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Anti-inflammatory
Colchicine for Obesity and Insulin Resistance
Phase 2
Recruiting
Led By Jack A Yanovski, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Must not have
History of any lymphoproliferative disorder
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 3 months
Awards & highlights
Summary
This trial is testing whether colchicine, a medication usually used for gout, can help improve metabolism in people with high body weight and inflammation. The study focuses on individuals aged 12 and older who have high insulin levels but not high blood sugar. Colchicine aims to reduce inflammation that contributes to insulin resistance and other health problems. Colchicine has been studied for its potential anti-diabetic properties, showing it can significantly reduce blood glucose levels.
Who is the study for?
This trial is for people aged 12 and older who are significantly overweight, with a BMI over 30 kg/m2 for adults or above the 95th percentile for children. They should have signs of inflammation (hsCRP >= 2.0 mg/L) and insulin resistance (HOMA-IR >= 2.6), but not diabetes (HbA1c <=7%). Women must use effective contraception if able to conceive.
What is being tested?
Researchers are testing whether colchicine, an anti-inflammatory medication, can improve metabolism in obese individuals with high levels of inflammation and insulin without high blood sugar yet. Participants will take either colchicine or a placebo daily for up to four months, including check-ins and tests like OGTT.
What are the potential side effects?
Colchicine may cause side effects such as digestive issues (nausea, diarrhea), blood disorders, muscle pain or weakness. Not everyone will experience these side effects; some might have none at all.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old, or I am an adolescent aged 12 to 17.
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My BMI is 30 or higher as an adult, or above the 95th percentile for my age and sex if I'm an adolescent.
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My weight is 450 lbs or less.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a condition where my lymphocytes multiply unusually.
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I have a history of cancer.
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My HbA1c is above 7.0% or I have Type 2 diabetes.
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I am currently taking medication that strongly affects liver enzymes or drug transporters.
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I am not pregnant, planning a pregnancy, breastfeeding, or have irregular periods.
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I regularly use medications like colchicine, diet pills, diabetes drugs, or anti-inflammatory drugs.
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I have recently lost or gained more than 3% of my body weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Homeostatic model assessment of insulin resistance (HOMA-IR)
Secondary study objectives
Change in High-Sensitivity C-Reactive Protein
Change in Matsuda Index
Change in fasting serum glucose
+1 moreSide effects data
From 2021 Phase 4 trial • 280 Patients • NCT017099811%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Colchicine - AdultsExperimental Treatment1 Intervention
Adults given Colchicine 0.6 mg per day (1 capsule per day)
Group II: Colchicine - AdolescentsExperimental Treatment1 Intervention
Adolescents given Colchicine 0.6 mg per day (1 capsule per day)
Group III: Adults no obesity, insulin resistance, or inflammationActive Control1 Intervention
Adults without obesity, insulin resistance or inflammation
Group IV: Adults with obesity, but no insulin resistance/inflammationActive Control1 Intervention
Adults with obesity, but without insulin resistance or inflammation
Group V: Placebo - AdolescentsPlacebo Group1 Intervention
Adolescents given Placebo (1 capsule per day)
Group VI: Placebo - AdultsPlacebo Group1 Intervention
Adults given Placebo (1 capsule per day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
2014
Completed Phase 4
~17930
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity include anti-inflammatory agents like Colchicine, which aim to reduce low-level inflammation associated with obesity and improve metabolic function. Other pharmacological treatments include GLP-1 receptor agonists (e.g., semaglutide), which enhance insulin secretion and reduce appetite, and combination drugs like phentermine-topiramate that suppress appetite and increase energy expenditure.
These treatments are crucial for obesity patients as they target underlying metabolic and inflammatory pathways, helping to reduce body weight, improve insulin sensitivity, and lower the risk of obesity-related comorbidities.
Evaluating the evidence for macrophage presence in skeletal muscle and its relation to insulin resistance in obese mice and humans: a systematic review protocol.New pharmacological tools for obesity.The evaluation of metabolic function and fat redistribution in clinical trials.
Evaluating the evidence for macrophage presence in skeletal muscle and its relation to insulin resistance in obese mice and humans: a systematic review protocol.New pharmacological tools for obesity.The evaluation of metabolic function and fat redistribution in clinical trials.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
2,033 Previous Clinical Trials
2,669,480 Total Patients Enrolled
105 Trials studying Obesity
102,242 Patients Enrolled for Obesity
Jack A Yanovski, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
23 Previous Clinical Trials
6,768 Total Patients Enrolled
14 Trials studying Obesity
3,409 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have major health problems or serious conditions, as decided by the researchers.I am at least 18 years old, or I am an adolescent aged 12 to 17.You have had a serious condition called agranulocytosis, gout, or significant myositis in the past.I have had a condition where my lymphocytes multiply unusually.I have a history of cancer.My HbA1c is above 7.0% or I have Type 2 diabetes.My race, ethnicity, or gender does not exclude me from this trial.I am currently taking medication that strongly affects liver enzymes or drug transporters.I am not pregnant, planning a pregnancy, breastfeeding, or have irregular periods.I am in good health and meet the medication criteria for the study.I haven't had cancer in the last 5 years, except for skin cancer.I am in good health and generally don't take any medications.I regularly use medications like colchicine, diet pills, diabetes drugs, or anti-inflammatory drugs.My BMI is 30 or higher as an adult, or above the 95th percentile for my age and sex if I'm an adolescent.Your insulin resistance level, calculated using a formula with your fasting glucose and insulin levels, is higher than 2.6.You are allergic to colchicine.Criterion: You do not live in the United States.Your hsCRP level is higher than 2.0 mg/L.I am willing to participate in a study and can give consent.You currently have a substance abuse problem or a serious mental health condition.You currently use tobacco or products containing nicotine.My race, ethnicity, or gender does not exclude me from this trial.I am 18 or older with a BMI of 18 or more.My weight is 450 lbs or less.I have recently lost or gained more than 3% of my body weight.You weigh enough for your height.inclusion criteria:
People who will be randomized to colchicine or placebo must meet all of the following inclusion criteria: they must have gout, they must have a flare-up, and they must be willing to take medication.
Research Study Groups:
This trial has the following groups:- Group 1: Adults no obesity, insulin resistance, or inflammation
- Group 2: Adults with obesity, but no insulin resistance/inflammation
- Group 3: Colchicine - Adolescents
- Group 4: Colchicine - Adults
- Group 5: Placebo - Adolescents
- Group 6: Placebo - Adults
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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