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BW-00112 for Dyslipidemia

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

A Phase 2 in Patients With Mixed Dyslipidemia

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 BW-00112 (colesevelam) safe for humans?

Colesevelam, also known as BW-00112, has a favorable safety profile and is generally well-tolerated in humans. It is a bile acid-binding resin used to manage dyslipidemia and has been shown to have minimal side effects when used alone or with other medications.¹ ² ³ ⁴ ⁵

How does the drug BW-00112 differ from other dyslipidemia treatments?

BW-00112 may offer a novel approach to treating dyslipidemia by potentially targeting new pharmacological pathways, which could improve the effectiveness of traditional treatments. This could involve unique mechanisms of action not found in existing drugs like statins or bile acid sequestrants.⁶ ⁷ ⁸ ⁹ ¹⁰

Research Team

Yuqiong N/A Li, Master

Principal Investigator

Shanghai Argo Biopharmaceutical Co., Ltd.

Eligibility Criteria

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.

See 3 more

Trial Timeline

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

Treatment Details

Interventions

BW-00112 (Other)

Trial OverviewThe 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.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

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

Group II: Cohort 2Experimental Treatment1 Intervention

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

Group III: Cohort 1Experimental Treatment1 Intervention

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

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

Approved in China as BW-00112 for:

Mixed Dyslipidemia
Severe Hypertriglyceridemia

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Alliance for Multispecialty Research, LLCDaphne, AL

Alliance for Multispecialty Research, LLCMobile, AL

Excel Medical Clinical Trials, LLC, dba Flourish ResearchBoca Raton, FL

Clinical Site Partners Leesburg, LLC dba Flourish ResearchLeesburg, FL

More Trial Locations

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Who Is Running the Clinical Trial?

Shanghai Argo Biopharmaceutical Co., Ltd.

Lead Sponsor

Trials

Patients Recruited

160+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]