A Study in Patients with Mixed Dyslipidemia

Phase 2

Recruiting

• Conditions: Mixed Dyslipidemia
• Interventions: Drug: BW-00112

• Registration Number: NCT06497127
• Lead Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

Brief Summary

A Phase 2 in Patients With Mixed Dyslipidemia

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 Timeline

• Study Start: 2024-06-21
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-11
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	BW-00112	BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90
Cohort 1	BW-00112	BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90
Cohort 2	BW-00112	BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90

Primary Outcome Measures

Name	Time	Method
Percent change in fasting TG	From baseline to Day 180	Percent change in fasting TG from baseline to Day 180

Secondary Outcome Measures

Name	Time	Method
Percent change in fasting TG	From baseline to Day 15, 30, 60, 90, 135, 225, and 270	Percent change in fasting TG from baseline to Day 15, 30, 60, 90, 135, 225, and 270

Trial Locations

Locations (9)

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

Excel Medical Clinical Trials, LLC, dba Flourish Research; 🇺🇸 Boca Raton, Florida, United States

East Coast Institute for Research, LLC; 🇺🇸 Jacksonville, Florida, United States

Clinical Site Partners Leesburg, LLC dba Flourish Research; 🇺🇸 Leesburg, Florida, United States

Suncoast Research Group, LLC DBA Flourish Research; 🇺🇸 Miami, Florida, United States

Clinical Site Partners, LLC DBA Flourish Research; 🇺🇸 Miami, Florida, United States

East Coast Institute for Research LLC; 🇺🇸 Canton, Georgia, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Clinical Trials of Texas, LLC; 🇺🇸 San Antonio, Texas, United States