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

NCT06874192 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HM20030934
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Statin Adverse Reaction

Keywords

statin intolerance

Outcome Measures

Primary Outcomes (2)

• Safety will be assessed by monitoring the incidence of adverse events

  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

  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 Outcomes (2)

• To investigate the changes in interleukin-6 (IL-6) levels with low-dose colchicine therapy in patients with statin intolerance.

  baseline to four weeks

• To assess changes in lipid profile from baseline to 30 days

  baseline to four weeks.

Study Arms (2)

Low dose colchicine and then matching placebo

EXPERIMENTAL

Participants in this arm will be randomized to receive low-dose colchicine (0.5 mg once daily) and then placebo for 4 weeks

Drug: Low-dose colchicine at 0.5mg daily; Other: Placebo

Matching placebo and then low dose colchicine

EXPERIMENTAL

Participants in this arm will be randomized to receive placebo for 4 weeks and then low-dose colchicine (0.5 mg once daily)

Drug: Low-dose colchicine at 0.5mg daily; Other: Placebo

Interventions

Low-dose colchicine at 0.5mg daily DRUG

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.

Low dose colchicine and then matching placebo; Matching placebo and then low dose colchicine

Placebo OTHER

Matching placebo

Low dose colchicine and then matching placebo; Matching placebo and then low dose colchicine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• Anurag Mehta

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Federmann

CONTACT

804-828-3299; Emily.Federmann@vcuhealth.org

Joshua West

CONTACT

804.628.3981; Joshua.West@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomized in a 1:1 ratio to receive either low-dose colchicine (0.5 mg once daily) or matching placebo for 4 weeks.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, double-blind, placebo-controlled, randomized cross-over pilot study

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)