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Evaluating a new treatment for 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

Phase 2 Interventional Shanghai Argo Biopharmaceutical Co., Ltd. · NCT06497127

This study is testing a new medication for people with mixed dyslipidemia to see if it can help manage their cholesterol levels while they continue taking their regular statin medication.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorShanghai Argo Biopharmaceutical Co., Ltd. Industry-sponsored
Locations14 sites (Daphne, Alabama and 13 other locations)
Trial IDNCT06497127 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial is designed to assess the efficacy and safety of a new medication, BW-00112, administered subcutaneously to patients with mixed dyslipidemia. The study employs a randomized, double-blind, placebo-controlled, parallel design to ensure robust results. Participants will be monitored for their response to the treatment while remaining on a stable statin regimen. The trial aims to gather data on how well the new treatment can manage lipid levels in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are males and females aged 18 to 75 with specific lipid profile criteria and stable statin use.

Not a fit: Patients with active pancreatitis, recent significant cardiovascular events, or poorly controlled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lipid management for patients with mixed dyslipidemia.

How similar studies have performed: Previous studies on lipid management have shown promise with similar therapeutic approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Daphne, Alabama and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mixed Dyslipidemia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.