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

April 6, 2026 updated by: Virginia Commonwealth University
Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will test the effects of LODOCO in those who have previously been identified as statin intolerant, meaning they are unable to continue taking statins because of side effects. The primary objective of this study is to evaluate the safety and efficacy of low-dose colchicine (LODOCO) in subjects with statin intolerance. Safety will be assessed by monitoring the incidence of adverse events from baseline 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..

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose colchicine and then matching placebo
Participants in this arm will be randomized to receive low-dose colchicine (0.5 mg once daily) and then placebo for 4 weeks
Other: Placebo
Matching placebo
Drug: Low-dose colchicine at 0.5mg daily
LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.
Experimental: Matching placebo and then low dose colchicine
Participants in this arm will be randomized to receive placebo for 4 weeks and then low-dose colchicine (0.5 mg once daily)
Other: Placebo
Matching placebo
Drug: Low-dose colchicine at 0.5mg daily
LODOCO is low-dose colchicine at 0.5mg daily, ii is an FDA approved anti-inflammatory drug, to prevent cardiovascular events in patients with coronary artery disease. LODOCO works by inhibiting microtubule formation and reducing the activity of neutrophils, which play a key role in inflammation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety will be assessed by monitoring the incidence of adverse events
Time Frame: Baseline 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.
Baseline to four weeks.
Efficacy will be determined by measuring the change in high-sensitivity C-reactive protein
Time Frame: Baseline 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.
Baseline to four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the changes in interleukin-6 (IL-6) levels with low-dose colchicine therapy in patients with statin intolerance.
Time Frame: baseline to four weeks
To assess the impact of low dose colchicine on IL-6, we will measure serum IL-6 levels in patients with statin intolerance at baseline and after 30 days of low-dose colchicine therapy. We hypothesize that there will be a significant reduction in IL-6 levels, reflecting a decrease in systemic inflammation.
baseline to four weeks
To assess changes in lipid profile from baseline to 30 days
Time Frame: baseline to four weeks.
To evaluate lipid profile changes in statin-intolerant patients receiving low-dose colchicine by measuring total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides, low-density lipoprotein cholesterol (LDL-C), and lipoprotein(a) [Lp(a)] at baseline and after 30 days of therapy. A 30-day time frame allows for observation of early changes in lipid parameters, which may help guide longer-term studies and inform clinical decision-making.
baseline to four weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Anurag Mehta, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20030934

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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