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Anti-Obesity Medication

Anti-Obesity Medications for Obesity (M3 Trial)

N/A

Recruiting

Led By Renee J. Rogers, Ph.D.

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Randomized Study: Adults aged 18 to <60 years. For Observational Study: Adults aged >60 years.

BMI >27.0 kg/m2 with at least one weight-related complication, or >30 kg/m2 without weight-related complications.

Must not have

History of metabolic/bariatric surgery.

History of muscle conditions impacting muscle quality or response to study interventions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 and 6 months; 6, 12, 18 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how obesity medication impacts body composition and if aerobic or resistance exercise training affects these changes. It will also look at how exercise impacts other health and fitness factors. The trial will compare

Who is the study for?

This trial is for individuals with obesity who are interested in understanding how different types of exercise and standard medical care can affect their body composition, fitness, physical activity levels, muscle strength, blood pressure, food intake, and overall quality of life over a 6-month period.

What is being tested?

The study compares the effects of no exercise/standard medical care to supervised aerobic or resistance training on various health metrics. Participants will be monitored regularly and engage in exercise sessions three times a week if assigned to an exercise group.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical risks associated with starting an exercise program such as muscle soreness or strain. Standard Medical Care might have side effects depending on the specific treatments involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18-59 years old for a study or over 60 for an observational study.

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My BMI is over 27 with health issues related to weight, or over 30 without them.

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I am starting a new obesity treatment with AOM and agree to continue for 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I have muscle conditions that could affect my response to treatment.

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I have type 2 diabetes.

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I have lost more than 3% of my weight in the last 3 months.

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I do not have serious heart conditions or require chronic blood thinners.

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I am not pregnant, have not been pregnant in the last 6 months, and do not plan to become pregnant during the study.

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I have not been hospitalized for mental health issues in the past year and my treatment has been stable for 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 and 6 months; 6, 12, 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 and 6 months; 6, 12, 18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 6 months; 6, 12, 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lean Body Mass

Secondary study objectives

Body Fat Mass

Body Height

Body Mass Index

+11 more

Other study objectives

Adverse and Serious Adverse Events

Demographic Characteristics

Lifestyle and Health History

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard Medical Care plus Resistance TrainingExperimental Treatment4 Interventions

Standard Medical Care plus Resistance Training will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive supervised resistance exercise in addition to brief contacts from the research staff at weeks 6, 12, and 18.

Group II: Standard Medical Care plus Aerobic TrainingExperimental Treatment4 Interventions

Standard Medical Care plus Aerobic Training will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive supervised aerobic exercise in addition to brief contacts from the research staff at weeks 6, 12, and 18.

Group III: Standard Medical CareActive Control3 Interventions

Standard Medical Care will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief contacts from the research staff at weeks 6, 12, and 18.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Training

2024

N/A

~880

Resistance Training

2019

Completed Phase 2

~1230