The trial is taking place at:
P

Pinnacle Research Group | Anniston, AL

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

N

NewAmsterdam Pharma

Status and phase

Active, not recruiting
Phase 3

Conditions

Atherosclerotic Cardiovascular Disease
Dyslipidemias
Hypercholesterolemia
High Cholesterol
Familial Hypercholesterolemia

Treatments

Drug: Obicetrapib
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05142722
TA-8995-302

Details and patient eligibility

About

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

Full 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.

Enrollment

2,532 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2,532 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
one placebo tablet once daily
Treatment:
Drug: Placebo
obicetrapib 10mg
Experimental group
Description:
one 10mg obicetrapib tablet once daily
Treatment:
Drug: Obicetrapib

Trial contacts and locations

182

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Central trial contact

Jennifer Brown

Data sourced from clinicaltrials.gov

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