A Study in Patients With Mixed Dyslipidemia

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

A Phase 2 in Patients With Mixed Dyslipidemia

Study Overview

• Status: Active, not recruiting
• Conditions: Mixed Dyslipidemia
• Intervention / Treatment: Drug: BW-00112

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Alliance for Multispecialty Research, LLC
    • Mobile, Alabama, United States, 36608
      • Alliance for Multispecialty Research, LLC
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials, LLC, dba Flourish Research
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research, LLC
    • Leesburg, Florida, United States, 34748
      • Clinical Site Partners Leesburg, LLC dba Flourish Research
    • Miami, Florida, United States, 33186
      • Clinical Site Partners, LLC dba Flourish Research
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC dba Flourish Research
  • Georgia
    • Canton, Georgia, United States, 30114
      • East Coast Institute For Research LLC
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • Alliance for Multispecialty Research, LLC
    • Park Ridge, Illinois, United States, 60068
      • Alliance for Multispecialty Research, LLC
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
  • New York
    • New York, New York, United States, 10029-6574
      • ICAHN School of Medicine at Mount Sinai
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Alliance for Multispecialty Research, LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must have given written informed consent and be able to comply with all study requirements.
2. Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
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 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 diabetic ketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks prior to Day 1.
4. Presence of any clinically significant uncontrolled disease known to influence serum lipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligible if 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 other cholesterol lowering medication 30 days prior to Day 1, other than statins and ezetimibe.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90	Drug: BW-00112; BW-00112 or volume-matched placebo on Day 1 and Day 90; Other Names: No other name
Experimental: Cohort 2; BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90	Drug: BW-00112; BW-00112 or volume-matched placebo on Day 1 and Day 90; Other Names: No other name
Experimental: Cohort 3; BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90	Drug: BW-00112; BW-00112 or volume-matched placebo on Day 1 and Day 90; Other Names: No other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in fasting TG	Percent change in fasting TG from baseline to Day 180	From baseline to Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in fasting TG	Percent change in fasting TG from baseline to Day 15, 30, 60, 90, 135, 225, and 270	From baseline to Day 15, 30, 60, 90, 135, 225, and 270

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in fasting LDL-C, non-HDL-C, VLDL-C, ApoB and remnant-C	Percent change in fasting LDL-C, non-HDL-C, VLDL-C, ApoB and remnant-C from baseline at each subsequent visit to Day 270	From baseline and at each subsequent visit to Day 270

Collaborators and Investigators

• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
• Investigators: Study Director: Yuqiong Li, Master, Shanghai Argo Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: BW-00112-2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No