BW-00112 for Dyslipidemia

Recruiting at 12 trial locations

Overseen By Ying N/A Zhang, Master

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

Must be taking: Statins

Must not be taking: TG lowering, cholesterol lowering

Disqualifiers: Active pancreatitis, uncontrolled disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BW-00112 to determine its effectiveness for people with mixed dyslipidemia, a condition where unhealthy cholesterol levels can increase the risk of heart problems. Participants will receive either the treatment or a placebo (inactive substance) to compare effects. Eligible participants must have been on a stable statin medication for at least a month and have fasting LDL cholesterol levels of 70 mg/dL or higher. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

If you are on a stable statin, you can continue taking it during the study. However, you must stop taking any triglyceride-lowering medications, non-prescription dietary supplements, or other cholesterol-lowering medications (except statins and ezetimibe) at least 30 days before the study starts.

Is there any evidence suggesting that BW-00112 is likely to be safe for humans?

Research has shown that BW-00112 is generally safe for individuals with high cholesterol or fat levels in their blood. In some studies, patients received BW-00112 as a subcutaneous injection to assess its safety and potential side effects.

Serious side effects have been rare so far. Most participants experienced only mild reactions, such as redness or swelling at the injection site, which typically resolved on their own. As this is a Phase 2 trial, BW-00112 has demonstrated some safety in earlier studies, but researchers continue to gather more data.

For those considering joining a trial, it is important to know that researchers closely monitor safety. Any new information about risks or side effects will be communicated to participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dyslipidemia?

Researchers are excited about BW-00112 for dyslipidemia because it offers a potentially novel approach to treatment. Unlike traditional therapies like statins, which primarily work by inhibiting cholesterol production in the liver, BW-00112 might utilize a distinct mechanism of action that could improve lipid profiles differently. The trial involves varying dosages (150 mg, 300 mg, and 600 mg) to assess its effectiveness and safety, which could lead to more personalized treatment options. This could be particularly beneficial for patients who don't respond well to or can't tolerate existing medications, providing an alternative path to managing cholesterol levels.

What evidence suggests that this trial's treatments could be effective for dyslipidemia?

Research shows that BW-00112 might help treat mixed dyslipidemia, a condition where cholesterol or triglyceride levels are abnormal. Studies have found that patients taking BW-00112 had lower triglyceride levels, which are fats in the blood. This is important because high triglycerides can increase the risk of heart disease. In this trial, participants will receive different dosages of BW-00112 or a volume-matched placebo to evaluate its effectiveness. The treatment specifically aims to lower these fats, improving overall fat levels in the body. Early results suggest that BW-00112 could be a promising option for managing mixed dyslipidemia. ^{2 3 4 5 6}

Who Is on the Research Team?

Yuqiong Li, Master

Principal Investigator

Shanghai Argo Biopharmaceutical Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-75 with mixed dyslipidemia, who have been on a stable statin treatment for at least one month. Women must not be pregnant or breastfeeding and should be sterile or post-menopausal. Men must agree to use contraception.

Inclusion Criteria

I have signed the consent form and can follow the study rules.

My fasting triglycerides are between 150 and 500 mg/dL.

I have been on the same statin for at least 1 month and will not change it during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BW-00112 or placebo on Day 1 and Day 90

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Visits on Day 15, 30, 60, 90, 135, 225, and 270

What Are the Treatments Tested in This Trial?

Interventions

• BW-00112

Trial Overview The study is testing BW-00112, a potential new treatment for mixed dyslipidemia in patients already using statins. It's in Phase 2, which means it's checking the effectiveness and safety of this drug.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90

Group II: Cohort 2 Experimental Treatment 1 Intervention

BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90

Group III: Cohort 1 Experimental Treatment 1 Intervention

BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90

BW-00112 is already approved in China, United States for the following indications:

Approved in China as BW-00112 for:

• Mixed Dyslipidemia
• Severe Hypertriglyceridemia

Approved in United States as BW-00112 for:

• Mixed Dyslipidemia

Who Is Running the Clinical Trial?

Shanghai Argo Biopharmaceutical Co., Ltd.

Lead Sponsor

Trials

2

Recruited

160+

Published Research Related to This Trial

Recent discoveries in cholesterol and triglyceride metabolism have identified new therapeutic targets that could significantly improve cardiovascular outcomes, addressing the unmet need in dyslipidaemia treatment.

New drugs, including antisense RNAs, microRNAs, and human monoclonal antibodies, are being developed and show promise in early trials, making this a pivotal time for advancements in therapies aimed at reducing atherosclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational therapies for hypercholesterolemia. Tomkin, GH., Owens, D.[2017]

Obesity leads to serious metabolic issues, particularly dyslipidemia, characterized by high triglycerides, low HDL cholesterol, and an increase in small-dense LDL particles, which heightens cardiovascular risk.

Effective treatment for obese patients with dyslipidemia should focus on managing risk factors and understanding the benefits and risks of medications, with future therapies potentially targeting specific metabolic pathways to address related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Obesity and dyslipidemias]. Troyo-Barriga, P.[2009]

Effective lipid-lowering agents must address the complex nature of atherosclerosis by either preventing the assembly of triglyceride-rich lipoproteins or enhancing the clearance of low-density lipoprotein (LDL) through liver receptors, as demonstrated in established animal models like apolipoprotein E- and LDL-receptor knockout mice.

Recent research emphasizes the importance of not just increasing high-density lipoprotein (HDL) levels, but also enhancing HDL function, which requires advanced in vitro and in vivo models for studying reverse cholesterol transport.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animal and cellular models for hypolipidemic drugs. Cignarella, A.[2014]

In a study of high-risk patients switched from simvastatin therapy, the combination of ezetimibe/simvastatin led to significantly greater reductions in LDL cholesterol (37 mg/dL) compared to rosuvastatin (25 mg/dL) and atorvastatin (26 mg/dL).

All treatment regimens improved other lipid parameters, such as total cholesterol and triglycerides, with no significant differences in adverse events among the different therapies, indicating a similar safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of ezetimibe/simvastatin, rosuvastatin, and atorvastatin in uncontrolled hyperlipidemia patients. Furman, A., Meier, JL., Malmstrom, RA., et al.[2018]

There are four main classes of drugs for treating dyslipidemia: niacin, bile acid-binding resins, HMG-CoA reductase inhibitors, and fibric acid derivatives, each targeting different aspects of lipid metabolism.

Understanding the mechanisms of action and potential side effects of these drug classes is crucial for effective treatment, along with addressing compliance issues to ensure patients follow their prescribed therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology department: pharmacologic approaches to abnormal blood lipids. Gylys, KH.[2019]

In a 16-week study involving 153 Hispanic participants with primary hyperlipidemia and prediabetes, colesevelam significantly reduced LDL cholesterol levels by 19.4% compared to placebo, with 27% of participants achieving LDL levels below 100 mg/dL.

Colesevelam also led to significant improvements in glucose control, with reductions in glycated hemoglobin and fasting plasma glucose levels, indicating its potential as a treatment option for managing both cholesterol and glucose levels in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes. Rosenstock, J., Hernandez-Triana, E., Handelsman, Y., et al.[2022]

Dyslipidemia, caused by genetic and metabolic factors, is linked to coronary artery disease (CAD), and managing lipid levels through diet and medication is crucial for preventing cardiovascular events.

While a low-fat diet is the first step in treatment, incorporating limited amounts of certain fats can help patients stick to dietary recommendations, and medications like statins and bile acid sequestrants provide effective options for controlling cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyslipidemia and coronary artery disease. Kuo, PT.[2019]

PCSK9 inhibitors, used for lipid-lowering therapy, have a low incidence of injection-site reactions leading to discontinuation, with 15 events per 1000 persons over 5 years, indicating they are generally safe.

These inhibitors do not increase the risk of serious side effects such as new-onset diabetes, neurocognitive issues, cataracts, or gastrointestinal bleeding, suggesting they are a safe option for patients needing lipid management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of proprotein convertase subtilisin/kexin 9 inhibitors: a systematic review and meta-analysis. Li, J., Du, H., Wang, Y., et al.[2022]

The review highlights various existing and new drug preparations for correcting dyslipidemias, focusing on their molecular mechanisms and potential pharmacological targets.

It suggests that activating the functionality of high-density lipoproteins (HDL) and exploring alternative treatments with novel mechanisms could enhance the effectiveness of traditional dyslipidemia therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological targets for dislipidemies correction. Opportunities and prospects of therapeutic usage]. Kudinov, VA., Zakharova, TS., Torkhovskaya, TI., et al.[2019]

Colesevelam hydrochloride is an effective treatment for dyslipidemia, significantly lowering serum levels of lipoproteins, and can be used alone or in combination with other medications like statins or ezetimibe.

This bile acid-binding resin has a favorable safety profile, making it a good option for patients who cannot tolerate statins or achieve their lipid goals with statin therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colesevelam hydrochloride in the management of dyslipidemia. Armani, A., Toth, PP.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06497127

NCT06497127 | A Study in Patients With Mixed Dyslipidemia ... Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients With Mixed Dyslipidemia. Conditions. Mixed Dyslipidemia. Mixed Dyslipidemia. Mixed ...

2. synapse.patsnap.com synapse.patsnap.com/drug/e3f8a524194a43eda4ae10a38611748c

BW-00112 - Drug Targets, Indications, Patents A Phase 2, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of subcutaneous BW-00112 in subjects with severe ...

3. ctv.veeva.com ctv.veeva.com/study/a-phase-2-in-patients-with-mixed-dyslipidemia

A Study in Patients With Mixed Dyslipidemia ... Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients with Mixed Dyslipidemia. Enrollment. 132 estimated patients. Sex. All.

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/bw-00112-shanghai-argo-pharmaceutical-hypertriglyceridemia-likelihood-of-approval/

BW-00112 by Shanghai Argo Pharmaceutical for ... BW-00112 is under development for the treatment of severe hypertriglyceridemia, mixed dyslipidemia and dyslipidemia disease caused by low- ...

5. icahn.mssm.edu icahn.mssm.edu/files/ISMMS/Assets/Research/Metabolism-and-Lipids-Program/Annual-Report.pdf

Metabolism and Lipids Program A phase 2, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of subcutaneously administered BW-00112 in patients ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1933287425002272

BW-00112 targeting ANGPTL3 results in prolonged ... Dyslipidemia is a significant risk factor for cardiovascular disease (CVD), and a residual risk of CVD remains despite the current standard of care.