Recruiting
Phase 1

LODOCO

Sponsor:

Virginia Commonwealth University

Code:

NCT06874192

Conditions

Statin Adverse Reaction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low-dose colchicine at 0.5mg daily

Placebo

Study Details

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

Study ID

NCT06874192

Start date

Mar 12, 2025

Status verified date

Jun, 2026

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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)

Interventions

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.

Placebo

Matching placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Emily Federmann

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

Joshua West

804.628.3981Joshua.West@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Pamela Alebna

804-828-9989pamela.alebna@vcuhealth.org

Anurag Mehta

(804) 828-9989anurag.mehta@vcuhealth.org

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • statin intolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-07-01.