, ApoE3/E4 or ApoE3/E3 genotypes. Participants will be randomized 1:1, stratified by genotype, to receive obicetrapib 10 mg or placebo for 52 weeks. Following completion of the double-blind treatment period, participants may enter a 26-week open-label extension study during which all participants will receive obicetrapib. The SPINOZA trial design was informed by findings from the prespecified Alzheimer’s disease biomarker analysis in the Company’s Phase 3 BROADWAY trial, which demonstrated the strongest observed biomarker response in ApoE4/E4 participants and supportive signals across additional genotype-defined populations. These findings informed the genotype-stratified design of SPINOZA and the selection of enrollment criteria intended to further evaluate the effects of obicetrapib on biomarkers associated with Alzheimer's disease pathology and neurodegeneration. SPINOZA further expands NewAmsterdam's clinical development program for obicetrapib alongside its ongoing Phase 3 REMBRANDT, RUBENS and PREVAIL clinical trials. People interested in learning more about the SPINOZA trial can visit spinoza.longboat.com . Additional eligibility criteria apply, and eligibility can only be determined by the study team following the required screening assessments. About Obicetrapib Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect pro to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About the Phase 2b SPINOZA Trial The SPINOZA trial is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study evaluating the effect of obicetrapib on plasma p-tau217 and other biomarkers associated with Alzheimer’s disease pathology and neurodegeneration in approximately 400 participants with preclinical Alzheimer's disease. Eligible participants are adults aged 55 to 85 years with preclinical Alzheimer's disease (Stage 1 or Stage 2) as defined by FDA guidance for Early Alzheimer's Disease drug development, a Mini-Mental State Examination (MMSE) score of at least 27, a global Clinical Dementia Rating (CDR) score of 0.5 or lower, and biomarker evidence of Alzheimer's disease pathology. Enrollment is restricted to participants with ApoE4/E4, ApoE3/E4, or ApoE3/E3 genotypes. Participants will be randomized 1:1 to receive obicetrapib 10 mg or placebo, stratified by genotype. The primary efficacy endpoint is change from baseline to Week 52 in plasma phosphorylated tau 217 (p-tau217), a biomarker associated with Alzheimer’s disease pathology. Secondary endpoints include changes in plasma Alzheimer's disease biomarkers, including Aβ42/Aβ40, p-tau217/Aβ42, p-tau217/Aβ42/40 and BD-tau, as well as change from baseline to Week 52 in the Preclinical Alzheimer's Cognitive Composite 5 (PACC5) score. Following completion of the 52-week double-blind treatment period, eligible participants may choose to enter an open-label extension lasting at least 26 weeks, during which all participants will receive obicetrapib. BROADWAY Alzheimer’s Analysis In BROADWAY, a pre-specified analysis was designed to assess plasma biomarkers of Alzheimer’s disease in patients enrolled in the BROADWAY trial and evaluated the effects of longer duration of therapy (12 months) with a prespecified ApoE population, based on phenotypic analysis. The analysis included 1,535 patients, including 367 ApoE4 carriers (ApoE3/E4 or ApoE4/E4), whose ApoE status was able to be determined. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), the AD analysis was not controlled for baseline differences between the treatment and placebo populations, but statistical analyses were adjusted for baseline biomarker values and age. The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, was measured among patients with baseline and end of study datapoints above the lower limit of quantitation. Additional outcome measures included NFL, GFAP, p-tau181, and Aβ42/40 ratio absolute and percent change over 12 months. NewAmsterdam observed statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set (p=0.025; n= 1,535) and in ApoE4 carriers (p=0.022; n=367) as well as favorable trends in the other AD biomarkers. Although a safety analysis was not performed in the AD analysis population, in BROADWAY obicetrapib was observed to be well-tolerated, with safety results comparable to placebo. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to building a new standard of care for people living with cardiometabolic and neurodegenerative diseases. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and are subject to the “safe harbor” provisions created thereunder. All statements that are not historical facts are hereby identified as forwarding-looking statements for this purposes and include, among others, statements relating to: the therapeutic potential of the Company’s product candidate; the design, progression, timing and objectives of the Company’s clinical trials, including the SPINOZA trial; and other statements regarding the Company's future operations, prospects, objectives, strategies and other future events. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon management’s current expectations and assumptions. Actual results or events could differ materially and adversely from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various risks, uncertainties and other factors, including, among others: uncertainties inherent in research and development, in the initiation and advancement of clinical trials and in the clinical development of obicetrapib in preclinical Alzheimer’s disease; whether results of early clinical trials and analyses will be indicative of the results of later clinical trials and analyses; risks to clinical trial site initiation, patient enrollment and follow-up; changes in domestic and foreign business, market, financial, political, and legal conditions; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 18, 2026 and in its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026, as well as in other filings the Company may make with the SEC in the future, which are available at Any forward-looking statements contained in this press release speak only as of the date of this press release, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of new information, future events, changed circumstances or otherwise, except as otherwise required by law. Company Contact Matthew Philippe P: 1-917-882-7512 matthew.philippe@newamsterdampharma.com Media Contact Real Chemistry on behalf of NewAmsterdam Christian Edgington P: 1-513-310-6410 cedgington@realchemistry.com Investor Contact Precision AQ on behalf of NewAmsterdam Austin Murtagh P: 1-212-698-8696 austin.murtagh@precisionaq.com

Phase 2Phase 3Clinical Result

23 Sep 2026

·www.globenewswire.com

NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)

- First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile- - First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment options for patients with elevated LDL-C - Sept. 21, 2026 -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, along with partner Menarini Group (“Menarini”), today announced that the European Commission (EC) has granted marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for patients with primary hypercholesterolaemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidaemia, marking the first regulatory approval of obicetrapib worldwide. "The European Commission approval of Ubeslo and Evlarco marks a major milestone for NewAmsterdam as the first regulatory approval of obicetrapib globally, a novel oral therapy, and validates years of work focused on delivering a potential new treatment option for patients who continue to struggle to achieve recommended LDL-C levels despite previously available therapies," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. "This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine. Together with Menarini, we look forward to bringing Ubeslo and Evlarco to patients across Europe and building on this important milestone as we advance our vision of making obicetrapib available to patients around the world." The European Commission approval follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is supported by data from NewAmsterdam's comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo. NewAmsterdam and Menarini continue to advance the clinical development of obicetrapib through multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial, as well as REMBRANDT and RUBENS. “This approval represents an important advancement for patients across Europe who require additional LDL-C lowering despite available therapies," said Elcin Barker Ergun, Chief Executive Officer of Menarini Group. "We are proud to reach this significant achievement alongside NewAmsterdam and look forward to leveraging our well-established commercial capabilities and deep cardiovascular expertise to bring Ubeslo and Evlarco to healthcare providers and eligible patients throughout Europe.” Under the parties' licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization activities throughout the region. NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones. Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of Major Adverse Cardiovascular Events (“MACE”). The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (“LLTs”). By 2050 more than 184 million U.S. adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased by 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated U.S. adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes. NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to build a new standard of care for people living with cardiometabolic disease. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose. The Menarini Group, with headquarters in Florence, is present in 140 countries worldwide to date, with $5.5 billion in consolidated turnover and more than 17,000 employees. Menarini’s products are present in the most important treatment areas, including those of cardiometabolic, oncology, gastroenterology, diabetology, pneumology, and anti-inflammatory/analgesic products. Through its commitment to R&D and high-quality manufacturing activities, Menarini continuously contributes to patients’ health worldwide, maintaining the highest quality standards. The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical ResultLicense out/inAHA

22 Sep 2026

·www.pharmaceutical-technology.com

EC approves Menarini and NewAmsterdam’s obicetrapib therapies

Obicetrapib is being developed as a low-dose, oral CETP inhibitor for lowering LDL cholesterol in patients unresponsive to treatments. Credit: PeopleImages / Shutterstock.com. The European Commission (EC) has granted marketing authorisation to NewAmsterdam Pharma and Menarini Group for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination). The authorisation allows both treatments to be used for patients with primary hypercholesterolaemia, including those with heterozygous familial and non-familial forms or mixed dyslipidaemia. This is said to be the first regulatory approval anywhere in the world for obicetrapib. The EC’s decision follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use. Backing for the approval comes from data in NewAmsterdam’s clinical development programme, including Phase III BROADWAY, BROOKLYN and TANDEM trials. Results from these studies showed statistically significant reductions in Low-density lipoprotein (LDL) cholesterol, with obicetrapib monotherapy reducing LDL-C by up to 40% compared to placebo, and the combination with ezetimibe reducing it by about 50%. The safety profile was reported as similar to placebo. Under the collaboration, Menarini holds exclusive rights to market obicetrapib in Europe and is responsible for regulatory and commercial activities there. NewAmsterdam will receive tiered double-digit royalties and could qualify for up to €833m in milestone-related payments. Both firms continue to evaluate obicetrapib in ongoing Phase III trials, including PREVAIL, REMBRANDT, and RUBENS. Obicetrapib is being developed as a low-dose, oral Cholesteryl ester transfer protein (CETP) inhibitor for lowering LDL cholesterol in patients who do not respond adequately to existing treatments. NewAmsterdam Pharma CEO Michael Davidson said: “The EC approval of Ubeslo and Evlarco marks a major milestone for NewAmsterdam as the first regulatory approval of obicetrapib globally, a novel oral therapy, and validates years of work focused on delivering a potential new treatment option for patients who continue to struggle to achieve recommended LDL-C levels despite previously available therapies. “This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine. “Together with Menarini, we look forward to bringing Ubeslo and Evlarco to patients across Europe and building on this important milestone as we advance our vision of making obicetrapib available to patients around the world.” In March 2025, the Menarini Group and its subsidiary Stemline Therapeutics announced a partnership with VisualDx to enhance the detection of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Phase 3Drug ApprovalClinical Result

100 Deals associated with Obicetrapib

External Link

KEGG	Wiki	ATC	Drug Bank
D12900	-	-	DB14890

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary hypercholesterolemia	European Union	NewAmsterdam Pharma Co. NV	21 Sep 2026
Primary hypercholesterolemia	Iceland	NewAmsterdam Pharma Co. NV	21 Sep 2026
Primary hypercholesterolemia	Liechtenstein	NewAmsterdam Pharma Co. NV	21 Sep 2026
Primary hypercholesterolemia	Norway	NewAmsterdam Pharma Co. NV	21 Sep 2026

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Complex dyslipidemia	NDA/BLA	European Union	Menarini International Operations Luxembourg SA	23 Jul 2026
Diabetes Mellitus, Type 2	Phase 3	United States	NewAmsterdam Pharma Corp.	11 Dec 2025
Diabetes Mellitus, Type 2	Phase 3	Czechia	NewAmsterdam Pharma Corp.	11 Dec 2025
Diabetes Mellitus, Type 2	Phase 3	Netherlands	NewAmsterdam Pharma Corp.	11 Dec 2025
Diabetes Mellitus, Type 2	Phase 3	Slovakia	NewAmsterdam Pharma Corp.	11 Dec 2025
Hyperlipidemias	Phase 3	United States	NewAmsterdam Pharma Corp.	11 Dec 2025
Hyperlipidemias	Phase 3	Czechia	NewAmsterdam Pharma Corp.	11 Dec 2025
Hyperlipidemias	Phase 3	Netherlands	NewAmsterdam Pharma Corp.	11 Dec 2025
Hyperlipidemias	Phase 3	Slovakia	NewAmsterdam Pharma Corp.	11 Dec 2025
Metabolic Syndrome	Phase 3	United States	NewAmsterdam Pharma Corp.	11 Dec 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05425745 (BROOKLYN, Pubmed \| Nat Med)	Phase 3	Heterozygous familial hypercholesterolemia	354	Obicetrapib 10 mg	rcakadevqg(vjrrrmuroz): Difference (%) = -36.3 (95.0% CI, -42.2 to -30.4), P-Value = < 0.0001	Positive	27 Feb 2026
				Placebo
NCT06005597 (TANDEM, CTgov)	Phase 3	Atherosclerosis \| Heterozygous familial hypercholesterolemia	407	Ezetimibe Placebo (Placebo)	spivyahtmt(wpsfboklgm) = cmtlhssueq numriqhpjf (itacppswbm, 3.564) View more	-	08 Oct 2025
				Combination Therapy placebo+Monotherapy ezetimibe (Monotherapy Ezetimibe)	iruancosnd(tdgtnyemid) = gqpyfffszq qzzwaitysf (stjqtvbsqz, 3.497) View more
NCT05142722 (BROADWAY, Pubmed \| J Prev Alzheimers Dis)	Phase 3	Cardiovascular Diseases p-tau217 \| p-tau217/Aβ42:40 \| GFAP ... View more	1,535	Obicetrapib 10 mg	amjeulnyaa(qrmhvexjvc) = kkazowurar mvyqkdryjk (qvmddlhrsv ) View more	Positive	01 Oct 2025
				Placebo	amjeulnyaa(qrmhvexjvc) = rhltdlrswo mvyqkdryjk (qvmddlhrsv ) View more
NCT05142722 (BROADWAY, CTgov)	Phase 3	Atherosclerosis \| Heterozygous familial hypercholesterolemia	2,530	Placebo (Placebo)	zzoxctbfrq(engrwxapuv) = yjrxhopppz sukrjrakjq (egvixezcjt, 1.571) View more	-	19 Sep 2025
				Obicetrapib (Obicetrapib 10mg)	zzoxctbfrq(engrwxapuv) = pyjgzpoyja sukrjrakjq (egvixezcjt, 1.104) View more
NCT05142722 \| NCT05425745 (BROADWAY, Literature) Manual	Not Applicable	Heterozygous familial hypercholesterolemia \| Atherosclerosis	2,884	Obicetrapib 10 mg	btlwqazato(mrfeloocuq) = lpybiswfok ojqrpjolhb (mrquwgnajb ) View more	Positive	01 Sep 2025
				Placebo	btlwqazato(mrfeloocuq) = bqsjwtgcrs ojqrpjolhb (mrquwgnajb ) View more
NCT05142722 (BROADWAY, GlobeNewswire) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	1,515	Obicetrapib 10 mg	heoeollvgq(kjqplmogwj): Difference (%) = -20.48, P-Value = 0.010 View more	Positive	30 Jul 2025
				Placebo
NCT05142722 (BROADWAY, AAIC2025)	Phase 3	Cardiovascular Diseases p-tau217 \| p-tau181 \| GFAP ... View more	1,727	Obicetrapib 10 mg	jypldvxcan(nrjsyxjyxh) = kklkqzbckr xgxcwibdgd (prbewlvfmv ) View more	Positive	27 Jul 2025
				Placebo	mjnanpjqkx(riiouqujkh) = mjsyillunk ttseolycmm (mlhwiodncv ) View more
NCT05142722 (BROADWAY, Pubmed \| N Engl J Med \| NEWS) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	2,530	ObicetrapibObicetrapib 10 mg	psflupqiom(pkmwanqxgc) = evyactaedv tedlllkebp (zeiwpeafmu, -32.1 to -27.8)	Positive	03 Jul 2025
				Placebo	psflupqiom(pkmwanqxgc) = znldrnayae tedlllkebp (zeiwpeafmu, -0.4 to 5.8)
NCT05425745 (BROOKLYN, CTgov)	Phase 3	Hyperlipoproteinemias \| Heterozygous familial hypercholesterolemia	354	Placebo (Placebo)	kemrcfipsc(owhqxadnaz) = kawwkzqcpu cnhrezjthy (wqvykwhgcq, 2.480) View more	-	11 Jun 2025
				Obicetrapib (Obicetrapib 10 mg)	kemrcfipsc(owhqxadnaz) = bahbdotywi cnhrezjthy (wqvykwhgcq, 1.769) View more
NCT05142722 (BROADWAY, GlobeNewswire) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	-	Obicetrapib 10 mg	sktqvyftgy(rpsqdsdgzx) = fnedjffqba cxmysahwtv (safvvsxfcw ) View more	Positive	10 Dec 2024
				Placebo	sktqvyftgy(rpsqdsdgzx) = sldzfjadau cxmysahwtv (safvvsxfcw ) View more

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