Clinical trial Recruiting at 1 site Interventional Ages 18 to 64

Body composition changes with obesity medications, with or without exercise

Official title: Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise

Run by University of Kansas Medical Center · NCT07698145 · Data updated 2026-11-12

This study tests whether adding cardiovascular or resistance exercise to obesity meds helps preserve lean body mass in adults taking obesity drugs.

Quick facts

Study typeInterventional
Ages18 Years to 64 Years
SexAll
Enrollment198 (estimated)
SponsorUniversity of Kansas Medical Center
Academic / other
Locations1 site (Kansas City, Kansas)
StatusRecruiting
StartedJuly 31, 2026
Main results expectedMarch 31, 2030
Study endsMarch 31, 2030
Registry record updatedJuly 15, 2026
Trial IDNCT07698145 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 to under 65 with overweight or obesity (BMI ≥27 with weight-related complications or BMI ≥30 without complications) who are newly prescribed FDA-approved obesity medications and plan to continue treatment for at least 6 months.

Probably not a fit

Individuals who do not experience improvements in lean mass or who cannot participate in prescribed exercise due to safety or feasibility concerns may see no additional benefits.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates how combining pharmacotherapy for obesity with either cardiovascular or resistance exercise affects lean mass retention in adults with overweight or obesity. Participants will be newly prescribed FDA-approved obesity medications and randomized to receive standard medical care plus either cardio exercise, resistance training, or no added exercise, alongside nutrition counseling. The goal is to compare changes in total lean body mass and muscle mass across groups over time, and to explore additional health and fitness benefits of adding exercise to pharmacotherapy. The trial is conducted at the University of Kansas Medical Center with collaboration from NIDDK.

Why it matters

Potential benefit: If successful, participants may experience better preservation of lean mass while losing weight on obesity medications, along with possible improvements in fitness and metabolic health.

How similar studies have gone: Previous work suggests exercise can influence body composition during obesity treatment, but this study adds the specific combination with pharmacotherapy and a direct comparison of exercise modalities.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Both males and females of all race/ethnic groups are eligible for participation in this study.
* 18 to \<65 years of age.
* Newly prescribed FDA-approved obesity manage medication that can include Tirzepatide, Semaglutide, or up to 4 additional next-generation obesity management medications (will receive DSMB approval prior to inclusion), approval for treatment (pharmacy, insurance, etc.), and the participant agreeing to start this treatment and continue treatment for at least 6 months (the participant will be recruited prior to this medication being initiated).
* Body mass index (BMI) of \>=27.0 kg/m2 with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) provided it does not compromise the ability to safely complete the screening or outcome measures or to engage in the prescribed exercise interventions), or \>=30 kg/m2 without weight-related complications. We will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, the participant will be excluded if they exceed the weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition or the MRI that is used to assess muscle quality.
* Ability to provide informed consent prior to participation in this study.
* Clearance from the study physician for meeting all eligibility criteria for this study.

Exclusion Criteria:

* Type 2 diabetes.
* Report moderate-to-vigorous exercise for \>60 min/week, and \>1 day/week of structured cardiovascular or resistance exercise over the past 3 months.
* Report sustained weight loss of \>=3% in the past 3 months.
* History of metabolic/bariatric surgery.
* Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
* Report a current medical condition or treatment for a medical condition that could affect body weight or contradict engagement in any aspect of the outcome measures or interventions.
* History of muscle conditions that may impact the quality of muscle or response to the study interventions (e.g., myopathy, muscular dystrophy, rhabdomyolysis, etc.).
* Contraindications to MRI (e.g., metal implants that are not MRI safe, etc.). NOTE: Participants who are otherwise eligible other than being contraindicated for the MRI scan will be eligible and the MRI scan will not be performed as a research procedure.
* Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction or history of cardiomyopathy, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
* Resting systolic blood pressure of \>=160 mmHg or resting diastolic blood pressure of \>=100 mmHg. If medicated for blood pressure control, the medication dose needs to be stable for \>=6 months.
* Eating disorders that would contraindicate weight loss or physical activity.
* Alcohol or substance abuse.
* Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
* Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.

Where it's running

  • University of Kansas Medical Center
    Kansas City, Kansas, United States
    Recruiting

Study contacts

  • Principal investigator: John M. Jakicic, PhD — University of Kansas Medical Center
  • Study coordinator: John M. Jakicic, PhD
  • Email: jjakicic@kumc.edu
  • Phone: 913-588-9078

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.