Loading clinical trials...

A Study in Patients With Mixed Dyslipidemia | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study 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

NCT06497127•Shanghai Argo Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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
•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.

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.

Locations (14)

Alliance for Multispecialty Research, LLC

Daphne, Alabama, United States

Alliance for Multispecialty Research, LLC

Mobile, Alabama, 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

Alliance for Multispecialty Research, LLC

Oak Brook, Illinois, United States

Alliance for Multispecialty Research, LLC

Park Ridge, Illinois, United States

Key Dates

Start Date

February 28, 2024

Primary Completion Date

June 30, 2026

Completion Date

March 30, 2028

Last Updated

January 13, 2026

Enrollment

145

ACTUAL participants

Conditions

Mixed Dyslipidemia

Interventions

BW-00112

DRUG

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

NCT06314919

Primary HypercholesterolemiaMixed Dyslipidemia

View study

RECRUITINGPHASE1

A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

NCT06932705

Mixed Dyslipidemia

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study in Patients With Mixed Dyslipidemia

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of SAL003 in Combination With Statin Therapy in Patients With Hypercholesterolemia and Mixed Dyslipidemia

Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)