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

Last updated: November 6, 2024
Sponsor: NewAmsterdam Pharma
Overall Status: Completed

Phase

3

Condition

Dyslipidemia

Lysosomal Acid Lipase Deficiency (Lal)

Hypercholesterolemia

Treatment

Placebo

Obicetrapib

Clinical Study ID

NCT05425745
TA-8995-301
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteriawith a score of > 8 points; and/or Simon Broome Register Diagnostic Criteria fordefinite or possible Familial Hypercholesterolemia (FH)

  • Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screeningsuch as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9targeted therapy for at least 4 doses

  • Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)

Exclusion

Exclusion Criteria:

  • New York Heart Association class II or IV heart failure or last known leftventricular ejection fraction < 30%;

  • Hospitalized for heart failure within 5 years prior to Screening

  • Major adverse cardiac event (MACE) within 3 months prior to Screening;

  • HbA1c ≥10%, or fasting glucose

  • Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)

  • Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization

Study Design

Total Participants: 354
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 25, 2022
Estimated Completion Date:
May 28, 2024

Study Description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards, patients will be randomized to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.

Connect with a study center

  • Site 06007

    Brampton, L6Z 4N5
    Canada

    Site Not Available

  • Site 06008

    Chicoutimi, G7H 7K9
    Canada

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  • Site 06005

    Halifax, B3H 3A7
    Canada

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  • Site 06009

    Montreal, H3A 1A1
    Canada

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  • Site 06003

    Montréal, H2W 1R7
    Canada

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  • Site 06004

    Québec, G1V 4W2
    Canada

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  • Site 06006

    Sherbrooke, J1H 5N4
    Canada

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  • Site 06001

    Vancouver, V6Z 2C7
    Canada

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  • Site 06002

    Victoria, V8T 5G4
    Canada

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  • Site 02006

    Brno, 65691
    Czechia

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  • Site 02002

    Hradec Králové, 500 05
    Czechia

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  • Site 02003

    Praha, 128 08
    Czechia

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  • Site 02004

    Praha, 15006
    Czechia

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  • Site 02005

    Praha, 140 21
    Czechia

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  • Site 02001

    Uherské Hradiště, 686 01
    Czechia

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  • Site 022001

    Batumi, 6000
    Georgia

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  • Site 022002

    Tbilisi, 186
    Georgia

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  • Site 022003

    Tbilisi, 112
    Georgia

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  • Site 022004

    Tbilisi, 131
    Georgia

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  • Site 022005

    Tbilisi, 186
    Georgia

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  • Site 022006

    Tbilisi, 159
    Georgia

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  • Site 022007

    Tbilisi, 159
    Georgia

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  • Site 022008

    Tbilisi, 159
    Georgia

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  • Site 022009

    Tbilisi, 579
    Georgia

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  • Site 022010

    Tbilisi, 144
    Georgia

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  • Site 04001

    Amsterdam, 1105AZ
    Netherlands

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  • Site 04003

    Arnhem, 6815 AD
    Netherlands

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  • Site 04002

    Deventer, 7416 SE
    Netherlands

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  • Site 04004

    Eindhoven, 5631 BM
    Netherlands

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  • Site 04005

    Roosendaal, 4708 AE
    Netherlands

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    Rotterdam, 3015 GD
    Netherlands

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  • Site 023003

    Bodø, 8008
    Norway

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  • Site 023002

    Oslo, 587
    Norway

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  • Site 05002

    Białystok, 15-276
    Poland

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    Zabrze, 41-800
    Poland

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    Zamosc, 22-400
    Poland

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    Łódź, 92-213
    Poland

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    Łódź, 93-338
    Poland

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  • Site 018001

    Bloemfontein, 9301
    South Africa

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    Cape Town, 7530
    South Africa

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    Centurion, 157
    South Africa

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    Centurion, 154
    South Africa

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    Parow, 7500
    South Africa

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    Somerset West, 7130
    South Africa

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    Somerset West, 7130
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    Tongaat, 4400
    South Africa

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  • Site 018008

    Umhlanga, 4321
    South Africa

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  • Site 017001

    Barcelona, 8036
    Spain

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    Barcelona, 8907
    Spain

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    Córdoba, 14004
    Spain

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  • Site 17018

    Figueras, 17600
    Spain

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    Granada, 18014
    Spain

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    Huelva, 21007
    Spain

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    Huesca, 22002
    Spain

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  • Site 17004

    La Coruña, 15001
    Spain

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  • Site 17008

    Las Palmas De Gran Canaria, 35016
    Spain

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  • Site 17010

    Madrid, 28034
    Spain

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  • Site 17016

    Madrid, 28041
    Spain

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  • Site 17007

    Málaga, 29010
    Spain

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  • Site 17013

    Sabadell, 8208
    Spain

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  • Site 17015

    Santiago De Compostela, 15706
    Spain

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  • Site 17006

    Sevilla, 41013
    Spain

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  • Site 17009

    Sevilla, 41009
    Spain

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  • Site 17014

    Valencia, 46014
    Spain

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  • Site 17005

    Zaragoza, 50009
    Spain

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  • Site 014006

    Birmingham, B21 9RY
    United Kingdom

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  • Site 014012

    Bristol, BS2 8HW
    United Kingdom

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    Cardiff, CF14 4XW
    United Kingdom

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  • Site 014010

    Chichester, PO19 6SE
    United Kingdom

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  • Site 014001

    Dundee, DD1 9SY
    United Kingdom

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  • Site 014002

    London, NW3 2QG
    United Kingdom

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    Manchester, M23 9LT
    United Kingdom

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  • Site 014011

    Penzance, TR19 7HU
    United Kingdom

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  • Site 014005

    Stevenage, SG14AB
    United Kingdom

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  • Site 014004

    West Bromwich, B71 4HJ
    United Kingdom

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  • Site 014008

    Wirral, CH62 6EE
    United Kingdom

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  • Site 01022

    Jonesboro, Arkansas 72401
    United States

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  • Site 01015

    Toluca Lake, California 91602
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  • Site 01009

    Sarasota, Florida 34230
    United States

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  • Site 01023

    Boise, Idaho 83702
    United States

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  • Site 01018

    Chicago, Illinois 60602
    United States

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  • Site 01012

    Iowa City, Iowa 52240
    United States

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  • Site 01007

    Baton Rouge, Louisiana 70809
    United States

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  • Site 01005

    Port Gibson, Mississippi 39105
    United States

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  • Site 01006

    Saint Louis, Missouri 63130
    United States

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  • Site 01011

    Lincoln, Nebraska 68510
    United States

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  • Site 01004

    Norfolk, Nebraska 68701
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  • Site 01002

    Morristown, New Jersey 07960
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  • Site 01010

    New Providence, New Jersey 07901
    United States

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  • Site 01001

    North Massapequa, New York 11758
    United States

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  • Site 01020

    Morganton, North Carolina 28655
    United States

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  • Site 01019

    Winston-Salem, North Carolina 27157
    United States

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  • Site 01008

    Chattanooga, Tennessee 37405
    United States

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  • Site 01016

    El Paso, Texas 79905
    United States

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  • Site 01013

    Houston, Texas 76706
    United States

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  • Site 01014

    Suffolk, Virginia 23434
    United States

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