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

Hypercholesterolemia Clinical Trial

— BROOKLYN  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05425745
• Other study ID #: TA-8995-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 25, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: NewAmsterdam Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

Description:

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Dyslipidemias
• Familial Hypercholesterolemia
• Genetic Disease, Inborn
• Genetic Diseases, Inborn
• High Cholesterol
• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemia Type II
• Hyperlipoproteinemias
• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Lipid Metabolism, Inborn Errors
• Metabolic Disease
• Metabolic Diseases
• Metabolism, Inborn Errors

Intervention

Drug:
• Obicetrapib
10 mg Obicetrapib tablet
• Placebo
placebo tablet made to resemble active

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NewAmsterdam Pharma

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Georgia,  Netherlands,  Norway,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

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)