ObesityPhase 2NCT05017571
Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity
A Phase 2 study testing Colchicine in people with Obesity and Insulin Resistance, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: About 40 percent of adults and 20 percent of adolescents in the U.S. have a body mass index over 30 kg/m2. Being overweight may lead to a state of low-level inflammation. This may cause health problems. Researchers want to see if an anti-inflammatory medicine can help. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Obesity, Insulin Resistance, Inflammation
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 2 Sep 2025
- Phase
- Phase 2
- 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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All races/ethnicities and people of all genders are eligible to participate.
- Participants who will be randomized to colchicine or placebo must meet all of the following
- Good general health. In general subjects should take no medications with the exception of oral/implantable contraceptives, antihypertensive medications like diuretics, or for adults HMG-CoA reductase inhibitors (statin cholesterol-reducing medications). The use of all over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication or have stopped taking an exclusionary medication for at least 3 months prior to study entry may be still eligible.
- Age >= 18y for adults; age 12y to <18y for adolescents
- Obesity BMI >= 30 kg/m2 (adults) or BMI >= 95th percentile for age and sex per Centers for Disease Control Standards (adolescents)
- Weight <= 450 lbs (204.5 kg) - due to DXA limitations
Show all 17Show fewer
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
- HOMA-IR >= 2.6 mg/L, calculated as fasting glucose (in mg/dL) x insulin in (microIU/mL/ 405). Our goal is to enroll participants who have pre-existing insulin resistance.
- hsCRP >= 2.0 mg/L. We aim to recruit participants with increased baseline level of inflammation. Individuals with hsCRP above 2.0 mg/L have been shown to have an increased risk for cardiovascular events.
- Willing to be randomized (willing and able to give consent/assent as required for randomized study).
- Participants who will be evaluated but are not eligible for randomization (Evaluation Only Arm) must meet all of the following Inclusion Criteria:
- Good general health. In general subjects should take no medications. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication or have stopped taking an exclusionary medication for at least 3 months prior to study entry may still be eligible.
- Age >= 18y
- BMI >= 18 kg/m2
- Weight <= 450 lbs (204.5 kg)
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- Willing and able to provide consent for Evaluation-Only study
Who cannot join
- All individuals meeting any of the exclusion criteria at screening or baseline will be excluded from study participation.
- Exclusion Criteria for subject randomized to colchicine or placebo:
- Individuals with significant medical comorbidities (e.g., NYHA Class III or IV heart failure, or CKD Stage 3b or worse (eGFR < 60 mL/min/1.73 m2), or American Society of Anesthesiologists Physical Status Class 3 or above) or other serious disorders at the discretion of the investigators.
- HbA1c > 7.0%
- Type 2 diabetes mellitus, as determined by either having:
- clear clinical diagnosis of diabetes, such as a patient in a hyperglycemic crisis or classic symptoms of hyperglycemia and a random plasma glucose >= 200 mg/dL
Show all 25Show fewer
- two of the following three:
- fasting plasma glucose >= 126 mg/dL
- Hemoglobin A1c >= 6.5%
- An oral glucose tolerance test glucose concentration of >= 200 mg/dL at 2 hours.
- one of the above three criteria (bi.-biii.) meeting the T2DM cutoff on two different days.
- If only one of the above three criteria (bi.-biii.) meet the T2DM threshold during the Screening Visit, that test will be repeated on another day to determine if the subject has T2DM or not. As per ADA guidelines, The diagnosis [of T2DM] is made on the basis of the confirmed test.
- Moreover, because HbA1c has been shown to be higher in African Americans (AA) as compared to other races for the same glycemia, AA who do not have diabetes may be unfairly excluded by their HbA1c alone 96-98. Therefore, for AA subjects, if their fasting and 2h glucose is in the non-diabetes range, and the HbA1c is < 7.0%, we will consider them not to have diabetes.
- Recent or regular use of colchicine, anorexiant, or diabetic medications in the last 3 months, or plan to start in the following 3 months.
- Recent or regular use of anti-inflammatory medications (e.g. prednisone, NSAIDs) in the last 7 days, or plan to start in the following 3 months.
- Current use of a strong or moderate CYP3A4 inhibitor or P-glycoprotein (P-gp), as this may cause a significant increase in colchicine plasma concentrations and risk for side effects. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. Note: HMA-CoA reductase inhibitors ( statins ) in adults only will also be
- explicitly allowed because of the recent clinical trial data finding it is safe to administer low-dose colchicine even with high-dose statin therapy. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication or have stopped taking an exclusionary medication for at least 3 months prior to study entry may be eligible.
- Known allergy to colchicine.
- Previous history of agranulocytosis, gout, or significant myositis.
- Females who are pregnant, planning to become pregnant, currently nursing an infant, or have irregular menses, defined as cycles less than 21 days or greater than 45 days in premenopausal women.
- Individuals who have current substance abuse or a DSM 5 Axis I psychiatric disorder or DSM Axis II Mental Retardation diagnosis that in the opinion of the investigators would impede competence, compliance, or participation in the study.
- Current users of tobacco or nicotine (e.g., nicotine patch, e-cigarettes) products.
- Participation in a formal weight loss program (e.g., Weight Watchers) or recent weight change of more than 3% of body weight in the past two months.
- Exclusion Criteria for subjects who are evaluated but not eligible for randomization (Evaluation Only Arm):
- We will use the same exclusion criteria as employed for randomized participants (see above).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: COLSIO Trial: Phase II Randomized, Controlled Trial of Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity
Background:
About 40 percent of adults and 20 percent of adolescents in the U.S. have a body mass index over 30 kg/m2. Being overweight may lead to a state of low-level inflammation. This may cause health problems. Researchers want to see if an anti-inflammatory medicine can help.
Read more
Objective:
To learn if colchicine can improve metabolism in people who have high body weight, increased inflammation, and high insulin in the blood but who have not yet developed high blood sugar.
Eligibility:
People aged 12 and older with high body weight who may have increased inflammation and high insulin in the blood. Healthy adult volunteers are also needed.
Design:
Participants will be screened with the following:
Medical history
Physical exam
Fasting blood tests
Urine tests
Electrocardiogram
Dual energy x-ray absorptiometry (They will lie on a table while a camera passes over their body.)
Stool sample and 24-hour food diary (optional)
Participants will have 3 study visits and 3 phone check-ins. At visits, they will repeat some screening tests.
Healthy volunteers will have the baseline visit only. They will not get the study drug.
At the baseline visit, participants will have an Oral Glucose Tolerance Test (OGTT). For this, they will drink a sweet liquid and then give blood samples. They will get a 12-week supply of the study drug or placebo to take daily by mouth.
Participants will have study visits 6 weeks and 12 weeks after they started taking the study drug. At the 12-week visit, they will repeat the OGTT.
Participation will last for 3 (Omega) to 4 months.
...
Read the detailed description
Study Description:
Obesity affects more than 40% of the adult U.S. population plus approximately 20% of adolescents and is a major risk factor for the development of type 2 diabetes and cardiovascular disease. Mouse models and human data suggest that obesity-induced chronic inflammation is one mechanism promoting obesity-associated comorbid conditions. In obesity, innate immunity is activated when circulating molecules such as fatty acids and cholesterol crystals bind to nucleotide-binding oligomerization (Nod)-like receptor family, pyrin domain containing 3 (NLRP3) receptors. The resultant inflammatory cascade leads to insulin resistance and decreased pancreatic beta-cell reserve. It has been proposed that the suppression of this chronic low-level inflammatory state may impede the onset of diabetes and cardiovascular disease.
Recent studies have shown colchicine, a potent microtubule inhibitor that is approved for use in the treatment of gout and some rare inflammatory conditions in adults and children, disrupts intracellular NLRP3 inflammasome assembly. As there are limited medical therapies proven effective to improve obesity-related metabolic dysregulation, we propose to determine the efficacy of oral colchicine 0.6 mg versus placebo once daily in non-diabetic adults and adolescents with obesity, insulin resistance, and inflammation (elevated high-sensitivity C-reactive protein concentrations: hsCRP >= 2.0). From among up to 500 individuals screened, we will conduct a randomized, double-blind, placebo-controlled trial of colchicine in up to 200 adults. We will also obtain pilot data from 40 adolescents studied in the same (randomized) fashion. This study will determine the effects of colchicine on insulin resistance and beta cell reserve in adults with obesity and allow determination of the sample size needed to conduct an adequately powered study of the effects of colchicine in adolescents. An Evaluation-Only control group of up to 50 adults who do not meet entry criteria for the randomized clinical trial will also be studied with baseline tests only.
Objectives:
Primary Objective:
To compare efficacy of colchicine versus placebo for improving insulin resistance in adults with obesity-related inflammation
Secondary Objectives:
To compare the effect of colchicine versus placebo on other biomarkers of metabolic health, inflammation, and colchicine action in adults with obesity-related inflammation
To determine effect sizes for colchicine versus placebo in adolescents with obesity-related inflammation for insulin resistance as well as other biomarkers of metabolic health, inflammation, and colchicine action
Additional Objectives:
To compare the effect of colchicine versus placebo on changes in the secretome and stool microbiome in adults with obesity-related inflammation.
To examine if there are sex x treatment or race/ethnicity x treatment interactions for the effects of colchicine on change in insulin resistance and other biomarkers in adults with obesity-related inflammation.
To compare the effect of colchicine versus placebo on changes in hepatic gluconeogenesis and triglyceride synthesis rate indices in adults with obesity-related inflammation.
Endpoints:
Primary Endpoint:
Change in homeostatic model assessment of insulin resistance (HOMA-IR) from baseline (randomization) to 3 months in adult participants
Key Secondary Endpoints:
Changes from baseline (randomization) to 3 months in high sensitivity C-reactive protein (hsCRP), Matsuda index, fasting serum glucose and insulin in adult participants.
Additional (Exploratory) Study Endpoints:
Changes from baseline (randomization) to 3 months in muscle insulin resistance index, adipose insulin resistance index (Adipo-IR), pancreatic beta cell indices (e.g. HOMA-B%, insuligenic index), triglycerides, LDL- and HDL-cholesterol, lipoprotein profile, liver fat content, systolic and diastolic blood pressure, oral glucose tolerance test (OGTT) or oral sugar tolerance test (OSTT) area under the curve (AUC) insulin and glucose, AUC insulin/AUC glucose ratio, hepatic gluconeogenesis and triglyceride synthesis rate indices, other inflammatory and metabolic markers, secretome, and microbiome analyses in adult participants.
Post-hoc power calculation of sample size needed, at power >= 80% and two-sided alpha <= 0.05 for change in HOMA-IR in adolescent participants. In adolescent participants, changes from baseline (randomization) to 3 months in HOMA-IR, hsCRP, Matsuda index, muscle insulin resistance index, Adipo-IR, OGTT AUC insulin and glucose, AUC insulin/AUC glucose ratio, pancreatic beta cell indices (e.g., HOMAB%, insuligenic index), fasting serum glucose, insulin, triglycerides, LDL- and HDL-cholesterol, lipoprotein profile, systolic and diastolic blood pressure, inflammatory and metabolic markers, secretome, and microbiome analyses.
- Conditions
- Obesity, Insulin Resistance, Inflammation
- Being tested
- Colchicine, Placebo
- Keywords
- Diabetes, Overweight, comorbidities, Microbiome, C-Reactive Protein
- Medical subject headings
- Obesity, Insulin Resistance, Inflammation, Diabetes Mellitus, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 1 capsule (0.6 mg) per day
PlaceboDrug
Placebo 1 capsule per day
| Study group | Role | What they receive |
|---|---|---|
| Adults no obesity, insulin resistance, or inflammation | No intervention | Adults without obesity, insulin resistance or inflammation |
| Adults with obesity, but no insulin resistance/inflammation | No intervention | Adults with obesity, but without insulin resistance or inflammation |
| Colchicine - Adolescents | Experimental | Adolescents given Colchicine 0.6 mg per day (1 capsule per day) Receives: Drug: Colchicine |
| Colchicine - Adults | Experimental | Adults given Colchicine 0.6 mg per day (1 capsule per day) Receives: Drug: Colchicine |
| Placebo - Adolescents | Placebo comparator | Adolescents given Placebo (1 capsule per day) Receives: Drug: Placebo |
| Placebo - Adults | Placebo comparator | Adults given Placebo (1 capsule per day) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Homeostatic model assessment of insulin resistance (HOMA-IR)
HOMA-IR is calculated from fasting (f) insulin (I) and glucose (G): Gf (in mg/dL) x If in ( (Micro)IU/mL/ 405).
Measured: From baseline to 3 months
Secondary outcomes (4)
Change in fasting serum insulin
Fasting serum insulin
Measured: From baseline to 3 months
Change in fasting serum glucose
Fasting serum glucose
Measured: From baseline to 3 months
Change in High-Sensitivity C-Reactive Protein
High-Sensitivity C-Reactive Protein
Measured: From baseline to 3 months
Change in Matsuda Index
(10^4/([Gf x 18] x If x [mean GOSTTx18] x mean I-OSTT)0.5), where Gf is fasting glucose, If is fasting insulin, and I-OSTT is mean insulin from oral sugar tolerance test
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start8 Nov 2021
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017571
- Sponsor's protocol ID
- 10000235
- Other IDs
- 000235-CH
- Status last verified
- 3 Sep 2025
- First submitted
- 21 Aug 2021
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD are to be shared.
Publications
Demidowich AP, Davis AI, Dedhia N, Yanovski JA. Colchicine to decrease NLRP3-activated inflammation and improve obesity-related metabolic dysregulation. Med Hypotheses. 2016 Jul;92:67-73. doi: 10.1016/j.mehy.2016.04.039. Epub 2016 Apr 25.
PubMed 27241260Demidowich AP, Levine JA, Apps R, Cheung FK, Chen J, Fantoni G; CHI Consortium; Patel TP, Yanovski JA. Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial. Int J Obes (Lond). 2020 Aug;44(8):1793-1799. doi: 10.1038/s41366-020-0598-3. Epub 2020 May 27.
PubMed 32461554Demidowich AP, Levine JA, Onyekaba GI, Khan SM, Chen KY, Brady SM, Broadney MM, Yanovski JA. Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial. Diabetes Obes Metab. 2019 Jul;21(7):1642-1651. doi: 10.1111/dom.13702. Epub 2019 Apr 2.
PubMed 30869182
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLSIO Trial: Phase II Randomized, Controlled Trial of Colchicine to Suppress Inflammation and Improve Insulin Resistance in Adults and Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT05017571
- Acronym / sponsor ID
- 10000235
- Conditions
- Obesity, Insulin Resistance, Inflammation
- Keywords
- Diabetes, Overweight, comorbidities, Microbiome, C-Reactive Protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 24 Aug 2021 (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.
Background:
About 40 percent of adults and 20 percent of adolescents in the U.S. have a body mass index over 30 kg/m2. Being overweight may lead to a state of low-level inflammation. This may cause health problems. Researchers want to see if an anti-inflammatory medicine can help.
Objective:
To learn if colchicine can improve metabolism in people who have high body weight, increased inflammation, and high insulin in the blood but who have not yet developed high blood sugar.
Eligibility:
People aged 12 and older with high body weight who may have increased inflammation and high insulin in the blood. Healthy adult volunteers are also needed.
Design:
Participants will be screened with the following:
Medical history
Physical exam
Fasting blood tests
Urine tests
Electrocardiogram
Dual energy x-ray absorptiometry (They will lie on a table while a camera passes over their body.)
Stool sample and 24-hour food diary (optional)
Participants will have 3 study visits and 3 phone check-ins. At visits, they will repeat some screening tests.
Healthy volunteers will have the baseline visit only. They will not get the study drug.
At the baseline visit, participants will have an Oral Glucose Tolerance Test (OGTT). For this, they will drink a sweet liquid and then give blood samples. They will get a 12-week supply of the study drug or placebo to take daily by mouth.
Participants will have study visits 6 weeks and 12 weeks after they started taking the study drug. At the 12-week visit, they will repeat the OGTT.
Participation will last for 3 (Omega) to 4 months.
...
Detailed description
Study Description:
Obesity affects more than 40% of the adult U.S. population plus approximately 20% of adolescents and is a major risk factor for the development of type 2 diabetes and cardiovascular disease. Mouse models and human data suggest that obesity-induced chronic inflammation is one mechanism promoting obesity-associated comorbid conditions. In obesity, innate immunity is activated when circulating molecules such as fatty acids and cholesterol crystals bind to nucleotide-binding oligomerization (Nod)-like receptor family, pyrin domain containing 3 (NLRP3) receptors. The resultant inflammatory cascade leads to insulin resistance and decreased pancreatic beta-cell reserve. It has been proposed that the suppression of this chronic low-level inflammatory state may impede the onset of diabetes and cardiovascular disease.
Recent studies have shown colchicine, a potent microtubule inhibitor that is approved for use in the treatment of gout and some rare inflammatory conditions in adults and children, disrupts intracellular NLRP3 inflammasome assembly. As there are limited medical therapies proven effective to improve obesity-related metabolic dysregulation, we propose to determine the efficacy of oral colchicine 0.6 mg versus placebo once daily in non-diabetic adults and adolescents with obesity, insulin resistance, and inflammation (elevated high-sensitivity C-reactive protein concentrations: hsCRP >= 2.0). From among up to 500 individuals screened, we will conduct a randomized, double-blind, placebo-controlled trial of colchicine in up to 200 adults. We will also obtain pilot data from 40 adolescents studied in the same (randomized) fashion. This study will determine the effects of colchicine on insulin resistance and beta cell reserve in adults with obesity and allow determination of the sample size needed to conduct an adequately powered study of the effects of colchicine in adolescents. An Evaluation-Only control group of up to 50 adults who do not meet entry criteria for the randomized clinical trial will also be studied with baseline tests only.
Objectives:
Primary Objective:
To compare efficacy of colchicine versus placebo for improving insulin resistance in adults with obesity-related inflammation
Secondary Objectives:
To compare the effect of colchicine versus placebo on other biomarkers of metabolic health, inflammation, and colchicine action in adults with obesity-related inflammation
To determine effect sizes for colchicine versus placebo in adolescents with obesity-related inflammation for insulin resistance as well as other biomarkers of metabolic health, inflammation, and colchicine action
Additional Objectives:
To compare the effect of colchicine versus placebo on changes in the secretome and stool microbiome in adults with obesity-related inflammation.
To examine if there are sex x treatment or race/ethnicity x treatment interactions for the effects of colchicine on change in insulin resistance and other biomarkers in adults with obesity-related inflammation.
To compare the effect of colchicine versus placebo on changes in hepatic gluconeogenesis and triglyceride synthesis rate indices in adults with obesity-related inflammation.
Endpoints:
Primary Endpoint:
Change in homeostatic model assessment of insulin resistance (HOMA-IR) from baseline (randomization) to 3 months in adult participants
Key Secondary Endpoints:
Changes from baseline (randomization) to 3 months in high sensitivity C-reactive protein (hsCRP), Matsuda index, fasting serum glucose and insulin in adult participants.
Additional (Exploratory) Study Endpoints:
Changes from baseline (randomization) to 3 months in muscle insulin resistance index, adipose insulin resistance index (Adipo-IR), pancreatic beta cell indices (e.g. HOMA-B%, insuligenic index), triglycerides, LDL- and HDL-cholesterol, lipoprotein profile, liver fat content, systolic and diastolic blood pressure, oral glucose tolerance test (OGTT) or oral sugar tolerance test (OSTT) area under the curve (AUC) insulin and glucose, AUC insulin/AUC glucose ratio, hepatic gluconeogenesis and triglyceride synthesis rate indices, other inflammatory and metabolic markers, secretome, and microbiome analyses in adult participants.
Post-hoc power calculation of sample size needed, at power >= 80% and two-sided alpha <= 0.05 for change in HOMA-IR in adolescent participants. In adolescent participants, changes from baseline (randomization) to 3 months in HOMA-IR, hsCRP, Matsuda index, muscle insulin resistance index, Adipo-IR, OGTT AUC insulin and glucose, AUC insulin/AUC glucose ratio, pancreatic beta cell indices (e.g., HOMAB%, insuligenic index), fasting serum glucose, insulin, triglycerides, LDL- and HDL-cholesterol, lipoprotein profile, systolic and diastolic blood pressure, inflammatory and metabolic markers, secretome, and microbiome analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adults no obesity, insulin resistance, or inflammation | No intervention | –Adults without obesity, insulin resistance or inflammation |
| Adults with obesity, but no insulin resistance/inflammation | No intervention | –Adults with obesity, but without insulin resistance or inflammation |
| Colchicine - Adolescents | Experimental | Drug: ColchicineAdolescents given Colchicine 0.6 mg per day (1 capsule per day) |
| Colchicine - Adults | Experimental | Drug: ColchicineAdults given Colchicine 0.6 mg per day (1 capsule per day) |
| Placebo - Adolescents | Placebo comparator | Drug: PlaceboAdolescents given Placebo (1 capsule per day) |
| Placebo - Adults | Placebo comparator | Drug: PlaceboAdults given Placebo (1 capsule per day) |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- All races/ethnicities and people of all genders are eligible to participate.
- Participants who will be randomized to colchicine or placebo must meet all of the following
- Good general health. In general subjects should take no medications with the exception of oral/implantable contraceptives, antihypertensive medications like diuretics, or for adults HMG-CoA reductase inhibitors (statin cholesterol-reducing medications). The use of all over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication or have stopped taking an exclusionary medication for at least 3 months prior to study entry may be still eligible.
- Age >= 18y for adults; age 12y to <18y for adolescents
- Obesity BMI >= 30 kg/m2 (adults) or BMI >= 95th percentile for age and sex per Centers for Disease Control Standards (adolescents)
Key exclusion criteria (25 listed)
- All individuals meeting any of the exclusion criteria at screening or baseline will be excluded from study participation.
- Individuals with significant medical comorbidities (e.g., NYHA Class III or IV heart failure, or CKD Stage 3b or worse (eGFR < 60 mL/min/1.73 m2), or American Society of Anesthesiologists Physical Status Class 3 or above) or other serious disorders at the discretion of the investigators.
- HbA1c > 7.0%
- Type 2 diabetes mellitus, as determined by either having:
- If only one of the above three criteria (bi.-biii.) meet the T2DM threshold during the Screening Visit, that test will be repeated on another day to determine if the subject has T2DM or not. As per ADA guidelines, The diagnosis [of T2DM] is made on the basis of the confirmed test.
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 |
|---|---|---|
| ColchicineColchicine 1 capsule (0.6 mg) per day | Drug | Colchicine - Adolescents, Colchicine - Adults |
| PlaceboPlacebo 1 capsule per day | Drug | Placebo - Adolescents, Placebo - Adults |
Primary outcome
Change in Homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: From baseline to 3 months
HOMA-IR is calculated from fasting (f) insulin (I) and glucose (G): Gf (in mg/dL) x If in ( (Micro)IU/mL/ 405).
4 secondary outcomes
Change in fasting serum insulin
Time frame: From baseline to 3 months
Change in fasting serum glucose
Time frame: From baseline to 3 months
Change in High-Sensitivity C-Reactive Protein
Time frame: From baseline to 3 months
Change in Matsuda Index
Time frame: From baseline to 3 months
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 5 Sep 2025.
- Background: PubMed 27241260Demidowich AP, Davis AI, Dedhia N, Yanovski JA. Colchicine to decrease NLRP3-activated inflammation and improve obesity-related metabolic dysregulation. Med Hypotheses. 2016 Jul;92:67-73. doi: 10.1016/j.mehy.2016.04.039. Epub 2016 Apr 25.
- Background: PubMed 32461554Demidowich AP, Levine JA, Apps R, Cheung FK, Chen J, Fantoni G; CHI Consortium; Patel TP, Yanovski JA. Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial. Int J Obes (Lond). 2020 Aug;44(8):1793-1799. doi: 10.1038/s41366-020-0598-3. Epub 2020 May 27.
- Background: PubMed 30869182Demidowich AP, Levine JA, Onyekaba GI, Khan SM, Chen KY, Brady SM, Broadney MM, Yanovski JA. Effects of colchicine in adults with metabolic syndrome: A pilot randomized controlled trial. Diabetes Obes Metab. 2019 Jul;21(7):1642-1651. doi: 10.1111/dom.13702. Epub 2019 Apr 2.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD are to be shared.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Obesity and Insulin Resistance, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 17 inclusion and 25 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 5 Sep 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Homeostatic model assessment of insulin resistance (HOMA-IR) (time frame: From baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017571, which also lists 3 linked publications.
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 5 Sep 2025.