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

NCT05142722
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,530
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Lead sponsor
NewAmsterdam Pharma
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Start date
2021-12-15
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Number of sites
181
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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
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Acronym
BROADWAY
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Short title
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
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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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-09-26
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First posted
2021-12-03
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Registry last updated
2025-09-19
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Primary completion date
2024-09-26
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Start date
2021-12-15
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Actual participants
2,530
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Participants
2,530
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Participant count basis
Actual
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Protocol amendments
8
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Number of sites
181
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
NewAmsterdam Pharma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05142722
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ClinicalTrials.gov ID
NCT05142722
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
placebo tablet made to resemble active
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

  1. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]

    Timeframe: 180 Days

    LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[Martin/Hopkins\]. LDL-C value was calculated using the Martin/Hopkins equation unless TG \>= 400 mg/dL or LDL-C \<= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).

  2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]

    Timeframe: 365 Days

    LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

  3. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

  4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180

    Timeframe: 180 Days

    LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

  5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365

    Timeframe: 365 Days

    LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.

  6. Percent Change in Non-HDL-C From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group.

  7. Percent Change in Non-HDL-C From Baseline to Day 180

    Timeframe: 180 Days

    LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.

  8. Percent Change in Non-HDL-C From Baseline to Day 365

    Timeframe: 365 Days

    LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.

  9. Percent Change in HDL-C From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

  10. Percent Change in HDL-C From Baseline to Day 180

    Timeframe: 180 Days

    LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

  11. Percent Change in HDL-C From Baseline to Day 365

    Timeframe: 365 Days

    LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.

  12. Percent Change in Lp(a) From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group.

  13. Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in Apolipoprotein A1 (ApoA1) in obicetrapib group compared to the placebo group.

  14. Percent Change in Total Cholesterol From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group.

  15. Percent Change in Total Cholesterol From Baseline to Day 180

    Timeframe: 180 Days

    LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group.

  16. Percent Change in Total Cholesterol From Baseline to Day 365

    Timeframe: 365 Days

    LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group.

  17. Percent Change in Triglycerides From Baseline to Day 84

    Timeframe: 84 Days

    LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group.

  18. Percent Change in Triglycerides From Baseline to Day 180

    Timeframe: 180 Days

    LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group.

  19. Percent Change in Triglycerides From Baseline to Day 365

    Timeframe: 365 days

    LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research GroupAnniston, United States
  • Central Alabama ResearchBirmingham, United States
  • Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PCBirmingham, United States
  • The Center for Clinical Trials, IncSaraland, United States
  • Syed Research Consultants, LLCSheffield, United States
  • Clinical Research Institute of Arizona, LLCSun City West, United States
  • Synexus Clinical Research US, Inc. / Orange Grove Family PracticeTucson, United States
  • Eclipse Clinical ResearchTucson, United States
  • American Institute of ResearchBeverly Hills, United States
  • Orange County Research CenterTustin, United States
  • Synexus Clinical Research US, Inc.Vista, United States
  • Excel Medical Clinical TrialsBoca Raton, United States
  • Pioneer Clinical StudiesFt. Pierce, United States
  • New Generation of Medical ResearchHialeah, United States
  • East Coast Institute for Research, LLCJacksonville, United States
  • East Coast Institute for Research, LLC - Jacksonville University BlvdJacksonville, United States
  • East Coast Institute for Research- Lake CityLake City, United States
  • ClinCloud LLCMaitland, United States
  • Columbus Clinical Services, LLCMiami, United States
  • Kendall South Medical Center, Inc.Miami, United States
  • Advanced Research Institute IncNew Port Richey, United States
  • Progressive Medical ResearchPort Orange, United States
  • East Coast Institute for ResearchSaint Augustine, United States
  • Synexus Clinical Research US, Inc.The Villages, United States
  • Synexus Clinical Research US, Inc.Atlanta, United States

And 156 more, listed on the interactive page.

Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)