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NCT05425745CompletedPhase 3

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

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH Who Are Not Adequately Controlled by Their Lipid Modifying Therapies

Source: ClinicalTrials.gov · Last updated 11 Jun 2025

Brief summary (registry, in English)

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
354 (actual)
First submitted
15 Jun 2022
Start date
25 Jul 2022
Primary completion date
28 May 2024
Lead sponsor
NewAmsterdam Pharma
NCT number
NCT05425745

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 354
  • From 25 Jul 2022 to the primary completion date, 28 May 2024
  • 96 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Hospitalized for heart failure within 5 years prior to Screening
  • Major adverse cardiac event (MACE) within 3 months prior to Screening;
  • Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization

Lab values

  • New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction \< 30%;
  • HbA1c ≥10%, or fasting glucose

Other

  • Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)

Who the study is looking for

  • Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of \> 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
  • Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses
  • Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (96)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BramptonCanadaUnknown status
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ChicoutimiCanadaUnknown status
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HalifaxCanadaUnknown status
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MontrealCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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SherbrookeCanadaUnknown status
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VancouverCanadaUnknown status
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VictoriaCanadaUnknown status
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BrnoCzechiaUnknown status
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Hradec KrálovéCzechiaUnknown status
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PragueCzechiaUnknown status
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PragueCzechiaUnknown status
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PragueCzechiaUnknown status
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Uherské HradištěCzechiaUnknown status
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A CoruñaSpainUnknown status
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BarcelonaSpainUnknown status
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BarcelonaSpainUnknown status
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CórdobaSpainUnknown status
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FiguerasSpainUnknown status
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GranadaSpainUnknown status
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HuelvaSpainUnknown status
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HuescaSpainUnknown status
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Las Palmas de Gran CanariaSpainUnknown status
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MadridSpainUnknown status
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MadridSpainUnknown status
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MálagaSpainUnknown status
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SabadellSpainUnknown status
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Santiago de CompostelaSpainUnknown status
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SevilleSpainUnknown status
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SevilleSpainUnknown status
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ValenciaSpainUnknown status
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ZaragozaSpainUnknown status
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BirminghamUnited KingdomUnknown status
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BristolUnited KingdomUnknown status
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CardiffUnited KingdomUnknown status
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ChichesterUnited KingdomUnknown status
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DundeeUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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Metropolitan Borough of WirralUnited KingdomUnknown status
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PenzanceUnited KingdomUnknown status
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StevenageUnited KingdomUnknown status
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West BromwichUnited KingdomUnknown status
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BatumiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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AmsterdamNetherlandsUnknown status
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ArnhemNetherlandsUnknown status
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DeventerNetherlandsUnknown status
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EindhovenNetherlandsUnknown status
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RoosendaalNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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BodøNorwayUnknown status
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OsloNorwayUnknown status
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BialystokPolandUnknown status
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LodzPolandUnknown status
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LodzPolandUnknown status
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ZabrzePolandUnknown status
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ZamośćPolandUnknown status
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Baton RougeUnited StatesUnknown status
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BoiseUnited StatesUnknown status
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ChattanoogaUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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El PasoUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Iowa CityUnited StatesUnknown status
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JonesboroUnited StatesUnknown status
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LincolnUnited StatesUnknown status
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MorgantonUnited StatesUnknown status
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MorristownUnited StatesUnknown status
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New ProvidenceUnited StatesUnknown status
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NorfolkUnited StatesUnknown status
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North MassapequaUnited StatesUnknown status
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Port GibsonUnited StatesUnknown status
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SarasotaUnited StatesUnknown status
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St LouisUnited StatesUnknown status
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SuffolkUnited StatesUnknown status
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Toluca LakeUnited StatesUnknown status
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Winston-SalemUnited StatesUnknown status
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BloemfonteinSouth AfricaUnknown status
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Cape TownSouth AfricaUnknown status
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CenturionSouth AfricaUnknown status
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CenturionSouth AfricaUnknown status
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ParowSouth AfricaUnknown status
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Somerset WestSouth AfricaUnknown status
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Somerset WestSouth AfricaUnknown status
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TongaatSouth AfricaUnknown status
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UmhlangaSouth AfricaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.