ACTIVE_NOT_RECRUITING

A Study in Patients With Mixed Dyslipidemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 2 in Patients With Mixed Dyslipidemia

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

Quick Facts

Study Start:2024-02-28

Study Completion:2028-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06497127

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Yuqiong Li, Master

STUDY_DIRECTOR

Shanghai Argo Biopharmaceutical Co., Ltd.

Study Locations (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

Collaborators and Investigators

Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

Yuqiong Li, Master, STUDY_DIRECTOR, Shanghai Argo Biopharmaceutical Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-28

Study Completion Date2028-03-30

Study Record Updates

Study Start Date2024-02-28

Study Completion Date2028-03-30

Terms related to this study

Additional Relevant MeSH Terms

Mixed Dyslipidemia