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New shot aims to tame high cholesterol and triglycerides

NCT ID NCT06497127

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an investigational drug called BW-00112 in 145 adults with mixed dyslipidemia, a condition where levels of certain blood fats are too high. Participants receive injections of the drug or a placebo over several months while continuing their usual statin medication. The main goal is to see if BW-00112 safely reduces triglycerides and other fats in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

145 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Alliance for Multispecialty Research, LLC

    Daphne, Alabama, 36526, United States

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research, LLC

    Oak Brook, Illinois, 60523, United States

  • Alliance for Multispecialty Research, LLC

    Park Ridge, Illinois, 60068, United States

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114, United States

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069, United States

  • Clinical Site Partners Leesburg, LLC dba Flourish Research

    Leesburg, Florida, 34748, United States

  • Clinical Site Partners, LLC DBA Flourish Research

    Miami, Florida, 33186, United States

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229, United States

  • East Coast Institute for Research LLC

    Canton, Georgia, 30114, United States

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32204, United States

  • Excel Medical Clinical Trials, LLC, dba Flourish Research

    Boca Raton, Florida, 33434, United States

  • Icahn School of Medicine at Mount Sinai

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

  • Suncoast Research Group, LLC DBA Flourish Research

    Miami, Florida, 33135, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.