Statin Adverse ReactionPhase 1NCT06874192
Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
A Phase 1 study testing Low-dose colchicine at 0.5mg daily in people with Statin Adverse Reaction, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Statin Adverse Reaction
- What is being tested?
- Low-dose colchicine at 0.5mg daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2025to 6 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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..
- Conditions
- Statin Adverse Reaction
- Being tested
- Low-dose colchicine at 0.5mg daily, Placebo
- Keywords
- statin intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose colchicine at 0.5mg dailyDrug
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.
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Low-dose colchicine at 0.5mg daily; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: baseline to four weeks
To assess changes in lipid profile from baseline to 30 days
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.
Measured: baseline to four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start12 Mar 2025
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Statin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, double-blind, placebo-controlled, randomized cross-over pilot study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag Mehta, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874192
- Sponsor's protocol ID
- HM20030934
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study
- ClinicalTrials.gov ID
- NCT06874192
- Acronym / sponsor ID
- HM20030934
- Conditions
- Statin Adverse Reaction
- Keywords
- statin intolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single-center, double-blind, placebo-controlled, randomized cross-over pilot study
| Arm | Type | Receives |
|---|---|---|
| Low dose colchicine and then matching placebo | Experimental | Drug: Low-dose colchicine at 0.5mg daily, Other: PlaceboParticipants in this arm will be randomized to receive low-dose colchicine (0.5 mg once daily) and then placebo for 4 weeks |
| Matching placebo and then low dose colchicine | Experimental | Drug: Low-dose colchicine at 0.5mg daily, Other: PlaceboParticipants in this arm will be randomized to receive placebo for 4 weeks and then low-dose colchicine (0.5 mg once daily) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose colchicine at 0.5mg dailyLODOCO 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. | Drug | Low dose colchicine and then matching placebo, Matching placebo and then low dose colchicine |
| PlaceboMatching placebo | Other | Low dose colchicine and then matching placebo, Matching placebo and then low dose colchicine |
Primary outcome
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.
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.
2 secondary outcomes
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 changes in lipid profile from baseline to 30 days
Time frame: baseline to four weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anurag Mehta principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-dose colchicine at 0.5mg daily in people with Statin Adverse Reaction, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be assessed by monitoring the incidence of adverse events (time frame: Baseline to four weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.