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NCT05142722 Clinical Trial

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

Hypercholesterolemia Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05142722
Other study ID # TA-8995-302
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 15, 2021
Est. completion date September 2024

Study information
Verified date September 2023
Source NewAmsterdam Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
placebo tablet made to resemble active
• Obicetrapib
10mg obicetrapib tablet
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Sponsors (1)
Lead Sponsor Collaborator
NewAmsterdam Pharma

Countries where clinical trial is conducted

United States,  China,  Czechia,  Denmark,  Georgia,  Japan,  Netherlands,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Other Major adverse cardiac event (MACE) evaluate the effect of obicetrapib on major adverse cardiac events Baseline to Day 400
Other Cardiovascular hospitalizations evaluate the effect of obicetrapib on cardiovascular hospitalizations Baseline to Day 400
Primary LDL-C obicetrapib compared to placebo on LDL-C Percent change from baseline to Day 84 in LDL-C
Secondary LDL-C obicetrapib compared to placebo on LDL-C Percent change from baseline to Days 180 and 365 in LDL-C
Secondary apolipoprotein B (ApoB) obicetrapib compared to placebo on ApoB Percent change from baseline to Day 84, Day 180, and Day 365 in ApoB
Secondary non-HDL-C obicetrapib compared to placebo on non-HDL-C Percent change from baseline to Day 84, Day 180, and Day 365 in non-HDL-C
Secondary HDL-C obicetrapib compared to placebo on HDL-C Percent change from baseline to Day 84, Day 180, and Day 365 in HDL-C
Secondary Total Cholesterol obicetrapib compared to placebo on TC Percent change from baseline to Day 84, Day 180, and Day 365 in TC
Secondary Triglycerides obicetrapib compared to placebo on TG Percent change from baseline to Day 84, Day 180, and Day 365 in TG
Secondary Lipoprotein A [Lp(a)] obicetrapib compared to placebo on Lp(a) Percent change from baseline to Day 84 in Lp(a)
Secondary Apolipoprotein A1 (ApoA1) obicetrapib compared to placebo on ApoA1 Percent change from baseline to Day 84 in ApoA1
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