What side effects are associated with this type of intervention?

Common treatments for obesity, such as glucagon-like peptide-1 receptor agonists, have been associated with side effects like fatigue, hot flushes, and decreased appetite. Chromium picolinate has shown a relatively small effect on weight reduction with no significant adverse events reported. Colchicine, an anti-inflammatory treatment, is being studied for its potential to improve metabolism in individuals with high body weight and increased inflammation. While specific side effects of colchicine in this context are not detailed, it is generally well-tolerated in other uses but can cause gastrointestinal issues and, rarely, more severe side effects like bone marrow suppression.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide and liraglutide, which are GLP-1 receptor agonists that have shown significant weight loss benefits. These drugs, while primarily used for glycemic control in diabetes, also have anti-inflammatory properties. Another notable drug is orlistat, which works by inhibiting fat absorption in the gut. Although not specifically anti-inflammatory, these treatments contribute to weight loss and can indirectly reduce inflammation associated with obesity.

What other types of research exist?

Promising novel alternatives to colchicine for treating inflammation in obesity patients include tocilizumab and abatacept. These non-TNF-targeted biologics have shown potential in reducing insulin resistance and inflammation in clinical studies. Additionally, lifestyle interventions such as diet and exercise remain foundational approaches.

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Anti-inflammatory

Colchicine for Obesity and Insulin Resistance

Q: What is the mechanism of action of this treatment?

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.

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

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 3 months for reporting.

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 more

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981

Chest pain

Ischemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Colchicine

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

~18130

0 / 10Eligibility criteria met

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.