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New butyrate pill tested alongside statins for cholesterol control

NCT ID NCT06556745

Disease control Sponsor: BioKier Inc. Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new drug called BKR-017 in 9 adults already taking statins for high cholesterol. Researchers checked how the body handles BKR-017 and whether it builds up over a week of twice-daily dosing. The main goal was to see if it is safe and how it affects butyrate levels 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.

Participants

9 people

The number who actually took part.

Started

Jul 2025

Finished

Jun 2026

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.

Who is studied

Healthy subjects on statin therapy between the ages of 18 and 70, inclusive.

Ages

18 to 70 years

Sex

Anyone

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: * Men and women, ages 18-70 inclusive * Subjects currently on statin treatments. Exclusion Criteria: * Presence of cirrhosis, or other causes of liver disease * Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men) * History of bariatric or intestinal surgery * Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis. * Active and clinically significant pancreatic disease, or renal disease as determined by the investigator. * History of heart disease that in the opinion of the investigator should exclude the subject from the study. * Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease * Active significant infection as determined by the investigator. * Known allergy to butyrate or any of the components of the tablets. * Participation in a clinical trial and/or Dosing with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer) * Pregnant, nursing, or trying to become pregnant. * In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study. * Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Hypercholesterolemia

Contacts and locations

Locations

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808, United States

More trials for these conditions

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