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LODOCO STINT Pilot Study for Statin Intolerance

This study is testing a low dose of colchicine (LODOCO) in people who have had side effects from statin medications. Statins help lower cholesterol and prevent heart problems, but some people can't take them due to side effects. LODOCO is an anti-inflammatory drug that may help reduce the risk of heart problems. Researchers want to see if LODOCO is safe and effective in people who can't take statins. They will measure safety by tracking any side effects and effectiveness by looking at changes in a marker of inflammation called high-sensitivity C-reactive protein (hs-CRP). You may be able to join if you are between 18 and 80 years old and have experienced statin intolerance. This study is currently recruiting 30 participants.

Study design
This is an interventional study with 30 planned participants. It will compare low-dose colchicine (LODOCO) to a matching placebo.
What's involved
Participants will be monitored for adverse events and have their high-sensitivity C-reactive protein (hs-CRP) levels measured from the start of the study to four weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for four weeks after the start of the study.

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NCT06874192

Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Virginia Commonwealth University
~30 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Low-dose colchicine at 0.5mg dailyPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety will be assessed by monitoring the incidence of adverse events
Measured over Baseline to four weeks.
+1 more outcome measured

Conditions

Statin Adverse Reaction

Explore related trials

Statin Intolerance

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Anurag Mehta · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Emily Federmann
[email protected]
804-828-3299
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction
Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month
Patients able to provide informed consent.
Aged 18 to 80 will be enrolled in the study.

Exclusion

Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.
Renal impairment (eGFR \<45 mL/min/1.73 m2)
Transaminitis (ALT or AST \>3 times upper limit of normal)
Cirrhosis
Severe Heart Failure
Active cancer or currently on chemotherapy
Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies
Active infection
Autoimmune or inflammatory condition
Pregnancy or breastfeeding.

What this trial measures

  • Safety will be assessed by monitoring the incidence of adverse eventsBaseline to four weeks.

    Safety will be assessed by monitoring the incidence of adverse events from baseline to four weeks. Adverse events and tolerability will be evaluated using investigator-administered questionnaires at scheduled study visits. Participants will be asked to self-report any symptoms between visits, and all adverse events will be documented.

  • Efficacy will be determined by measuring the change in high-sensitivity C-reactive proteinBaseline to four weeks

    Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline to four weeks. The measurement of hs-CRP pre and post treatment will assess the change in hs-CRP with colchicine. This will test the hypothesis that LODOCO through the inhibition of the inflammatory pathways will lead to a decrease in hs-CRP levels.