Clinical trial NCT06497127: A Study 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mixed Dyslipidemia
Lead sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Percent change in fasting TG
timeFrame: From baseline to Day 180
Secondary outcomes:
measure: Percent change in fasting TG
timeFrame: From baseline to Day 15, 30, 60, 90, 135, 225, and 270
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC, dba Flourish Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners Leesburg, LLC dba Flourish Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC DBA Flourish Research
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC DBA Flourish Research
state: Florida
city: Canton
country: United States
facility: East Coast Institute for Research LLC
state: Georgia
city: Oak Brook
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Illinois
city: Park Ridge
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Illinois
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
Study officials:
affiliation: Shanghai Argo Biopharmaceutical Co., Ltd.
name: Yuqiong N/A Li, Master
role: STUDY_DIRECTOR
References: