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

  • STATUS
    Not Recruiting
  • days left to enroll
    20
  • participants needed
    2400
  • sponsor
    NewAmsterdam Pharma
Updated on 22 September 2023
diabetes
atorvastatin
fasting
type 2 diabetes mellitus
rosuvastatin
statin
hypercholesterolemia
ezetimibe
lipid-lowering therapy
hmg-coa reductase inhibitors
serum low density lipoprotein
pcsk9

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 an 365 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

Details
Condition Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Treatment Placebo, Obicetrapib
Clinical Study IdentifierNCT05142722
SponsorNewAmsterdam Pharma
Last Modified on22 September 2023

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