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Clinical Trials in the USA / NCT06497127
Active, not recruiting Phase 2

A Study in Patients With Mixed Dyslipidemia

NCT06497127 · tracked via the Priya Life Science USA tracker
Sponsor
Shanghai Argo Biopharmaceutical Co., Ltd.
Phase
Phase 2
Started
2024-02-28
Last updated
2026-01-13

Condition(s) studied

Mixed Dyslipidemia

Investigational drug(s) / intervention(s)

BW-00112

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

Study summary

A Phase 2 in Patients With Mixed Dyslipidemia

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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: 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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Alliance for Multispecialty Research, LLC Daphne Alabama
Alliance for Multispecialty Research, LLC Mobile Alabama
Excel Medical Clinical Trials, LLC, dba Flourish Research Boca Raton Florida
East Coast Institute for Research, LLC Jacksonville Florida
Clinical Site Partners Leesburg, LLC dba Flourish Research Leesburg Florida
Suncoast Research Group, LLC DBA Flourish Research Miami Florida
Clinical Site Partners, LLC DBA Flourish Research Miami Florida
East Coast Institute for Research LLC Canton Georgia
Alliance for Multispecialty Research, LLC Oak Brook Illinois
Alliance for Multispecialty Research, LLC Park Ridge Illinois
Alliance for Multispecialty Research, LLC Newton Kansas
Icahn School of Medicine at Mount Sinai New York New York
Alliance for Multispecialty Research, LLC Norman Oklahoma
Clinical Trials of Texas, LLC San Antonio Texas

More Shanghai Argo Biopharmaceutical Co., Ltd. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06497127 on ClinicalTrials.gov ↗ ← All trials in the USA