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

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Hypercholesterolemia; Familial Hypercholesterolemia; Atherosclerotic Cardiovascular Disease; High Cholesterol
• Intervention / Treatment: Drug: Obicetrapib; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 2530
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Bengbu, China, 233017
    • The First Affiliated Hospital of Bengbu Medical College
  • Cangzhou, China, 61017
    • Cangzhou Central Hospital
  • Changchun, China, 130033
    • China-Japan Union Hospital of Jilin University
  • Changde, China, 415003
    • The First People's Hospital of Changde City
  • Changzhou, China, 213164
    • The Second People's Hospital of Changzhou
  • Chifeng, China, 24050
    • Affiliated Hospital of Chifeng University
  • Chifeng, China, 24099
    • Chifeng Municipal Hospital
  • Daqing, China, 163711
    • Daqing People's Hospital
  • Foshan, China, 528010
    • Foshan First People's Hospital
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510150
    • The Third Affiliated Hospital of Guangzhou Medical University
  • Harbin, China, 150036
    • Heilongjiang Provincial Hospital
  • Hunan, China, 421001
    • The First Affiliated Hospital of University of South China
  • Jinan, China, 250013
    • Jinan Central Hospital
  • Langfang, China, 65099
    • Hebei Petro China Central Hospital
  • Lishui, China, 323020
    • Lishui Central Hospital
  • Luoyang, China, 471002
    • Luoyang Third People's Hospital
  • Nanyang, China, 473024
    • The First Affiliated Hospital of Nanyang Medical College
  • Panjin, China, 124010
    • Panjin Liaoyou Gem Flower Hospital
  • Renqiu, China, 62550
    • Huabei Petroleum Administration Bureau General Hospital
  • Tianjin, China, 300121
    • Tianjin People's Hospital
  • Tianjin, China, 300143
    • Tianjin Fourth Central Hospital
  • Wenzhou, China, 325099
    • Wenzhou People's Hospital
  • Xi'an, China, 710075
    • Xi'an Gaoxin Hospital
  • Xianyang, China, 712099
    • Xianyang Hospital of Yan 'an University
  • Xinxiang, China, 453000
    • The Third Affiliatied Hospital of Xinxiang Medical University
  • Zaozhuang, China, 277102
    • Zaozhuang Municipal Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
• Czechia
  • Brandýs nad Labem, Czechia, 250 01
    • Medicus Services sro
  • Brno, Czechia, 612 00
    • Kardiologicka ambulance Brno s.r.o.
  • Brno, Czechia, 603 00
    • Centrum pro zdravi - kardiologie s.r.o.
  • Bílina, Czechia, 418 01
    • Hornicka nemocnice s poliklinikou Bilina s.r.o.
  • Hodonín, Czechia, 695 01
    • Cevni ambulance - MATMED s.r.o.
  • Krnov, Czechia, 794 01
    • MUDr. Tomas Edelsberger - diabetologicka ambulance
  • Liberec, Czechia, 46014
    • KARDIOLOGIE - LIBEREC s.r.o.
  • Olomouc, Czechia, 779 00
    • PreventaMed s.r.o.
  • Ostrava, Czechia, 702 00
    • CCR Ostrava s.r.o.
  • Pardubice, Czechia, 530 02
    • CCR Czech a.s.
  • Prague, Czechia, 106 00
    • Kardiologie COR s.r.o.
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen S, Denmark, 2300
    • Amager Hospital
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Hospital
  • Herning, Denmark, 7400
    • Godstrup Regional Hospital (Gødstrup)
  • Viborg, Denmark, 8800
    • Viborg Regional Hospital
• Georgia
  • Batumi, Georgia, 6004
    • Health LTD
  • Tbilisi, Georgia, 0114
    • JSC Curatio
  • Tbilisi, Georgia, 0160
    • Medi Club Georgia LLC
  • Tbilisi, Georgia, 0159
    • Acad. G. Chapidze Emergency Cardiology Center LTD
  • Tbilisi, Georgia, 0159
    • Bokhua Memorial CardioVascular Center LTD
  • Tbilisi, Georgia, 0159
    • Vitamedi LTD
  • Tbilisi, Georgia, 0172
    • Georgian-Ducht Hospital LTD
  • Tbilisi, Georgia, 0180
    • The First Medical Center LTD
  • Tbilisi, Georgia, 0186
    • Adapti LTD
• Japan
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Chiba, Japan, 271-0077
    • New Tokyo Heart Clinic
  • Fukuoka, Japan, 806-8501
    • Japan Community Health care Organization Kyushu Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hiroshima, Japan, 734-8530
    • Hiroshima Prefectural Hospital
  • Hyōgo, Japan, 670-8560
    • Hyogo Prefectural Harima-Himeji General Medical Center
  • Ishikawa, Japan, 920-8530
    • Ishikawa Prefectural Central Hospital
  • Ishikawa, Japan, 923-8560
    • Komatsu Municipal Hospital
  • Ishikawa, Japan, 924-8588
    • Public Central Hospital of Matto lshikawa
  • Kanagawa, Japan, 224-8503
    • Showa University Northern Yokohama Hospital
  • Kitakyushu, Japan, 802-8555
    • Kokura Memorial Hospital
  • Niigata, Japan, 951-8510
    • Niigata University Medical & Dental Hospital
  • Okayama, Japan, 700-0804
    • The Sakakibara Heart Institute of Okayama
  • Osaka, Japan, 530-0001
    • Sakurabashi Watanabe Hospital
  • Osaka, Japan, 565-8565
    • National Cerebral and Cardiovascular Center Research Institute
  • Osaka, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Tokyo, Japan, 108-0073
    • Tokyo Saiseikai Central Hospital
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis
  • Alkmaar, Netherlands, 1815 JD
    • Noordwest Ziekenhuisgroep
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center - Department of Vascular Medicine
  • Arnhem, Netherlands, 6815 AD
    • Ziekenhuis Rijnstate
  • Blaricum, Netherlands, 1261 AN
    • Tergooiziekenhuizen Blaricum
  • Capelle aan den IJssel, Netherlands, 2906 ZC
    • IJsselland Ziekenhuis
  • Delft, Netherlands, 2625 AD
    • Reinier de Graaf Gasthuis
  • Deventer, Netherlands, 7416 SE
    • Ziekenhuis Deventer
  • Doetinchem, Netherlands, 7009 BL
    • Slingeland Ziekenhuis
  • Groningen, Netherlands, 9728 NT
    • Martini Ziekenhuis
  • Harderwijk, Netherlands, 3844 DG
    • St. Jansdal Ziekenhuis
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelmina Ziekenhuis (CWZ)
  • Roermond, Netherlands, 6043 CV
    • Laurentius Hospital Roermond
  • Roosendaal, Netherlands, 4708 AE
    • Bravis ziekenhuis - Locatie Roosendaal
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
  • Venlo, Netherlands, 5912 BL
    • Viecuri Medisch Centrum
  • Zutphen, Netherlands, 7207 AE
    • Gelre Ziekenhuizen - Locatie Zutphen
  • Zwijndrecht, Netherlands, 3331 LZ
    • Albert Schweitzer Ziekenhuis - Location Dordrecht
• Poland
  • Bydgoszcz, Poland, 85-231
    • Centrum Medyczne Kermed - Renata Bijata-Bronisz i Ewa Kowalinska Spolka Jawna
  • Bydgoszcz, Poland, 85-605
    • Centrum Medyczne INTERCOR Sp. z o.o.
  • Elblag, Poland, 82-300
    • NZOZ Twoje Zdrowie EL Sp. z o.o.
  • Gdynia, Poland, 81-157
    • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
  • Katowice, Poland, 40-282
    • Silmedic Sp. z o.o.
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Lodz, Poland, 93-338
    • Instytut Centrum Zdrowia Matki Polki
  • Lodz, Poland, 94-255
    • Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
  • Lodz, Poland, 91-363
    • FutureMeds Lodz
  • Lublin, Poland, 20-078
    • Clinical Best Solutions - Lublin
  • Lublin, Poland, 20-362
    • KO - MED Centra Kliniczne Lublin II
  • Olsztyn, Poland, 10-010
    • FutureMeds Olsztyn
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik
  • Ruda Śląska, Poland, 41-710
    • Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia
  • Staszów, Poland, 28-200
    • Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
  • Torun, Poland, 87-100
    • Prywatny Gabinet Lekarski Jacek Gessek
  • Warsaw, Poland, 03-291
    • FutureMeds Targówek
  • Warsaw, Poland, 00-710
    • Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
  • Warsaw, Poland, 00-215
    • FutureMeds Warszawa Centrum
  • Wroclaw, Poland, 50-981
    • 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
  • Wroclaw, Poland, 50-088
    • Futuremeds sp. z o.o
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
    • Birmingham, Alabama, United States, 35211
      • Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC
    • Saraland, Alabama, United States, 36571
      • The Center for Clinical Trials, Inc
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants, LLC
  • Arizona
    • Sun City West, Arizona, United States, 85375
      • Clinical Research Institute of Arizona, LLC
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
    • Tucson, Arizona, United States, 85741
      • Synexus Clinical Research US, Inc. / Orange Grove Family Practice
  • California
    • Beverly Hills, California, United States, 90211
      • American Institute of Research
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • Vista, California, United States, 92083
      • Synexus Clinical Research US, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials
    • Ft. Pierce, Florida, United States, 34950
      • Pioneer Clinical Studies
    • Hialeah, Florida, United States, 33016
      • New Generation of Medical Research
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research, LLC
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research, LLC - Jacksonville University Blvd
    • Lake City, Florida, United States, 32055
      • East Coast Institute for Research- Lake City
    • Maitland, Florida, United States, 32751
      • ClinCloud LLC
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center, Inc.
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services, LLC
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute Inc
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute for Research
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research US, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research US, Inc.
    • Canton, Georgia, United States, 30114
      • East Coast Institute for Research - Canton
    • Columbus, Georgia, United States, 31904
      • Centricity Research
    • Macon, Georgia, United States, 31210
      • East Coast Institute for Research, LLC
    • Peachtree Corners, Georgia, United States, 30092
      • Alta Pharmaceutical Research Center
    • Savannah, Georgia, United States, 31406
      • Southcoast Health
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis, Inc
    • Skokie, Illinois, United States, 60077
      • Evanston Premier Healthcare Research LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Synexus Clinical Research US, Inc.
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Cambridge Medical Trials
    • Bossier City, Louisiana, United States, 71111
      • Grace Research, LLC
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
    • Metairie, Louisiana, United States, 70006
      • Tandem Clinical Research GI - Metairie
    • Shreveport, Louisiana, United States, 71105
      • Grace Research, LLC
    • Zachary, Louisiana, United States, 70791
      • Southern Clinical Research, LLC
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Cardiology
  • Maryland
    • Silver Spring, Maryland, United States, 20901
      • Privia Medical Group, LLC
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare, Troy Internal Medicine Research Division
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • AB Clinical Trials
  • New Jersey
    • Bridgeton, New Jersey, United States, 08302
      • Inspira Medical Centers dba Internal Medicine Associates, P.A.
  • New York
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research
    • New York, New York, United States, 10017
      • Synexus Clinical Research US, Inc.
    • New York, New York, United States, 10033
      • Tandem Clinical Research GI, LLC
    • The Bronx, New York, United States, 10455
      • CHEAR Center LLC
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Diabetes and Endocrinology Consultants, P.C.
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research, LLC
  • Ohio
    • Stow, Ohio, United States, 44224
      • Summit Research Group, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research
  • Tennessee
    • Powell, Tennessee, United States, 37849
      • Cardiovascular Research of Knoxville, LLC
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Heart Clinical Research Institute, Inc
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Bellaire, Texas, United States, 77401
      • Apex Mobile Clinical Research
    • Conroe, Texas, United States, 77384
      • Javara Inc.
    • Coppell, Texas, United States, 75019
      • Prime Revival Research Institute, LLC
    • Dallas, Texas, United States, 75208
      • Thyroid, Endocrinology & Diabetes, PA
    • Tomball, Texas, United States, 77375
      • Northwest Houston Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Synexus Clinical Research US, Inc.
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Suffolk, Virginia, United States, 23434
      • Hampton Roads Center for Clinical Research
  • Washington
    • Tacoma, Washington, United States, 98405
      • Universal Research Group, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; one placebo tablet once daily	Drug: Placebo; placebo tablet made to resemble active
Experimental: obicetrapib 10mg; one 10mg obicetrapib tablet once daily	Drug: Obicetrapib; 10mg obicetrapib tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]	LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).	84 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]	LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [Martin/Hopkins]. LDL-C value was calculated using the Martin/Hopkins equation unless TG >= 400 mg/dL or LDL-C <= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).	180 Days
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]	LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).	365 Days
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84	LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.	84 Days
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180	LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.	180 Days
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365	LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.	365 Days
Percent Change in Non-HDL-C From Baseline to Day 84	LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group.	84 Days
Percent Change in Non-HDL-C From Baseline to Day 180	LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.	180 Days
Percent Change in Non-HDL-C From Baseline to Day 365	LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.	365 Days
Percent Change in HDL-C From Baseline to Day 84	LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.	84 Days
Percent Change in HDL-C From Baseline to Day 180	LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.	180 Days
Percent Change in HDL-C From Baseline to Day 365	LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.	365 Days
Percent Change in Lp(a) From Baseline to Day 84	LS mean percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group.	84 Days
Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84	LS mean percent change from baseline to Day 84 in Apolipoprotein A1 (ApoA1) in obicetrapib group compared to the placebo group.	84 Days
Percent Change in Total Cholesterol From Baseline to Day 84	LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group.	84 Days
Percent Change in Total Cholesterol From Baseline to Day 180	LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group.	180 Days
Percent Change in Total Cholesterol From Baseline to Day 365	LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group.	365 Days
Percent Change in Triglycerides From Baseline to Day 84	LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group.	84 Days
Percent Change in Triglycerides From Baseline to Day 180	LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group.	180 Days
Percent Change in Triglycerides From Baseline to Day 365	LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group.	365 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac event (MACE)	evaluate the effect of obicetrapib on major adverse cardiac events	Baseline to Day 400
Cardiovascular hospitalizations	evaluate the effect of obicetrapib on cardiovascular hospitalizations	Baseline to Day 400

Collaborators and Investigators

• Sponsor: NewAmsterdam Pharma
• Investigators: Study Director: Marc Ditmarsch, NewAmsterdam Pharma

Publications and helpful links

General Publications

• Nicholls SJ, Nelson AJ, Ditmarsch M, Kastelein JJP, Ballantyne CM, Ray KK, Navar AM, Nissen SE, Goldberg AC, Brunham LR, Curcio D, Wuerdeman E, Neild A, Kling D, Hsieh A, Dicklin MR, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Davidson MH. Obicetrapib on top of maximally tolerated lipid-modifying therapies in participants with or at high risk for atherosclerotic cardiovascular disease: rationale and designs of BROADWAY and BROOKLYN. Am Heart J. 2024 Aug;274:32-45. doi: 10.1016/j.ahj.2024.05.002. Epub 2024 May 4.
• Nicholls SJ, Nelson AJ, Ditmarsch M, Kastelein JJP, Ballantyne CM, Ray KK, Navar AM, Nissen SE, Harada-Shiba M, Curcio DL, Neild A, Kling D, Hsieh A, Butters J, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Huo Y, Szarek M, Balinskaite V, Davidson MH; BROADWAY Investigators. Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk. N Engl J Med. 2025 Jul 3;393(1):51-61. doi: 10.1056/NEJMoa2415820. Epub 2025 May 7.

Helpful Links

• Study design paper
• Study primary results paper

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: obicetrapib; Atherosclerotic Cardiovascular Disease (ASCVD); BROADWAY; Cholesteryl ester transfer protein (CETP) inhibitor; Heterozygous Familial Hypercholesterolemia (HeFH)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hypercholesterolemia; Dyslipidemias; Hyperlipoproteinemia Type II; Atherosclerosis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: TA-8995-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No