Delving into the Latest Updates on Obicetrapib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

AMG 899, AMG-899, DEZ 001

+ [2]

Target

CETP

Action

inhibitors

Mechanism

CETP inhibitors(Cholesteryl ester transfer protein inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [1]

Active Indication

Primary hypercholesterolemiaDiabetes Mellitus, Type 2Hyperlipidemias+ [6]

Inactive Indication

Alzheimer DiseaseHyperlipoproteinemias

Originator Organization

Tanabe Pharma Corp.

Active Organization

NewAmsterdam Pharma Holding BVNewAmsterdam Pharma Corp.NewAmsterdam Pharma Co. NV

+ [1]

Inactive Organization

License Organization

NewAmsterdam Pharma BV

+ [2]

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC32H31F9N4O5

InChIKeyNRWORBQAOQVYBJ-GJZUVCINSA-N

CAS Registry866399-87-3

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

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100 Translational Medicine associated with Obicetrapib

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100 Patents (Medical) associated with Obicetrapib

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51

Literatures (Medical) associated with Obicetrapib

01 Jul 2026·Medicina de Familia-SEMERGEN

Systematic review and meta-analysis on the safety and efficacy of obicetrapib combination therapy in dyslipidemia

Article

Author: Rab Nawaz, S ; Ibrahim Smeak, R ; Hammad Arif, M ; Andleeb, B ; Nawaz, M ; Waheed, N ; Timsina, G ; Hassan Zafar, M ; Ahmad, B ; Ahmad Khan, U

AIM:

To evaluate the efficacy of obicetrapib combination therapy group against the obicetrapib alone or placebo arm.

BACKGROUND:

Recently, the drug obicetrapib has been explored as a combination therapy with other lipid-lowering therapies as a treatment option for dyslipidemia, with the potential to affect atherogenic lipoproteins.

METHODS:

This review registered with PROSPERO (CRD420251112605) included adult patients with LDL-C levels greater than 70mg/dl. A comprehensive search strategy was developed on PubMed, Cochrane Central and ClinicalTrials.gov to identify randomized controlled trial (RCT's). For risk of bias assessment, ROB 2.0 tool was used. The mean difference (MD) and risk ratio (RR) were calculated via a random effects model using RStudio version 4.5.1.

RESULTS:

We identified six RCT's with a total of 657 patients. LDL-C, Apo-B, and non-HDL-C were notably reduced in the obicetrapib combination therapy group, with MDs of -44.14 (95% CI: -54.83, -33.45), -28.94 (95% CI: -37.50, -20.38), and -35.45 (95% CI: -48.46, -22.45), respectively. Moreover, HDL-C levels were improved in the combination therapy group, with an MD of 149.15 (95% CI: 136.88, 161.42). The incidence of adverse outcomes was reported to be insignificant.

CONCLUSION:

Our analysis revealed greater reductions in the levels of atherogenic lipoproteins, with obicetrapib combination therapies compared to placebo arm and obicetrapib monotherapy. A higher obicetrapib dosage (10mg), and combination with ezetimibe resulted in more reductions in lipoprotein levels. Although there is possibility for the effectiveness of obicetrapib combination therapies however due to high heterogeneity results needed to be interpreted with caution.

01 May 2026·Journal of Clinical Lipidology

Comparative efficacy and safety of obicetrapib vs bempedoic acid on top of statin therapy: A network meta-analysis

Article

Author: Marino, Gaetano ; Matteucci, Andrea ; Nardi, Federico ; Colivicchi, Furio ; Bonanni, Michela ; Fedele, Silvio ; Di Fusco, Stefania Angela

BACKGROUND:

Many patients receiving maximally tolerated statins fail to achieve recommended low-density lipoprotein cholesterol (LDL-C) levels, and multiple add-on nonstatin therapies are now available or in development, including obicetrapib and bempedoic acid. However, no direct comparison between these drugs is available.

OBJECTIVE:

We conducted a network meta-analysis of randomized, double-blind, placebo-controlled trials evaluating obicetrapib or bempedoic acid on top of statin therapy.

METHODS:

We conducted a network meta-analysis of randomized, double-blind, placebo-controlled trials evaluating obicetrapib or bempedoic acid on top of statin therapy. The primary outcome was the mean percentage change in LDL-C from baseline vs placebo. The secondary outcome was the mean percentage change in non-high-density lipoprotein cholesterol (non-HDL-C), treatment safety, including adverse events, serious adverse events, and cardiovascular composite endpoint. A random-effects model was used to synthesize evidence, test consistency, and generate treatment rankings. Heterogeneity and publication bias were also assessed.

RESULTS:

Six trials involving 6025 participants met the inclusion criteria. Obicetrapib resulted in a pooled LDL-C reduction of -33.17% (95% CI, -36.21 to -30.13) vs placebo, whereas bempedoic acid produced a reduction of -18.02% (95% CI, -18.83 to -17.21). The comparison of treatments showed an additional 15.15% in LDL-C reduction, favoring obicetrapib (95% CI, -18.30 to -12.00). There was no evidence of heterogeneity or inconsistency across the network (τ² = 0; I² = 0). Obicetrapib also showed a greater non-HDL-C reduction of -16.1% (95% CI, -19.1 to -13.1). Both drugs showed a comparable safety profile. Findings were consistent across multiple sensitivity analyses. No evidence of publication bias was detected.

CONCLUSION:

Among statin-treated patients requiring further LDL-C lowering, obicetrapib may represent an additional oral option to achieve the LDL-C target. Results should be interpreted in the context of currently available cardiovascular outcomes evidence, pending dedicated outcomes and long-term safety data.

29 Apr 2026·Current Atherosclerosis Reports

CETP Renaissance with Obicetrapib.

Review

Author: Catapano, Alberico L ; Pirillo, Angela

131

News (Medical) associated with Obicetrapib

28 May 2026

·www.globenewswire.com

NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in June

NAARDEN, the Netherlands and MIAMI, May 28, 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 that company management will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference 2026 in New York, NY on Wednesday, June 3, 2026. Michael Davidson, M.D., Chief Executive Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a fireside chat at 10:30 a.m. ET on Wednesday, June 3.Goldman Sachs 47th Annual Global Healthcare Conference in Miami Beach, FL on Tuesday, June 9, 2026. Michael Davidson, M.D., Chief Executive Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a fireside chat at 2:40 p.m. ET on Tuesday, June 9. Live webcasts of both presentations will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com. Following the live webcasts, archived replays will be available on the Company’s website. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactReal Chemistry on behalf of NewAmsterdamChristian EdgingtonP: 1-513-310-6410cedgington@realchemistry.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696austin.murtagh@precisionaq.com

Phase 3

28 May 2026

·www.biospace.com

NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in June 2026

NAARDEN, the Netherlands and MIAMI, May 28, 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 that company management will participate in the following upcoming investor conferences: Jefferies Global Healthcare Conference 2026 in New York, NY on Wednesday, June 3, 2026. Michael Davidson, M.D., Chief Executive Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a fireside chat at 10:30 a.m. ET on Wednesday, June 3. Goldman Sachs 47 th Annual Global Healthcare Conference in Miami Beach, FL on Tuesday, June 9, 2026. Michael Davidson, M.D., Chief Executive Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a fireside chat at 2:40 p.m. ET on Tuesday, June 9. Live webcasts of both presentations will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com . Following the live webcasts, archived replays will be available on the Company’s website. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. 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 3

11 May 2026

·www.globenewswire.com

NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in May

NAARDEN, the Netherlands and MIAMI, May 11, 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 that company management will participate in the following upcoming investor conferences: BofA Securities 2026 Health Care Conference in Las Vegas, NV on Tuesday, May 12, 2026. Ian Somaiya, Chief Financial Officer, BJ Jones, Chief Commercial Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a fireside chat at 5:15 p.m. PT on Tuesday, May 12.2026 RBCCM Global Healthcare Conference in New York, NY on Wednesday, May 20, 2026. Michael Davidson, M.D., Chief Executive Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a fireside chat at 2:05 p.m. ET on Wednesday, May 20. Live webcasts of both presentations will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com. Following the live webcasts, archived replays will be available on the Company’s website. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactReal Chemistry on behalf of NewAmsterdamChristian EdgingtonP: 1-513-310-6410cedgington@realchemistry.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696austin.murtagh@precisionaq.com

Phase 3

100 Deals associated with Obicetrapib

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14890

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary hypercholesterolemia	NDA/BLA	European Union	NewAmsterdam Pharma Co. NV	18 Aug 2025
Diabetes Mellitus, Type 2	Phase 3	United States	NewAmsterdam Pharma Corp.	11 Dec 2025
Hyperlipidemias	Phase 3	United States	NewAmsterdam Pharma Corp.	11 Dec 2025
Metabolic Syndrome	Phase 3	United States	NewAmsterdam Pharma Corp.	11 Dec 2025
Hyperlipoproteinemias	Phase 3	United States	NewAmsterdam Pharma Holding BV	25 Jul 2022
Hyperlipoproteinemias	Phase 3	Canada	NewAmsterdam Pharma Holding BV	25 Jul 2022
Hyperlipoproteinemias	Phase 3	Czechia	NewAmsterdam Pharma Holding BV	25 Jul 2022
Hyperlipoproteinemias	Phase 3	Netherlands	NewAmsterdam Pharma Holding BV	25 Jul 2022
Hyperlipoproteinemias	Phase 3	Norway	NewAmsterdam Pharma Holding BV	25 Jul 2022
Hyperlipoproteinemias	Phase 3	Poland	NewAmsterdam Pharma Holding BV	25 Jul 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05425745 (BROOKLYN, Pubmed \| Nat Med)	Phase 3	Heterozygous familial hypercholesterolemia	354	Obicetrapib 10 mg	dvodhbbjqt(jpoekvhgrf): 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)	suggbwtpdm(hxnodmfftq) = ldoyfrzepk xnglyqbpsn (wdpjahfwhz, 3.564) View more	-	08 Oct 2025
				Combination Therapy placebo+Monotherapy ezetimibe (Monotherapy Ezetimibe)	jalojffutg(ygyvouidsr) = jxoeawtjhs splcgzrsdj (zmgglxfjwb, 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	fbjclqfoje(yifwazwxxw) = lxldhrextq rgpoliansg (yagfkhtqsk ) View more	Positive	01 Oct 2025
				Placebo	fbjclqfoje(yifwazwxxw) = xanvvfqvke rgpoliansg (yagfkhtqsk ) View more
NCT05142722 (BROADWAY, CTgov)	Phase 3	Atherosclerosis \| Heterozygous familial hypercholesterolemia	2,530	Placebo (Placebo)	brdglgoaog(rfcgwsfqvp) = rbqjqpsovu botiyxxzwi (vvxbuifpkw, 1.571) View more	-	19 Sep 2025
				Obicetrapib (Obicetrapib 10mg)	brdglgoaog(rfcgwsfqvp) = bxtagwvjld botiyxxzwi (vvxbuifpkw, 1.104) View more
NCT05142722 \| NCT05425745 (BROADWAY, Literature) Manual	Not Applicable	Heterozygous familial hypercholesterolemia \| Atherosclerosis	2,884	Obicetrapib 10 mg	zaynrofsev(tsmclbbmrq) = mbmytajjbt qdataohkzi (itbsibascl ) View more	Positive	01 Sep 2025
				Placebo	zaynrofsev(tsmclbbmrq) = ivpulfghwo qdataohkzi (itbsibascl ) View more
NCT05142722 (BROADWAY, GlobeNewswire) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	1,515	Obicetrapib 10 mg	qlgxnkklya(thgvatyjqw): Difference (%) = -20.48, P-Value = 0.010 View more	Positive	30 Jul 2025
				Placebo
NCT05142722 (BROADWAY, Pubmed \| N Engl J Med \| NEWS) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	2,530	ObicetrapibObicetrapib 10 mg	jxhbmtpvrz(tfnhyfjurs) = zjovdwfyvb ekegjflrpx (ifvulhoanv, -32.1 to -27.8)	Positive	03 Jul 2025
				Placebo	jxhbmtpvrz(tfnhyfjurs) = yxfhmxtauc ekegjflrpx (ifvulhoanv, -0.4 to 5.8)
NCT05425745 (BROOKLYN, CTgov)	Phase 3	Hyperlipoproteinemias \| Heterozygous familial hypercholesterolemia	354	Placebo (Placebo)	lwxfwytzdb(ffebmefvdl) = fpukhnjtsh zwfkexhhnp (jeylkryife, 2.480) View more	-	11 Jun 2025
				Obicetrapib (Obicetrapib 10 mg)	lwxfwytzdb(ffebmefvdl) = osxluldpkq zwfkexhhnp (jeylkryife, 1.769) View more
NCT05142722 (BROADWAY, GlobeNewswire) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	-	Obicetrapib 10 mg	ahhobdgtwu(eevelptyjc) = imlkajoegn zdjqgrfijn (fvjpjvoabd ) View more	Positive	10 Dec 2024
				Placebo	ahhobdgtwu(eevelptyjc) = cakzeyrpea zdjqgrfijn (fvjpjvoabd ) View more
NCT06005597 (TANDEM, Company_Website) Manual	Phase 3	Heterozygous familial hypercholesterolemia \| Atherosclerosis	407	Placebo	scpdttnqaq(rhxnqzjddj) = bnyqivufvm yochahosom (gzvrgeubtz ) View more	Positive	20 Nov 2024
				Ezetimibe	scpdttnqaq(rhxnqzjddj) = wnomqqbcfo yochahosom (gzvrgeubtz ) View more