A Study in Patients with Mixed Dyslipidemia

Shanghai Argo Biopharmaceutical Co., Ltd.

Status and phase: Enrolling; Phase 2

Conditions: Mixed Dyslipidemia

Treatments: Drug: BW-00112

Study type: Interventional

Funder types: Industry

Identifiers

NCT06497127

BW-00112-2002

Details and patient eligibility

About

A Phase 2 in Patients With Mixed Dyslipidemia

Full 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

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 3 patient groups

Cohort 1

Experimental group

Description:

BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90

Treatment:

Drug: BW-00112

Cohort 2

Experimental group

Description:

BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90

Treatment:

Drug: BW-00112

Cohort 3

Experimental group

Description:

BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90

Treatment:

Drug: BW-00112