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Trial record 1 of 1 for:    TA-8995-302
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Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY)

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ClinicalTrials.gov Identifier: NCT05142722
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
NewAmsterdam Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Dyslipidemias High Cholesterol Hypercholesterolemia Familial Hypercholesterolemia Atherosclerotic Cardiovascular Disease Drug: Placebo Drug: Obicetrapib Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-controlled, double-blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: placebo tablet made to resemble active
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
one placebo tablet once daily
Drug: Placebo
placebo tablet made to resemble active

Experimental: obicetrapib 10mg
one 10mg obicetrapib tablet once daily
Drug: Obicetrapib
10mg obicetrapib tablet




Primary Outcome Measures :
  1. LDL-C [ Time Frame: Percent change from baseline to Day 84 in LDL-C ]
    obicetrapib compared to placebo on LDL-C


Secondary Outcome Measures :
  1. apolipoprotein B (ApoB) [ Time Frame: Percent change from baseline to Day 84 in ApoB ]
    obicetrapib compared to placebo on ApoB

  2. non-HDL-C [ Time Frame: Percent change from baseline to Day 84 in non-HDL-C ]
    obicetrapib compared to placebo on non-HDL-C

  3. HDL-C [ Time Frame: Percent change from baseline to Day 84 in HDL-C ]
    obicetrapib compared to placebo on HDL-C

  4. Total Cholesterol [ Time Frame: Percent change from baseline to Day 84 in HDL-C ]
    obicetrapib compared to placebo on TC

  5. Triglycerides [ Time Frame: Percent change from baseline to Day 84 in TG ]
    obicetrapib compared to placebo on TG

  6. LDL-C [ Time Frame: Percent change from baseline to Day 180 in LDL-C ]
    obicetrapib compared to placebo on LDL-C

  7. LDL-C [ Time Frame: Percent change from baseline to Day 365 in LDL-C ]
    obicetrapib compared to placebo on LDL-C

  8. major adverse cardiac event (MACE) [ Time Frame: Baseline to end of study (30 days post last dose; approximately Day 395) ]
    evaluate the effect of obicetrapib on the risk of MACE



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, defined as follows:
  • maximally tolerated statin, at a stable dose for at least 4 weeks prior to Screening
  • Atorvastatin 40 or 80 mg; or
  • Rosuvastatin 20 or 40 mg;
  • Ezetimibe for at least 4 weeks prior to Screening
  • Bempedoic acid for at least 4 weeks prior to Screening
  • A PCSK-9 targeted therapy for at least 3 stable doses prior to Screening
  • A fibrate at a stable dose for at least 6 weeks prior to Screening (with the exception of gemfibrozil, which is not allowed); and / or
  • Statin intolerant participants and participants using a statin at a maximally tolerated stable dose may be on any of the following or combinations of ezetimibe, bempedoic acid, a PCSK9-targeted therapy, or a fibrate as defined in the previous bullets
  • Have a fasting serum LDL-C as follows:
  • Fasting serum LDL-C ≥70 and < 100 mg/dL (≥1.8 and <2.6 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;
  • 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
  • Fasting triglyceride (TG) < 400 mg/dL (<4.52 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 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;
  • 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% 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 Screening;
  • 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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142722


Contacts
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Contact: Jennifer Brown 513-579-9911 ext 12803 j.brown3@medpace.com

Locations
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Sponsors and Collaborators
NewAmsterdam Pharma
Investigators
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Study Director: Marc Ditmarsch NewAmsterdam Pharma
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Responsible Party: NewAmsterdam Pharma
ClinicalTrials.gov Identifier: NCT05142722    
Other Study ID Numbers: TA-8995-302
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NewAmsterdam Pharma:
obicetrapib
BROADWAY
Cholesteryl ester transfer protein (CETP) inhibitor
Heterozygous Familial Hypercholesterolemia (HeFH)
Atherosclerotic Cardiovascular Disease (ASCVD)
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Hyperlipoproteinemia Type II
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases