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Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY)

Primary Purpose

Dyslipidemias, High Cholesterol, Hypercholesterolemia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Obicetrapib
Sponsored by
NewAmsterdam Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring obicetrapib, BROADWAY, Cholesteryl ester transfer protein (CETP) inhibitor, Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females may be enrolled if all 3 of the following criteria are met:
  • They are not pregnant;
  • They are not breastfeeding; and
  • They do not plan on becoming pregnant during the study;
  • Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD
  • Are on maximally tolerated lipid-modifying therapy, defined as follows:
  • maximally tolerated statin, at a stable dose for at least 4 weeks prior to Screening
  • Atorvastatin 40 or 80 mg; or
  • Rosuvastatin 20 or 40 mg;
  • Ezetimibe for at least 4 weeks prior to Screening
  • Bempedoic acid for at least 4 weeks prior to Screening
  • A PCSK-9 targeted therapy for at least 3 stable doses prior to Screening
  • A fibrate at a stable dose for at least 6 weeks prior to Screening (with the exception of gemfibrozil, which is not allowed); and / or
  • Statin intolerant participants and participants using a statin at a maximally tolerated stable dose may be on any of the following or combinations of ezetimibe, bempedoic acid, a PCSK9-targeted therapy, or a fibrate as defined in the previous bullets
  • Have a fasting serum LDL-C as follows:
  • Fasting serum LDL-C ≥70 and < 100 mg/dL (≥1.8 and <2.6 mmol/L) with at least 1 of the following risk enhancers at Screening;
  • Recent MI (> 3 and < 12 months prior to Randomization);
  • Type 2 diabetes mellitus;
  • Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L);
  • Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or
  • Fasting HDL-C < 40 mg/dL (<1.0 mmol/L); OR
  • Fasting serum LDL-C ≥ 100 mg/dL
  • Fasting triglyceride (TG) < 400 mg/dL (<4.52 mmol/L) at Screening; and
  • Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening

Exclusion Criteria:

  • New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction < 30%;
  • 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;
  • Formal diagnosis of homozygous familial hypercholesterolemia (HoFH);
  • Active liver disease;
  • HbA1c ≥10% at Screening;
  • Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN) at Screening;
  • Creatine kinase 3 X upper limit of normal (ULN) at Screening;
  • History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization;
  • Known history of alcohol and/or drug abuse within 5 years prior to Screening;
  • Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer;
  • Planned use of other investigational products or devices during the course of the study;
  • Participated in any clinical trial evaluating obicetrapib; or
  • Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
  • Any condition that, according to the Investigator, could interfere with the conduct of the study

Sites / Locations

  • Pinnacle Research Group
  • Central Alabama Research
  • Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC
  • The Center for Clinical Trials, Inc
  • Syed Research Consultants, LLC
  • Clinical Research Institute of Arizona, LLC
  • Synexus Clinical Research US, Inc. / Orange Grove Family Practice
  • Eclipse Clinical Research
  • American Institute of Research
  • Orange County Research Center
  • Synexus Clinical Research US, Inc.
  • Excel Medical Clinical Trials
  • Pioneer Clinical Studies
  • New Generation of Medical Research
  • East Coast Institute for Research, LLC
  • East Coast Institute for Research, LLC - Jacksonville University Blvd
  • East Coast Institute for Research- Lake City
  • ClinCloud LLC
  • Columbus Clinical Services, LLC
  • Kendall South Medical Center, Inc.
  • Advanced Research Institute Inc
  • Progressive Medical Research
  • East Coast Institute for Research
  • Synexus Clinical Research US, Inc.
  • Synexus Clinical Research US, Inc.
  • East Coast Institute for Research - Canton
  • Centricity Research
  • East Coast Institute for Research, LLC
  • Alta Pharmaceutical Research Center
  • SouthCoast Health
  • Biofortis, Inc
  • Evanston Premier Healthcare Research LLC
  • Synexus Clinical Research US, Inc.
  • Midwest Institute for Clinical Research
  • Cotton-O'Neil Clinical Research Center
  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
  • Research Integrity, LLC
  • Cambridge Medical Trials
  • Grace Research, LLC
  • Tandem Clinical Research
  • Tandem Clinical Research GI - Metairie
  • Grace Research, LLC
  • Southern Clinical Research, LLC
  • Northern Light Cardiology
  • Privia Medical Group, LLC
  • Oakland Medical Research
  • Arcturus Healthcare, Troy Internal Medicine Research Division
  • AB Clinical Trials
  • Inspira Medical Centers dba Internal Medicine Associates, P.A.
  • Chear Center LLC
  • Mid Hudson Medical Research
  • Synexus Clinical Research US, Inc.
  • Tandem Clinical Research GI, LLC
  • Diabetes and Endocrinology Consultants, P.C.
  • Lillestol Research, LLC
  • Summit Research Group, LLC
  • Monument Health Clinical Research
  • Cardiovascular Research of Knoxville, LLC
  • Amarillo Heart Clinical Research Institute, Inc
  • Inquest Clinical Research
  • Apex Mobile Clinical Research
  • Javara Inc.
  • Prime Revival Research Institute, LLC
  • Thyroid, Endocrinology & Diabetes, PA
  • Northwest Houston Clinical Research
  • Synexus Clinical Research US, Inc.
  • Manassas Clinical Research Center
  • Hampton Roads Center for Clinical Research
  • Universal Research Group, LLC
  • West China Hospital, Sichuan University
  • Peking University First Hospital
  • The First Affiliated Hospital of Bengbu Medical College
  • Cangzhou Central Hospital
  • China-Japan Union Hospital Of Jilin University
  • The First People's Hospital of Changde City
  • The Second People's Hospital of Changzhou
  • Affiliated Hospital of Chifeng University
  • Chifeng Municipal Hospital
  • Daqing People's Hospital
  • Foshan First People's Hospital
  • Guangdong Provincial People's Hospital
  • The Third Affiliated Hospital of Guangzhou Medical university
  • Heilongjiang Provincial Hospital
  • The First Affiliated Hospital Of University Of South China
  • Jinan Central Hospital
  • Hebei Petro China Central Hospital
  • Lishui Central Hospital
  • Luoyang Third People's Hospital
  • The First affiliated Hospital of Nanyang Medical College
  • Panjin Liaoyou Gem Flower Hospital
  • Huabei Petroleum Administration Bureau General Hospital
  • Tianjin People's Hospital
  • Tianjin Fourth Central Hospital
  • Wenzhou People's Hospital
  • Xi'an Gaoxin Hospital
  • Xianyang Hospital of Yan 'an University
  • The Third Affiliatied Hospital of Xinxiang Medical University
  • Zaozhuang Municipal Hospital
  • Medicus Services SRO
  • Centrum pro zdravi - kardiologie s.r.o.
  • Kardiologicka ambulance Brno s.r.o.
  • Hornicka nemocnice s poliklinikou Bilina s.r.o.
  • Cevni ambulance - MATMED s.r.o.
  • MUDr. Tomas Edelsberger - diabetologicka ambulance
  • KARDIOLOGIE - LIBEREC s.r.o.
  • PreventaMed s.r.o.
  • CCR Ostrava s.r.o.
  • CCR Czech a.s.
  • Kardiologie COR s.r.o.
  • Aarhus University Hospital
  • Amager Hospital
  • Sydvestjysk Hospital
  • Godstrup Regional Hospital (Gødstrup)
  • Viborg Regional Hospital
  • Health LTD
  • JSC Curatio
  • Acad. G. Chapidze Emergency Cardiology Center LTD
  • Bokhua Memorial Cardiovascular Center LTD
  • Vitamedi LTD
  • Medi Club Georgia LLC
  • Georgian-Ducht Hospital LTD
  • The First Medical Center LTD
  • Adapti LTD
  • Chiba University Hospital
  • New Tokyo Heart Clinic
  • Japan Community Health Care Organization Kyushu Hospital
  • Hiroshima Prefectural Hospital
  • Hiroshima University Hospital
  • Hyogo Prefectural Harima-Himeji General Medical Center
  • Ishikawa Prefectural Central Hospital
  • Komatsu Municipal Hospital
  • Public Central Hospital of Matto lshikawa
  • Showa University Northern Yokohama Hospital
  • Kokura Memorial Hospital
  • Niigata University Medical & Dental Hospital
  • The Sakakibara Heart Institute of Okayama
  • Sakurabashi Watanabe Hospital
  • National Cerebral and Cardiovascular Center Research Institute
  • Osaka Medical and Pharmaceutical University Hospital
  • Tokyo Saiseikai Central Hospital
  • Jeroen Bosch Ziekenhuis
  • Noordwest Ziekenhuisgroep
  • Onze Lieve Vrouwe Gasthuis
  • Academic Medical Center - Department of Vascular Medicine
  • Ziekenhuis Rijnstate
  • Tergooiziekenhuizen Blaricum
  • IJsselland ziekenhuis
  • Reinier de Graaf Gasthuis
  • Ziekenhuis Deventer
  • Slingeland Ziekenhuis
  • Martini Ziekenhuis
  • St. Jansdal Ziekenhuis
  • Canisius-Wilhelmina Ziekenhuis (CWZ)
  • Laurentius Hospital Roermond
  • Bravis ziekenhuis - Locatie Roosendaal
  • Ikazia Ziekenhuis
  • Universitair Medisch Centrum Utrecht
  • VieCuri Medisch Centrum
  • Gelre Ziekenhuizen - Locatie Zutphen
  • Albert Schweitzer Ziekenhuis - Location Dordrecht
  • Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna
  • CENTRUM MEDYCZNE INTERCOR Sp. z o.o.
  • NZOZ Twoje Zdrowie EL Sp. z o.o.
  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
  • Silmedic Sp. z o.o.
  • Krakowskie Centrum Medyczne Sp. z o.o.
  • Instytut Centrum Zdrowia Matki Polki
  • Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
  • Clinical Best Solutions - Lublin
  • KO - MED Centra Kliniczne Lublin II
  • Futuremeds Olsztyn
  • Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik
  • Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia
  • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
  • Prywatny Gabinet Lekarski Jacek Gessek
  • FutureMeds Warszawa Centrum
  • Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
  • FutureMeds Targowek
  • FutureMeds Sp. z o.o
  • 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
  • FutureMeds Lodz

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

obicetrapib 10mg

Arm Description

one placebo tablet once daily

one 10mg obicetrapib tablet once daily

Outcomes

Primary Outcome Measures

LDL-C
obicetrapib compared to placebo on LDL-C

Secondary Outcome Measures

LDL-C
obicetrapib compared to placebo on LDL-C
apolipoprotein B (ApoB)
obicetrapib compared to placebo on ApoB
non-HDL-C
obicetrapib compared to placebo on non-HDL-C
HDL-C
obicetrapib compared to placebo on HDL-C
Total Cholesterol
obicetrapib compared to placebo on TC
Triglycerides
obicetrapib compared to placebo on TG
Lipoprotein A [Lp(a)]
obicetrapib compared to placebo on Lp(a)
Apolipoprotein A1 (ApoA1)
obicetrapib compared to placebo on ApoA1

Full Information

First Posted
November 18, 2021
Last Updated
September 15, 2023
Sponsor
NewAmsterdam Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05142722
Brief Title
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
Acronym
BROADWAY
Official Title
A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewAmsterdam Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy
Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying HeFH and/or ASCVD 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 28 days. Afterwards patients will be randomized to placebo or 10 mg obicetrapib for a 365 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Keywords
obicetrapib, BROADWAY, Cholesteryl ester transfer protein (CETP) inhibitor, Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled, double-blind, randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
placebo tablet made to resemble active
Allocation
Randomized
Enrollment
2532 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one placebo tablet once daily
Arm Title
obicetrapib 10mg
Arm Type
Experimental
Arm Description
one 10mg obicetrapib tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablet made to resemble active
Intervention Type
Drug
Intervention Name(s)
Obicetrapib
Intervention Description
10mg obicetrapib tablet
Primary Outcome Measure Information:
Title
LDL-C
Description
obicetrapib compared to placebo on LDL-C
Time Frame
Percent change from baseline to Day 84 in LDL-C
Secondary Outcome Measure Information:
Title
LDL-C
Description
obicetrapib compared to placebo on LDL-C
Time Frame
Percent change from baseline to Days 180 and 365 in LDL-C
Title
apolipoprotein B (ApoB)
Description
obicetrapib compared to placebo on ApoB
Time Frame
Percent change from baseline to Day 84, Day 180, and Day 365 in ApoB
Title
non-HDL-C
Description
obicetrapib compared to placebo on non-HDL-C
Time Frame
Percent change from baseline to Day 84, Day 180, and Day 365 in non-HDL-C
Title
HDL-C
Description
obicetrapib compared to placebo on HDL-C
Time Frame
Percent change from baseline to Day 84, Day 180, and Day 365 in HDL-C
Title
Total Cholesterol
Description
obicetrapib compared to placebo on TC
Time Frame
Percent change from baseline to Day 84, Day 180, and Day 365 in TC
Title
Triglycerides
Description
obicetrapib compared to placebo on TG
Time Frame
Percent change from baseline to Day 84, Day 180, and Day 365 in TG
Title
Lipoprotein A [Lp(a)]
Description
obicetrapib compared to placebo on Lp(a)
Time Frame
Percent change from baseline to Day 84 in Lp(a)
Title
Apolipoprotein A1 (ApoA1)
Description
obicetrapib compared to placebo on ApoA1
Time Frame
Percent change from baseline to Day 84 in ApoA1
Other Pre-specified Outcome Measures:
Title
Major adverse cardiac event (MACE)
Description
evaluate the effect of obicetrapib on major adverse cardiac events
Time Frame
Baseline to Day 400
Title
Cardiovascular hospitalizations
Description
evaluate the effect of obicetrapib on cardiovascular hospitalizations
Time Frame
Baseline to Day 400

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females may be enrolled if all 3 of the following criteria are met: They are not pregnant; They are not breastfeeding; and They do not plan on becoming pregnant during the study; Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows: A statin at a maximally tolerated stable dose for at least 8 weeks prior to Screening Atorvastatin 40 and 80 mg; and Rosuvastatin 20 and 40 mg; Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening Have a fasting serum LDL-C at Screening as follows: Fasting serum LDL-C ≥ 55 to < 100 mg/dL (≥1.4 to <2.6 mmol/L) OR non-HDL-C ≥85 mg/dL (≥2.2 mmol/L) to < 130 mg/dL (<3.4 mmol/L) with at least 1 of the following risk enhancers at Screening; Recent MI (> 3 and < 12 months prior to Randomization); Type 2 diabetes mellitus; Current daily cigarette smoking; Age of > 60 years; High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L (≥19.0 nmol/L) at Screening or within 6 months prior to Screening Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L); Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or Fasting HDL-C < 40 mg/dL (<1.0 mmol/L); OR Fasting serum LDL-C ≥ 100 mg/dL (≥2.6 mmol/L) or non-HDL-C ≥130 mg/dL (≥3.4 mmol/L) Fasting triglyceride (TG) < 500 mg/dL (<5.7 mmol/L) at Screening; and Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening Exclusion Criteria: New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%; 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; Formal diagnosis of homozygous familial hypercholesterolemia (HoFH); Active liver disease; HbA1c ≥10% or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening; Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN) at Screening; Creatine kinase > 3 X upper limit of normal (ULN) at Screening; History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization; Known history of alcohol and/or drug abuse within 5 years prior to Randomization Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer; Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening Planned use of other investigational products or devices during the course of the study; Participated in any clinical trial evaluating obicetrapib; or Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo Any condition that, according to the Investigator, could interfere with the conduct of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ditmarsch
Organizational Affiliation
NewAmsterdam Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
The Center for Clinical Trials, Inc
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Syed Research Consultants, LLC
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Clinical Research Institute of Arizona, LLC
City
Sun City West
State/Province
Arizona
ZIP/Postal Code
85375
Country
United States
Facility Name
Synexus Clinical Research US, Inc. / Orange Grove Family Practice
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Eclipse Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
American Institute of Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Pioneer Clinical Studies
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
New Generation of Medical Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
East Coast Institute for Research, LLC - Jacksonville University Blvd
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
East Coast Institute for Research- Lake City
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
ClinCloud LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Columbus Clinical Services, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Advanced Research Institute Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
East Coast Institute for Research
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
East Coast Institute for Research - Canton
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Alta Pharmaceutical Research Center
City
Peachtree Corners
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Facility Name
SouthCoast Health
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Biofortis, Inc
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Cambridge Medical Trials
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Grace Research, LLC
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Tandem Clinical Research GI - Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Grace Research, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Southern Clinical Research, LLC
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Northern Light Cardiology
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Privia Medical Group, LLC
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
Facility Name
Oakland Medical Research
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Arcturus Healthcare, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Inspira Medical Centers dba Internal Medicine Associates, P.A.
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
Country
United States
Facility Name
Chear Center LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
Mid Hudson Medical Research
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Tandem Clinical Research GI, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
Diabetes and Endocrinology Consultants, P.C.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lillestol Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Summit Research Group, LLC
City
Stow
State/Province
Ohio
ZIP/Postal Code
44224
Country
United States
Facility Name
Monument Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Cardiovascular Research of Knoxville, LLC
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Facility Name
Amarillo Heart Clinical Research Institute, Inc
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Apex Mobile Clinical Research
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Javara Inc.
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Prime Revival Research Institute, LLC
City
Coppell
State/Province
Texas
ZIP/Postal Code
75019
Country
United States
Facility Name
Thyroid, Endocrinology & Diabetes, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Northwest Houston Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23434
Country
United States
Facility Name
Universal Research Group, LLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233017
Country
China
Facility Name
Cangzhou Central Hospital
City
Cangzhou
ZIP/Postal Code
61017
Country
China
Facility Name
China-Japan Union Hospital Of Jilin University
City
Changchun
ZIP/Postal Code
130033
Country
China
Facility Name
The First People's Hospital of Changde City
City
Changde
ZIP/Postal Code
415003
Country
China
Facility Name
The Second People's Hospital of Changzhou
City
Changzhou
ZIP/Postal Code
213164
Country
China
Facility Name
Affiliated Hospital of Chifeng University
City
Chifeng
ZIP/Postal Code
24050
Country
China
Facility Name
Chifeng Municipal Hospital
City
Chifeng
ZIP/Postal Code
24099
Country
China
Facility Name
Daqing People's Hospital
City
Daqing
ZIP/Postal Code
163711
Country
China
Facility Name
Foshan First People's Hospital
City
Foshan
ZIP/Postal Code
528010
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
The Third Affiliated Hospital of Guangzhou Medical university
City
Guangzhou
ZIP/Postal Code
510150
Country
China
Facility Name
Heilongjiang Provincial Hospital
City
Harbin
ZIP/Postal Code
150036
Country
China
Facility Name
The First Affiliated Hospital Of University Of South China
City
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Hebei Petro China Central Hospital
City
Langfang
ZIP/Postal Code
65099
Country
China
Facility Name
Lishui Central Hospital
City
Lishui
ZIP/Postal Code
323020
Country
China
Facility Name
Luoyang Third People's Hospital
City
Luoyang
ZIP/Postal Code
471002
Country
China
Facility Name
The First affiliated Hospital of Nanyang Medical College
City
Nanyang
ZIP/Postal Code
473024
Country
China
Facility Name
Panjin Liaoyou Gem Flower Hospital
City
Panjin
ZIP/Postal Code
124010
Country
China
Facility Name
Huabei Petroleum Administration Bureau General Hospital
City
Renqiu
ZIP/Postal Code
62550
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Tianjin Fourth Central Hospital
City
Tianjin
ZIP/Postal Code
300143
Country
China
Facility Name
Wenzhou People's Hospital
City
Wenzhou
ZIP/Postal Code
325099
Country
China
Facility Name
Xi'an Gaoxin Hospital
City
Xi'an
ZIP/Postal Code
710075
Country
China
Facility Name
Xianyang Hospital of Yan 'an University
City
Xianyang
ZIP/Postal Code
712099
Country
China
Facility Name
The Third Affiliatied Hospital of Xinxiang Medical University
City
Xinxiang
ZIP/Postal Code
453000
Country
China
Facility Name
Zaozhuang Municipal Hospital
City
Zaozhuang
ZIP/Postal Code
277102
Country
China
Facility Name
Medicus Services SRO
City
Brandýs Nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
Centrum pro zdravi - kardiologie s.r.o.
City
Brno
ZIP/Postal Code
603 00
Country
Czechia
Facility Name
Kardiologicka ambulance Brno s.r.o.
City
Brno
ZIP/Postal Code
612 00
Country
Czechia
Facility Name
Hornicka nemocnice s poliklinikou Bilina s.r.o.
City
Bílina
ZIP/Postal Code
418 01
Country
Czechia
Facility Name
Cevni ambulance - MATMED s.r.o.
City
Hodonín
ZIP/Postal Code
695 01
Country
Czechia
Facility Name
MUDr. Tomas Edelsberger - diabetologicka ambulance
City
Krnov
ZIP/Postal Code
794 01
Country
Czechia
Facility Name
KARDIOLOGIE - LIBEREC s.r.o.
City
Liberec
ZIP/Postal Code
46014
Country
Czechia
Facility Name
PreventaMed s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
CCR Ostrava s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
CCR Czech a.s.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Kardiologie COR s.r.o.
City
Prague
ZIP/Postal Code
106 00
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Amager Hospital
City
Copenhagen S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Sydvestjysk Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Godstrup Regional Hospital (Gødstrup)
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Health LTD
City
Batumi
ZIP/Postal Code
6004
Country
Georgia
Facility Name
JSC Curatio
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Acad. G. Chapidze Emergency Cardiology Center LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Bokhua Memorial Cardiovascular Center LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Vitamedi LTD
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Medi Club Georgia LLC
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Georgian-Ducht Hospital LTD
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
The First Medical Center LTD
City
Tbilisi
ZIP/Postal Code
0180
Country
Georgia
Facility Name
Adapti LTD
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
New Tokyo Heart Clinic
City
Chiba
ZIP/Postal Code
271-0077
Country
Japan
Facility Name
Japan Community Health Care Organization Kyushu Hospital
City
Fukuoka
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hyogo Prefectural Harima-Himeji General Medical Center
City
Hyōgo
ZIP/Postal Code
670-8560
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Komatsu Municipal Hospital
City
Ishikawa
ZIP/Postal Code
923-8560
Country
Japan
Facility Name
Public Central Hospital of Matto lshikawa
City
Ishikawa
ZIP/Postal Code
924-8588
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8510
Country
Japan
Facility Name
The Sakakibara Heart Institute of Okayama
City
Okayama
ZIP/Postal Code
700-0804
Country
Japan
Facility Name
Sakurabashi Watanabe Hospital
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center Research Institute
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Tokyo Saiseikai Central Hospital
City
Tokyo
ZIP/Postal Code
108-0073
Country
Japan
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Academic Medical Center - Department of Vascular Medicine
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Tergooiziekenhuizen Blaricum
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
IJsselland ziekenhuis
City
Capelle Aan Den IJssel
ZIP/Postal Code
2906 ZC
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Ziekenhuis Deventer
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
Slingeland Ziekenhuis
City
Doetinchem
ZIP/Postal Code
7009 BL
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
St. Jansdal Ziekenhuis
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis (CWZ)
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Laurentius Hospital Roermond
City
Roermond
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Bravis ziekenhuis - Locatie Roosendaal
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
VieCuri Medisch Centrum
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Gelre Ziekenhuizen - Locatie Zutphen
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis - Location Dordrecht
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
CENTRUM MEDYCZNE INTERCOR Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Facility Name
NZOZ Twoje Zdrowie EL Sp. z o.o.
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Facility Name
Silmedic Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
City
Lodz
ZIP/Postal Code
94-255
Country
Poland
Facility Name
Clinical Best Solutions - Lublin
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Facility Name
KO - MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Futuremeds Olsztyn
City
Olsztyn
ZIP/Postal Code
10-010
Country
Poland
Facility Name
Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia
City
Ruda Slaska
ZIP/Postal Code
41-710
Country
Poland
Facility Name
Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
City
Staszów
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Jacek Gessek
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
FutureMeds Warszawa Centrum
City
Warszawa
ZIP/Postal Code
00-215
Country
Poland
Facility Name
Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
City
Warszawa
ZIP/Postal Code
00-710
Country
Poland
Facility Name
FutureMeds Targowek
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
FutureMeds Sp. z o.o
City
Wrocław
ZIP/Postal Code
50-088
Country
Poland
Facility Name
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-981
Country
Poland
Facility Name
FutureMeds Lodz
City
Łódź
ZIP/Postal Code
91-363
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

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