Hypercholesterolemia Clinical Trial
— BROOKLYNOfficial title:
A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH Who Are Not Adequately Controlled by Their Lipid Modifying Therapies
| Verified date | January 2024 |
| Source | NewAmsterdam Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
| Status | Active, not recruiting |
| Enrollment | 300 |
| Est. completion date | September 30, 2024 |
| Est. primary completion date | July 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of > 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH) - Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses - Fasting serum LDL-C =70 mg/dL (=1.80 mmol/L) 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; - HbA1c =10%, or fasting glucose - Formal diagnosis of homozygous familial hypercholesterolemia (HoFH) - Uncontrolled severe hypertension, defined as either systolic blood pressure = 160 mmHg or diastolic blood pressure =100 mmHg prior to Randomization |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Site 06007 | Brampton | |
| Canada | Site 06008 | Chicoutimi | |
| Canada | Site 06005 | Halifax | |
| Canada | Site 06009 | Montreal | |
| Canada | Site 06003 | Montréal | |
| Canada | Site 06004 | Québec | |
| Canada | Site 06006 | Sherbrooke | |
| Canada | Site 06001 | Vancouver | |
| Canada | Site 06002 | Victoria | |
| Czechia | Site 02006 | Brno | |
| Czechia | Site 02002 | Hradec Králové | |
| Czechia | Site 02003 | Praha | |
| Czechia | Site 02004 | Praha | |
| Czechia | Site 02005 | Praha | |
| Czechia | Site 02001 | Uherské Hradište | |
| Georgia | Site 022001 | Batumi | |
| Georgia | Site 022002 | Tbilisi | |
| Georgia | Site 022003 | Tbilisi | |
| Georgia | Site 022004 | Tbilisi | |
| Georgia | Site 022005 | Tbilisi | |
| Georgia | Site 022006 | Tbilisi | |
| Georgia | Site 022007 | Tbilisi | |
| Georgia | Site 022008 | Tbilisi | |
| Georgia | Site 022009 | Tbilisi | |
| Georgia | Site 022010 | Tbilisi | |
| Netherlands | Site 04001 | Amsterdam | |
| Netherlands | Site 04003 | Arnhem | |
| Netherlands | Site 04002 | Deventer | |
| Netherlands | Site 04004 | Eindhoven | |
| Netherlands | Site 04005 | Roosendaal | |
| Netherlands | Site 04006 | Rotterdam | |
| Norway | Site 023003 | Bodø | |
| Norway | Site 023002 | Oslo | |
| Poland | Site 05002 | Bialystok | |
| Poland | Site 05003 | Lódz | |
| Poland | Site 05004 | Lódz | |
| Poland | Site 05005 | Zabrze | |
| Poland | Site 05001 | Zamosc | |
| South Africa | Site 018001 | Bloemfontein | |
| South Africa | Site 018002 | Cape Town | |
| South Africa | Site 018006 | Centurion | |
| South Africa | Site 018009 | Centurion | |
| South Africa | Site 018004 | Parow | |
| South Africa | Site 018003 | Somerset West | |
| South Africa | Site 018005 | Somerset West | |
| South Africa | Site 018007 | Tongaat | |
| South Africa | Site 018008 | Umhlanga | |
| Spain | Site 017001 | Barcelona | |
| Spain | Site 17002 | Barcelona | |
| Spain | Site 17003 | Córdoba | |
| Spain | Site 17018 | Figueras | |
| Spain | Site 17011 | Granada | |
| Spain | Site 17017 | Huelva | |
| Spain | Site 17012 | Huesca | |
| Spain | Site 17004 | La Coruña | |
| Spain | Site 17008 | Las Palmas De Gran Canaria | |
| Spain | Site 17010 | Madrid | |
| Spain | Site 17016 | Madrid | |
| Spain | Site 17007 | Málaga | |
| Spain | Site 17013 | Sabadell | |
| Spain | Site 17015 | Santiago De Compostela | |
| Spain | Site 17006 | Sevilla | |
| Spain | Site 17009 | Sevilla | |
| Spain | Site 17014 | Valencia | |
| Spain | Site 17005 | Zaragoza | |
| United Kingdom | Site 014006 | Birmingham | |
| United Kingdom | Site 014012 | Bristol | |
| United Kingdom | Site 014009 | Cardiff | |
| United Kingdom | Site 014010 | Chichester | |
| United Kingdom | Site 014001 | Dundee | |
| United Kingdom | Site 014002 | London | |
| United Kingdom | Site 014003 | Manchester | |
| United Kingdom | Site 014011 | Penzance | |
| United Kingdom | Site 014005 | Stevenage | |
| United Kingdom | Site 014004 | West Bromwich | |
| United Kingdom | Site 014008 | Wirral | |
| United States | Site 01007 | Baton Rouge | Louisiana |
| United States | Site 01023 | Boise | Idaho |
| United States | Site 01008 | Chattanooga | Tennessee |
| United States | Site 01018 | Chicago | Illinois |
| United States | Site 01016 | El Paso | Texas |
| United States | Site 01013 | Houston | Texas |
| United States | Site 01012 | Iowa City | Iowa |
| United States | Site 01022 | Jonesboro | Arkansas |
| United States | Site 01011 | Lincoln | Nebraska |
| United States | Site 01020 | Morganton | North Carolina |
| United States | Site 01002 | Morristown | New Jersey |
| United States | Site 01010 | New Providence | New Jersey |
| United States | Site 01004 | Norfolk | Nebraska |
| United States | Site 01001 | North Massapequa | New York |
| United States | Site 01005 | Port Gibson | Mississippi |
| United States | Site 01006 | Saint Louis | Missouri |
| United States | Site 01009 | Sarasota | Florida |
| United States | Site 01014 | Suffolk | Virginia |
| United States | Site 01015 | Toluca Lake | California |
| United States | Site 01019 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| NewAmsterdam Pharma |
United States, Canada, Czechia, Georgia, Netherlands, Norway, Poland, South Africa, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Low Density Lipoprotein-Cholesterol (LDL-C) | Obicetrapib compared to placebo on Low Density Lipoprotein-Cholesterol (LDL-C) | Percent change from baseline to Day 84 in Low Density Lipoprotein-Cholesterol (LDL-C) | |
| Secondary | Apolipoprotein B (ApoB) | obicetrapib compared to placebo on ApoB | Percent change from baseline to Day 84, 180, and 365 in ApoB | |
| Secondary | non-HDL-C | obicetrapib compared to placebo on non-HDL-C | Percent change from baseline to Day 84, 180, and 364 in non-HDL-C | |
| Secondary | HDL-C | obicetrapib compared to placebo on HDL-C | Percent change from baseline to Day 84, 180, and 365 in HDL-C | |
| Secondary | Lp(a) | obicetrapib compared to placebo on Lp(a) | Percent change from baseline to Day 84 and 365 in Lp(a) | |
| Secondary | Total Cholesterol | obicetrapib compared to placebo on Total Cholesterol | Percent change from baseline to Day 84, 180, and 365 in Total Cholesterol | |
| Secondary | Triglycerides | obicetrapib compared to placebo on Triglycerides | Percent change from baseline to Day 84, 180, and 365 in Triglycerides | |
| Secondary | Low Density Lipoprotein-Cholesterol (LDL-C) | obicetrapib compared to placebo on Low Density Lipoprotein-Cholesterol (LDL-C) | Percent change from baseline to Day 180, and 365 in Low Density Lipoprotein-Cholesterol (LDL-C) |
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