ABP-745 for Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ABP-745 to determine if it can reduce plaque buildup in the arteries of individuals with cardiovascular disease. Participants will receive one of three different doses of ABP-745 or a placebo while continuing their usual cholesterol-lowering medications. The goal is to assess whether ABP-745 improves artery health over a year. This trial may suit those diagnosed with coronary atherosclerosis who are already taking oral cholesterol-lowering medication. As a Phase 2 trial, this research measures how well ABP-745 works in an initial, smaller group, offering participants a chance to contribute to important cardiovascular research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be using oral lipid-lowering therapy, so you may need to continue those medications.
Is there any evidence suggesting that ABP-745 is likely to be safe for humans?
Research has shown that ABP-745 is being tested for its safety in treating heart disease. Earlier studies indicate that ABP-745 is well-tolerated and does not interfere with other medications, which is crucial for individuals already on heart treatments. Animal tests have compared ABP-745 to colchicine, a common drug, and found it safe. So far, these studies have reported no major side effects, suggesting that ABP-745 could be a safe option for patients. However, as the treatment remains in the early stages of human testing, ongoing studies will provide a clearer picture of its safety.12345
Why do researchers think this study treatment might be promising for cardiovascular disease?
Researchers are excited about ABP-745 for cardiovascular disease because it offers a novel approach compared to existing treatments like statins, which mainly focus on reducing cholesterol levels. ABP-745 is unique as it potentially targets different pathways related to lipid management, which might help in better controlling cardiovascular risk factors. This could mean more comprehensive protection against heart disease, especially for patients who do not respond well to current therapies. Additionally, the study is exploring different dosing options (Dose A, B, and C), which might offer flexibility in tailoring treatments to individual patient needs.
What evidence suggests that ABP-745 might be an effective treatment for ASCVD?
Research has shown that ABP-745 might help reduce plaque buildup in the arteries of people with heart disease. Early findings suggest that ABP-745 reduces inflammation, a key factor in plaque formation. Previous patients tolerated the drug well, experiencing no serious side effects, and it showed promise in addressing inflammation-related problems. These early results indicate that ABP-745 could be a promising treatment for those with heart disease. Participants in this trial will receive different doses of ABP-745 or a placebo to further evaluate its effectiveness and safety.13567
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-75 with diagnosed coronary atherosclerosis, weighing at least 40 kg, currently on oral lipid-lowering therapy. They must understand the study and agree to use contraception during and for 3 months after the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABP-745 or placebo for 52 weeks to evaluate efficacy in reducing atherosclerotic plaque
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABP-745
Trial Overview
The study tests ABP-745's ability to reduce atherosclerotic plaque in patients with ASCVD against a placebo. It's randomized, double-blind, and measures efficacy primarily at one year of treatment.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Existing lipid-lowering maintenance medications unchanged.
Existing lipid-lowering maintenance medications unchanged.
Existing lipid-lowering maintenance medications unchanged.
Existing lipid-lowering maintenance medications unchanged.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atom Therapeutics Co., Ltd
Lead Sponsor
Citations
A Phase II Study to Evaluate the Efficacy, Safety, and ...
This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in ...
2.
businesswire.com
businesswire.com/news/home/20251210860210/en/Atom-Therapeutics-Launches-Multi-Regional-Phase-2-Trial-of-ABP-745-for-Atherosclerotic-Cardiovascular-Disease-ASCVDAtom Therapeutics Launches Multi-Regional Phase 2 Trial ...
Colchicine became the first anti-inflammatory drug approved by the FDA in 2023 for the treatment of cardiovascular disease. On top of standard ...
ABP-745 for Cardiovascular Disease · Info for Participants
The study tests ABP-745's ability to reduce atherosclerotic plaque in patients with ASCVD against a placebo. It's randomized, double-blind, and ...
4.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/atom-therapeutics-global-phase-ii-trial-novel-anti-inflammatory-treatment-acute-gout-flaresAtom Therapeutics Launches Global Phase II Trial of Novel ...
The Phase II trial (NCT07145229) will evaluate the safety, efficacy, and pharmacodynamics of ABP-745 compared with placebo and standard ...
Atom Therapeutics to Present Positive Data from Clinical ...
The Phase 1 study of ABP-745 in healthy volunteers demonstrated the drug was well-tolerated and exhibited dose proportional pharmacokinetics ...
Atom Therapeutics Launches Multi-Regional Phase 2 Trial ...
ABP-745, administered orally, poses no risk of drug-drug interactions. Animal studies have shown that, compared with colchicine, its therapeutic ...
Safety and Efficacy of ABP-745 in Participants With an ...
A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ABP-745 in subjects ...
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