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Obicetrapib for High Cholesterol (BROADWAY Trial)
Phase 3
Waitlist Available
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are on maximally tolerated lipid-modifying therapy including statins, ezetimibe, bempedoic acid, or PCSK-9 targeted therapy
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up percent change from baseline to day 84, day 180, and day 365 in tc
Awards & highlights
BROADWAY Trial Summary
This trial will study whether obicetrapib is effective and safe in people with familial hypercholesterolemia or ASCVD.
Who is the study for?
This trial is for adults with high cholesterol or heart disease who are already on the highest dose of cholesterol-lowering meds they can handle. They should have a specific genetic condition (HeFH) or a history of cardiovascular disease, and their kidneys must work well. Pregnant or breastfeeding women, or those planning to become pregnant during the study, cannot participate.Check my eligibility
What is being tested?
The trial is testing Obicetrapib's effectiveness when added to existing treatments for lowering cholesterol compared to a placebo. It's in phase 3, meaning it's closer to potentially being approved if results are positive. Participants won't know whether they're getting the real drug or a dummy pill.See study design
What are the potential side effects?
While not specified here, common side effects from drugs like Obicetrapib may include digestive issues, muscle pain or weakness, liver problems which might show up as fatigue or yellowing skin/eyes, and increased blood sugar levels.
BROADWAY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking the highest dose of cholesterol medication that I can tolerate.
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I've been on the highest dose of cholesterol medication I can handle for at least 8 weeks.
Select...
I have a genetic condition that causes high cholesterol or a history of heart disease.
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My LDL cholesterol levels fall within the required range.
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I am currently taking Atorvastatin or Rosuvastatin at the specified doses.
BROADWAY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ percent change from baseline to day 84, day 180, and day 365 in tg
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~percent change from baseline to day 84, day 180, and day 365 in tg
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Apolipoprotein A1 (ApoA1)
HDL-C
LDL-C
+5 moreOther outcome measures
Cardiovascular hospitalizations
Major adverse cardiac event (MACE)
BROADWAY Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: obicetrapib 10mgExperimental Treatment1 Intervention
one 10mg obicetrapib tablet once daily
Group II: PlaceboPlacebo Group1 Intervention
one placebo tablet once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
2022
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
10,640 Total Patients Enrolled
6 Trials studying High Cholesterol
1,159 Patients Enrolled for High Cholesterol
Marc DitmarschStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
527 Total Patients Enrolled
3 Trials studying High Cholesterol
527 Patients Enrolled for High Cholesterol
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your fasting triglyceride levels are within a certain range.My cholesterol or other risk factors meet the study's criteria.I have been on a stable dose of the highest statin dose I can tolerate for at least 4 weeks.Your thyroid-stimulating hormone levels are higher than 1.5 times the normal limit.Your blood sugar levels are very high, with HbA1c at 10% or fasting glucose at 270 mg/dL or more.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have an ongoing liver condition.I am taking the highest dose of cholesterol medication that I can tolerate.You have a history of heavy drinking or drug use within the past 5 years.I have not had a major heart problem in the last 3 months.My blood pressure is very high and not under control.Your creatine kinase level is more than three times the normal limit.Your kidneys are working well, with an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m2.My heart's pumping ability is severely reduced.I have a genetic condition that causes high cholesterol or a history of heart disease.Your levels of lipoprotein (a) and HDL-C are within certain ranges after fasting.I've been on the highest dose of cholesterol medication I can handle for at least 8 weeks.I had cancer treatment within the last 3 years.You cannot be breastfeeding.I have been diagnosed with homozygous familial hypercholesterolemia.I am currently taking or have taken gemfibrozil in the last 30 days.My LDL cholesterol levels fall within the required range.I was hospitalized for heart failure within the last 5 years.You have taken part in a study testing obicetrapib.You are allergic to obicetrapib or any of the ingredients in it.I am currently taking Atorvastatin or Rosuvastatin at the specified doses.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: obicetrapib 10mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Cholesterol Patient Testimony for trial: Trial Name: NCT05142722 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this kind of treatment been tested before?
"NewAmsterdam Pharma sponsored the first Obicetrapib study in 2021, which completed Phase 3 approval in 2400 participants across 32 cities and 2 countries. To date, 18272 trials have been completed."
Answered by AI
Is this research being conducted across several hospitals in North America?
"Currently, patients are being accepted at 35 clinical trial locations, which include Arcturus Healthcare, Troy Internal Medicine Research Division in Troy, Michigan, Monument Health Clinical Research in Rapid City, South dakota, and Research Integrity, LLC in Owensboro, Kentucky."
Answered by AI
What is the maximum patient volume for this trial?
"That is correct. The clinicaltrials.gov website indicates that this study, which was originally posted on December 15th, 2021, is still recruiting individuals. There are 35 sites involved in the study and they are looking to enroll 2400 people in total."
Answered by AI
To the best of your knowledge, are there other research projects that have used Obicetrapib?
"The first Obicetrapib study was completed in 2021 at Pinnacle Research Group. Out of the 18272 total studies, 2 are still ongoing. A majority of these experiments are being conducted in Troy, Michigan."
Answered by AI
Is Obicetrapib available for legal purchase in the United States?
"Obicetrapib has received a Phase 3 rating, which means that there is efficacy data as well as multiple rounds of safety data. Our teamPower has estimated the safety to be a 3 on a scale from 1 to 3."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Tennessee
Other
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
The Center for Clinical Trials, Inc
Orange County Research Center
Biofortis, Inc
Other
How many prior treatments have patients received?
0
1
3+
Why did patients apply to this trial?
Since I’ve been diagnosed with diabetes I also now have high cholesterol. I try to eat right, but I’m desperate to find out how to get off some of my medications. I have dieted and exercised, but due to severe neuropathy I no longer can exercise. Please help!!
PatientReceived no prior treatments
I have been on cholesterol medication for countless years and rarely can get my counts down to normal. Plus there is a paternal history of heart issues, high cholesterol and blood pressure. Recently a test showed that I have the beginnings of build up in one vein to my heart.
PatientReceived no prior treatments
I have elevated Lipoprotein (a) with slightly elevated LDL. Total chol approx 180. A heart CT several months ago showed Calcium buildup in my LAD. Was since prescribed two different statins.. Had Angiogram (and Stent placement) last week in LAD showing 99 percent blockage in LAD. Interested in something that might lower my Lipoprotein (a) instead of raising it which the stains apparently do.
PatientReceived 1 prior treatment
For one, as a husband and parent I would like the extra money before the holiday's. This study specifically stuck out to me because my grandpa died at the age of 55 due to his 2 heart attack. I know he had high cholesterol & heart problems. My Uncles have also died due to their cholesterol or heart problems. I know high cholesterol runs in my family. Still it's something I haven't thought much about or try not too. But this were to help me or anyone else with cholesterol I would be more than willing to do it.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
I've never done anything like this before, how long would this process be? Would it affect my work? Also what would the payment look like?
PatientReceived 1 prior treatment
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