A Study in Patients with Mixed Dyslipidemia

Description

A Phase 2 in Patients With Mixed Dyslipidemia

Conditions

Mixed Dyslipidemia

Study Overview

Study Details

Study overview

A Phase 2 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 Study in Patients with Mixed Dyslipidemia

Condition
Mixed Dyslipidemia
Intervention / Treatment

-

Contacts and Locations

Daphne

Alliance for Multispecialty Research, LLC, Daphne, Alabama, United States, 36526

Mobile

Alliance for Multispecialty Research, LLC, Mobile, Alabama, United States, 36608

Boca Raton

Excel Medical Clinical Trials, LLC, dba Flourish Research, Boca Raton, Florida, United States, 33434

Jacksonville

East Coast Institute for Research, LLC, Jacksonville, Florida, United States, 32204

Leesburg

Clinical Site Partners Leesburg, LLC dba Flourish Research, Leesburg, Florida, United States, 34748

Miami

Suncoast Research Group, LLC DBA Flourish Research, Miami, Florida, United States, 33135

Miami

Clinical Site Partners, LLC DBA Flourish Research, Miami, Florida, United States, 33186

Canton

East Coast Institute for Research LLC, Canton, Georgia, United States, 30114

Oak Brook

Alliance for Multispecialty Research, LLC, Oak Brook, Illinois, United States, 60523

Park Ridge

Alliance for Multispecialty Research, LLC, Park Ridge, Illinois, United States, 60068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shanghai Argo Biopharmaceutical Co., Ltd.,

Yuqiong N/A Li, Master, STUDY_DIRECTOR, Shanghai Argo Biopharmaceutical Co., Ltd.

Study Record Dates

2025-09-30