Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
- Conditions
- DyslipidemiasHigh CholesterolHypercholesterolemiaFamilial HypercholesterolemiaAtherosclerotic Cardiovascular Disease
- Interventions
- Drug: PlaceboDrug: Obicetrapib
- Registration Number
- NCT05142722
- Lead Sponsor
- NewAmsterdam Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2532
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo one placebo tablet once daily obicetrapib 10mg Obicetrapib one 10mg obicetrapib tablet once daily
- Primary Outcome Measures
Name Time Method LDL-C Percent change from baseline to Day 84 in LDL-C obicetrapib compared to placebo on LDL-C
- Secondary Outcome Measures
Name Time Method LDL-C Percent change from baseline to Days 180 and 365 in LDL-C obicetrapib compared to placebo on LDL-C
apolipoprotein B (ApoB) Percent change from baseline to Day 84, Day 180, and Day 365 in ApoB obicetrapib compared to placebo on ApoB
non-HDL-C Percent change from baseline to Day 84, Day 180, and Day 365 in non-HDL-C obicetrapib compared to placebo on non-HDL-C
HDL-C Percent change from baseline to Day 84, Day 180, and Day 365 in HDL-C obicetrapib compared to placebo on HDL-C
Total Cholesterol Percent change from baseline to Day 84, Day 180, and Day 365 in TC obicetrapib compared to placebo on TC
Triglycerides Percent change from baseline to Day 84, Day 180, and Day 365 in TG obicetrapib compared to placebo on TG
Lipoprotein A [Lp(a)] Percent change from baseline to Day 84 in Lp(a) obicetrapib compared to placebo on Lp(a)
Apolipoprotein A1 (ApoA1) Percent change from baseline to Day 84 in ApoA1 obicetrapib compared to placebo on ApoA1
Trial Locations
- Locations (174)
New Generation of Medical Research
🇺🇸Hialeah, Florida, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Thyroid, Endocrinology & Diabetes, PA
🇺🇸Dallas, Texas, United States
Acad. G. Chapidze Emergency Cardiology Center LTD
🇬🇪Tbilisi, Georgia
Vitamedi LTD
🇬🇪Tbilisi, Georgia
Medi Club Georgia LLC
🇬🇪Tbilisi, Georgia
FutureMeds Warszawa Centrum
🇵🇱Warszawa, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
🇵🇱Wrocław, Poland
NZOZ Twoje Zdrowie EL Sp. z o.o.
🇵🇱Elblag, Poland
Silmedic Sp. z o.o.
🇵🇱Katowice, Poland
Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
🇵🇱Staszów, Poland
FutureMeds Sp. z o.o
🇵🇱Wrocław, Poland
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
The Center for Clinical Trials, Inc
🇺🇸Saraland, Alabama, United States
Clinical Research Institute of Arizona, LLC
🇺🇸Sun City West, Arizona, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Alta Pharmaceutical Research Center
🇺🇸Peachtree Corners, Georgia, United States
Orange County Research Center
🇺🇸Tustin, California, United States
East Coast Institute for Research, LLC
🇺🇸Macon, Georgia, United States
Tandem Clinical Research GI - Metairie
🇺🇸Metairie, Louisiana, United States
Cambridge Medical Trials
🇺🇸Alexandria, Louisiana, United States
Evanston Premier Healthcare Research LLC
🇺🇸Skokie, Illinois, United States
Northern Light Cardiology
🇺🇸Bangor, Maine, United States
Inspira Medical Centers dba Internal Medicine Associates, P.A.
🇺🇸Bridgeton, New Jersey, United States
Grace Research, LLC
🇺🇸Shreveport, Louisiana, United States
Biofortis, Inc
🇺🇸Addison, Illinois, United States
Southern Clinical Research, LLC
🇺🇸Zachary, Louisiana, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Privia Medical Group, LLC
🇺🇸Silver Spring, Maryland, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Diabetes and Endocrinology Consultants, P.C.
🇺🇸Morehead City, North Carolina, United States
Amarillo Heart Clinical Research Institute, Inc
🇺🇸Amarillo, Texas, United States
China-Japan Union Hospital Of Jilin University
🇨🇳Changchun, China
The Second People's Hospital of Changzhou
🇨🇳Changzhou, China
The First People's Hospital of Changde City
🇨🇳Changde, China
Affiliated Hospital of Chifeng University
🇨🇳Chifeng, China
Chifeng Municipal Hospital
🇨🇳Chifeng, China
Heilongjiang Provincial Hospital
🇨🇳Harbin, China
Tianjin Fourth Central Hospital
🇨🇳Tianjin, China
Wenzhou People's Hospital
🇨🇳Wenzhou, China
Tianjin People's Hospital
🇨🇳Tianjin, China
Xi'an Gaoxin Hospital
🇨🇳Xi'an, China
The Third Affiliatied Hospital of Xinxiang Medical University
🇨🇳Xinxiang, China
Zaozhuang Municipal Hospital
🇨🇳Zaozhuang, China
Xianyang Hospital of Yan 'an University
🇨🇳Xianyang, China
Centrum pro zdravi - kardiologie s.r.o.
🇨🇿Brno, Czechia
Cevni ambulance - MATMED s.r.o.
🇨🇿Hodonín, Czechia
KARDIOLOGIE - LIBEREC s.r.o.
🇨🇿Liberec, Czechia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Georgian-Ducht Hospital LTD
🇬🇪Tbilisi, Georgia
Sakurabashi Watanabe Hospital
🇯🇵Osaka, Japan
Health LTD
🇬🇪Batumi, Georgia
Adapti LTD
🇬🇪Tbilisi, Georgia
Canisius-Wilhelmina Ziekenhuis (CWZ)
🇳🇱Nijmegen, Netherlands
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Komatsu Municipal Hospital
🇯🇵Ishikawa, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
🇯🇵Hyōgo, Japan
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Tokyo Saiseikai Central Hospital
🇯🇵Tokyo, Japan
St. Jansdal Ziekenhuis
🇳🇱Harderwijk, Netherlands
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
CENTRUM MEDYCZNE INTERCOR Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Albert Schweitzer Ziekenhuis - Location Dordrecht
🇳🇱Zwijndrecht, Netherlands
KO - MED Centra Kliniczne Lublin II
🇵🇱Lublin, Poland
Ziekenhuis Deventer
🇳🇱Deventer, Netherlands
Slingeland Ziekenhuis
🇳🇱Doetinchem, Netherlands
Bravis ziekenhuis - Locatie Roosendaal
🇳🇱Roosendaal, Netherlands
Futuremeds Olsztyn
🇵🇱Olsztyn, Poland
Ziekenhuis Rijnstate
🇳🇱Arnhem, Netherlands
Reinier de Graaf Gasthuis
🇳🇱Delft, Netherlands
Laurentius Hospital Roermond
🇳🇱Roermond, Netherlands
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
VieCuri Medisch Centrum
🇳🇱Venlo, Netherlands
Gelre Ziekenhuizen - Locatie Zutphen
🇳🇱Zutphen, Netherlands
Centrum Medyczne Kermed - Renata Bijata-Bronisz I Ewa Kowalinska Spólka Jawna
🇵🇱Bydgoszcz, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Wlodzimierz Kus
🇵🇱Lodz, Poland
Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
🇵🇱Warszawa, Poland
FutureMeds Targowek
🇵🇱Warszawa, Poland
FutureMeds Lodz
🇵🇱Łódź, Poland
Public Central Hospital of Matto lshikawa
🇯🇵Ishikawa, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Japan
The Sakakibara Heart Institute of Okayama
🇯🇵Okayama, Japan
Syed Research Consultants, LLC
🇺🇸Sheffield, Alabama, United States
Mid Hudson Medical Research
🇺🇸New Windsor, New York, United States
CCR Czech a.s.
🇨🇿Pardubice, Czechia
Kardiologicka ambulance Brno s.r.o.
🇨🇿Brno, Czechia
CCR Ostrava s.r.o.
🇨🇿Ostrava, Czechia
Kardiologie COR s.r.o.
🇨🇿Prague, Czechia
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Synexus Clinical Research US, Inc. / Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Eclipse Clinical Research
🇺🇸Tucson, Arizona, United States
American Institute of Research
🇺🇸Beverly Hills, California, United States
Pioneer Clinical Studies
🇺🇸Fort Pierce, Florida, United States
Columbus Clinical Services, LLC
🇺🇸Miami, Florida, United States
East Coast Institute for Research- Lake City
🇺🇸Lake City, Florida, United States
East Coast Institute for Research, LLC - Jacksonville University Blvd
🇺🇸Jacksonville, Florida, United States
ClinCloud LLC
🇺🇸Maitland, Florida, United States
Kendall South Medical Center, Inc.
🇺🇸Miami, Florida, United States
East Coast Institute for Research
🇺🇸St. Augustine, Florida, United States
East Coast Institute for Research - Canton
🇺🇸Canton, Georgia, United States
Centricity Research
🇺🇸Columbus, Georgia, United States
SouthCoast Health
🇺🇸Savannah, Georgia, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Luoyang Third People's Hospital
🇨🇳Luoyang, China
Arcturus Healthcare, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Monument Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
Cardiovascular Research of Knoxville, LLC
🇺🇸Powell, Tennessee, United States
Summit Research Group, LLC
🇺🇸Stow, Ohio, United States
Javara Inc.
🇺🇸Conroe, Texas, United States
Prime Revival Research Institute, LLC
🇺🇸Coppell, Texas, United States
Northwest Houston Clinical Research
🇺🇸Tomball, Texas, United States
Hampton Roads Center for Clinical Research
🇺🇸Suffolk, Virginia, United States
Universal Research Group, LLC
🇺🇸Tacoma, Washington, United States
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Peking University First Hospital
🇨🇳Beijing, China
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Cangzhou Central Hospital
🇨🇳Cangzhou, China
Daqing People's Hospital
🇨🇳Daqing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Foshan First People's Hospital
🇨🇳Foshan, China
The Third Affiliated Hospital of Guangzhou Medical university
🇨🇳Guangzhou, China
The First Affiliated Hospital Of University Of South China
🇨🇳Hunan, China
Lishui Central Hospital
🇨🇳Lishui, China
Huabei Petroleum Administration Bureau General Hospital
🇨🇳Renqiu, China
Jinan Central Hospital
🇨🇳Jinan, China
Hebei Petro China Central Hospital
🇨🇳Langfang, China
Panjin Liaoyou Gem Flower Hospital
🇨🇳Panjin, China
The First affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, China
Hornicka nemocnice s poliklinikou Bilina s.r.o.
🇨🇿Bílina, Czechia
Medicus Services SRO
🇨🇿Brandýs Nad Labem, Czechia
MUDr. Tomas Edelsberger - diabetologicka ambulance
🇨🇿Krnov, Czechia
PreventaMed s.r.o.
🇨🇿Olomouc, Czechia
Amager Hospital
🇩🇰Copenhagen S, Denmark
Godstrup Regional Hospital (Gødstrup)
🇩🇰Herning, Denmark
Sydvestjysk Hospital
🇩🇰Esbjerg, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark
Bokhua Memorial Cardiovascular Center LTD
🇬🇪Tbilisi, Georgia
New Tokyo Heart Clinic
🇯🇵Chiba, Japan
The First Medical Center LTD
🇬🇪Tbilisi, Georgia
Chiba University Hospital
🇯🇵Chiba, Japan
Japan Community Health Care Organization Kyushu Hospital
🇯🇵Fukuoka, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Ishikawa, Japan
Showa University Northern Yokohama Hospital
🇯🇵Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Osaka, Japan
National Cerebral and Cardiovascular Center Research Institute
🇯🇵Osaka, Japan
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Academic Medical Center - Department of Vascular Medicine
🇳🇱Amsterdam, Netherlands
Tergooiziekenhuizen Blaricum
🇳🇱Blaricum, Netherlands
IJsselland ziekenhuis
🇳🇱Capelle Aan Den IJssel, Netherlands
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii, lek. med. Krzysztof Cymerman
🇵🇱Gdynia, Poland
Clinical Best Solutions - Lublin
🇵🇱Lublin, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Aka-Med Centrum Spólka Z Ograniczona Odpowiedzialnoscia
🇵🇱Ruda Slaska, Poland
JSC Curatio
🇬🇪Tbilisi, Georgia
Krakowskie Centrum Medyczne Sp. z o.o.
🇵🇱Kraków, Poland
Ostrowieckie Centrum Medyczne spólka cywilna Anna Olech-Cudzik
🇵🇱Ostrowiec Świętokrzyski, Poland
Prywatny Gabinet Lekarski Jacek Gessek
🇵🇱Torun, Poland
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PC
🇺🇸Birmingham, Alabama, United States
Synexus Clinical Research US, Inc.
🇺🇸Salt Lake City, Utah, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
🇺🇸Louisville, Kentucky, United States
Chear Center LLC
🇺🇸Bronx, New York, United States
Advanced Research Institute Inc
🇺🇸New Port Richey, Florida, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Apex Mobile Clinical Research
🇺🇸Bellaire, Texas, United States
Tandem Clinical Research GI, LLC
🇺🇸New York, New York, United States
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