A Study in Patients With Mixed Dyslipidemia

Last updated: January 11, 2026
Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

BW-00112

Clinical Study ID

NCT06497127
BW-00112-2002
  • Ages 18-75
  • All Genders

Study Summary

A Phase 2 in Patients With Mixed Dyslipidemia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must have given written informed consent and be able to comply with all studyrequirements.

  2. Males or females aged 18 to 75 aged years, inclusive, at the time of informedconsent

  3. Fasting LDL-C ≥ 70 mg/dL [1.8 mmol/L] at Screening.

4.150 mg/dL [1.7 mmol/L] ≤ fasting TG < 500 mg/dL [5.6 mmol/L] at Screening, which may be repeated once if deemed necessary.

5.On a stable statin for at least 1 month before Screening and plan to remain on the same medication and dose for the duration of the study.

6.Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal 7.Male patients agreeing to use acceptable methods of contraception

Exclusion

Exclusion Criteria:

  1. Active pancreatitis within 12 weeks prior to Day 1.

  2. Clinically significant acute cardiovascular even or procedure

  3. HbA1c > 9.0% at Screening or patients with diabetes who have experienced diabeticketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma,diabetes complications, recurrent infections, or hospitalization related to poorglycemic control within 24 weeks prior to Day 1.

  4. Presence of any clinically significant uncontrolled disease known to influence serumlipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligibleif the dosage of thyroxine has been stable for at least 12 weeks prior to Day 1.

  5. Use of TG lowering medication , non-prescription dietary supplements or othercholesterol lowering medication 30 days prior to Day 1, other than statins andezetimibe.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: BW-00112
Phase: 2
Study Start date:
February 28, 2024
Estimated Completion Date:
March 30, 2028

Study Description

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients with Mixed Dyslipidemia

Connect with a study center

  • Alliance for Multispecialty Research, LLC

    Daphne, Alabama 36526
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Daphne 4058219, Alabama 4829764 36526
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Mobile 4076598, Alabama 4829764 36608
    United States

    Site Not Available

  • Excel Medical Clinical Trials, LLC, dba Flourish Research

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Clinical Site Partners Leesburg, LLC dba Flourish Research

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Clinical Site Partners, LLC DBA Flourish Research

    Miami, Florida 33186
    United States

    Site Not Available

  • Suncoast Research Group, LLC DBA Flourish Research

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials, LLC, dba Flourish Research

    Boca Raton 4148411, Florida 4155751 33434
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville 4160021, Florida 4155751 32204
    United States

    Site Not Available

  • Clinical Site Partners Leesburg, LLC dba Flourish Research

    Leesburg 4161771, Florida 4155751 34748
    United States

    Site Not Available

  • Clinical Site Partners, LLC DBA Flourish Research

    Miami 4164138, Florida 4155751 33186
    United States

    Site Not Available

  • Suncoast Research Group, LLC DBA Flourish Research

    Miami 4164138, Florida 4155751 33135
    United States

    Site Not Available

  • East Coast Institute for Research LLC

    Canton, Georgia 30114
    United States

    Site Not Available

  • East Coast Institute for Research LLC

    Canton 4186213, Georgia 4197000 30114
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Oak Brook 4904277, Illinois 4896861 60523
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Park Ridge 4905367, Illinois 4896861 60068
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Newton 4276248, Kansas 4273857 67114
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029-6574
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029-6574
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman 4543762, Oklahoma 4544379 73069
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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