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Active, not recruitingNCT06497127Updated Jan 13, 2026

A Study in Patients With Mixed Dyslipidemia

A Phase 2 interventional study of BW-00112 in Mixed Dyslipidemia, sponsored by Shanghai Argo Biopharmaceutical Co., Ltd.. Active, not recruiting at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Shanghai Argo Biopharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
  • Registered 4 months after the study started (first participant enrolled Feb 2024, registered Jul 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

A Phase 2 in Patients With Mixed Dyslipidemia

Read the 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

02

Conditions studied

  • Mixed Dyslipidemia
03

In context

Lead sponsor

Shanghai Argo Biopharmaceutical Co., Ltd. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    Cohort 1

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

    Drug: BW-00112

  • Experimental
    Cohort 2

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

    Drug: BW-00112

  • Experimental
    Cohort 3

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

    Drug: BW-00112

Interventions

  • DrugBW-00112

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

06

What researchers measure

Primary outcomes

  1. Percent change in fasting TG

    Percent change in fasting TG from baseline to Day 180

    Time frame: From baseline to Day 180

Secondary outcomes

  1. Percent change in fasting TG

    Percent change in fasting TG from baseline to Day 15, 30, 60, 90, 135, 225, and 270

    Time frame: From baseline to Day 15, 30, 60, 90, 135, 225, and 270

07

Study locations

14 sites
  • Alliance for Multispecialty Research, LLC
    Daphne, Alabama 36526, United States
  • Alliance for Multispecialty Research, LLC
    Mobile, Alabama 36608, United States
  • Excel Medical Clinical Trials, LLC, dba Flourish Research
    Boca Raton, Florida 33434, United States
  • East Coast Institute for Research, LLC
    Jacksonville, Florida 32204, United States
  • Clinical Site Partners Leesburg, LLC dba Flourish Research
    Leesburg, Florida 34748, United States
  • Suncoast Research Group, LLC DBA Flourish Research
    Miami, Florida 33135, United States
  • Clinical Site Partners, LLC DBA Flourish Research
    Miami, Florida 33186, United States
  • East Coast Institute for Research LLC
    Canton, Georgia 30114, United States
  • Alliance for Multispecialty Research, LLC
    Oak Brook, Illinois 60523, United States
  • Alliance for Multispecialty Research, LLC
    Park Ridge, Illinois 60068, United States
  • Alliance for Multispecialty Research, LLC
    Newton, Kansas 67114, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029-6574, United States
  • Alliance for Multispecialty Research, LLC
    Norman, Oklahoma 73069, United States
  • Clinical Trials of Texas, LLC
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06497127
Lead sponsor
Shanghai Argo Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 11, 2024
Start date
Feb 28, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Jan 13, 2026

Study contacts

Yuqiong Li, Master
study director · Shanghai Argo Biopharmaceutical Co., Ltd.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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