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NCT06497127 | RECRUITING | Mixed Dyslipidemia

A Study in Patients with Mixed Dyslipidemia
Sponsor:

Shanghai Argo Biopharmaceutical Co., Ltd.

Brief Summary:

A Phase 2 in Patients With Mixed Dyslipidemia

Condition or disease

Mixed Dyslipidemia

Intervention/treatment

BW-00112

Phase

PHASE2

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
Estimated Enrollment : 132 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-06-21
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study in Patients with Mixed Dyslipidemia

Location Details

NCT06497127

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

Alliance for Multispecialty Research, LLC

Dafne, Albama, United States, 36526

RECRUITING

United States, Albama

Alliance for Multispecialty Research, LLC

Mobile, Albama, United States, 36608

RECRUITING

United States, Florida

Excel Medical Clinical Trials, LLC, dba Flourish Research

Boca Raton, Florida, United States, 33434

COMPLETED

United States, Florida

East Coast Institute for Research, LLC

Jacksonville, Florida, United States, 32204

RECRUITING

United States, Florida

Clinical Site Partners Leesburg, LLC dba Flourish Research

Leesburg, Florida, United States, 34748

RECRUITING

United States, Florida

Suncoast Research Group, LLC DBA Flourish Research

Miami, Florida, United States, 33135

RECRUITING

United States, Florida

Clinical Site Partners, LLC DBA Flourish Research

Miami, Florida, United States, 33186

RECRUITING

United States, Georgia

East Coast Institute for Research LLC

Canton, Georgia, United States, 30114

RECRUITING

United States, Illinois

Alliance for Multispecialty Research, LLC

Oak Brook, Illinois, United States, 60523

RECRUITING

United States, Illinois

Alliance for Multispecialty Research, LLC

Park Ridge, Illinois, United States, 60068

RECRUITING

United States, Kansas

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States, 67114

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

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

RECRUITING

United States, Oklahola

Alliance for Multispecialty Research, LLC

Norman, Okholohan, United States, 73069

RECRUITING

United States, Texas

Clinical Trials of Texas, LLC

San Antonio, Texas, United States, 78229