NCT06497127

Brief Summary

A Phase 2 in Patients With Mixed Dyslipidemia

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
23mo left

Started Feb 2024

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Feb 2024Mar 2028

Study Start

First participant enrolled

February 28, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

July 4, 2024

Last Update Submit

January 11, 2026

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Percent change in fasting TG

    Percent change in fasting TG from baseline to Day 180

    From baseline to Day 180

Secondary Outcomes (1)

  • Percent change in fasting TG

    From baseline to Day 15, 30, 60, 90, 135, 225, and 270

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: BW-00112

Cohort 2

EXPERIMENTAL

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

Drug: BW-00112

Cohort 3

EXPERIMENTAL

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

Drug: BW-00112

Interventions

BW-00112DRUG

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have given written informed consent and be able to comply with all study requirements.
  • Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
  • Fasting LDL-C ≥ 70 mg/dL \[1.8 mmol/L\] at Screening.
  • 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.
  • 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.
  • 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

You may not qualify if:

  • Active pancreatitis within 12 weeks prior to Day 1.
  • Clinically significant acute cardiovascular even or procedure
  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Alliance for Multispecialty Research, LLC

Daphne, Alabama, 36526, United States

Location

Alliance for Multispecialty Research, LLC

Mobile, Alabama, 36608, United States

Location

Excel Medical Clinical Trials, LLC, dba Flourish Research

Boca Raton, Florida, 33434, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

Location

Clinical Site Partners Leesburg, LLC dba Flourish Research

Leesburg, Florida, 34748, United States

Location

Suncoast Research Group, LLC DBA Flourish Research

Miami, Florida, 33135, United States

Location

Clinical Site Partners, LLC DBA Flourish Research

Miami, Florida, 33186, United States

Location

East Coast Institute for Research LLC

Canton, Georgia, 30114, United States

Location

Alliance for Multispecialty Research, LLC

Oak Brook, Illinois, 60523, United States

Location

Alliance for Multispecialty Research, LLC

Park Ridge, Illinois, 60068, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Study Officials

  • Yuqiong Li, Master

    Shanghai Argo Biopharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 11, 2024

Study Start

February 28, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

March 30, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(14)