Exercise added to weight-loss medicine to help keep muscle in adults with obesity
Tests adding cardio or strength exercise to obesity medicine, looking at muscle retention.
Key facts
- Who runs it
- University of Kansas Medical Center
- Where
- Kansas City, United StatesSee the site
- Trial code
- Registry title
- Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise
- Status
- Recruiting
- People taking part
- 198 people, planned
- Started
- 31 Jul 2026
- Expected to end
- 31 Mar 2030
- Type of study
- Interventional, 3 groups
- Treatments tested
- Standard Medical Care with an Obesity Management Medication
- Cardiovascular Exercise Training
- Resistance Exercise Training
- Nutrition Counseling
- Record updated
- 15 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with overweight or obesity who are about to start an obesity medication prescribed by their own doctor. It tests whether adding exercise helps keep lean body mass.
- Age
- 18 to under 65 years (up to 64 years).
- Sex
- Men and women can both join.
- Disease stage
- BMI of 27.0 kg/m2 or more with at least one weight-related problem (high blood pressure, abnormal blood fats, sleep apnea or heart disease), or BMI of 30 kg/m2 or more without such problems.
- Earlier treatment
- Must be newly prescribed an obesity medication such as Tirzepatide or Semaglutide, and agree to take it for at least 6 months. Must not have had metabolic/bariatric surgery.
Main reasons for not taking part
- Type 2 diabetes
- Regular exercise: more than 60 min/week of moderate-to-vigorous exercise and more than 1 day/week of structured exercise in the past 3 months
- Weight loss of 3% or more in the past 3 months
- Pregnant, breastfeeding or planning pregnancy during the study
- Heart conditions such as heart failure, angina or a past heart attack
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Type 2 diabetes
- History of metabolic/bariatric surgery
- 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.)
- Eating disorders that would contraindicate weight loss or physical activity
- 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 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
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period
- Alcohol or substance abuse
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in United States
- University of Kansas Medical CenterKansas City, United StatesContact: John M. Jakicic, PhDTaking people
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment by their personal physician. It will also provide information about whether either form of exercise added to pharmacotherapy for obesity treatment has additional benefits on other health and fitness measurements. The main questions it aims to answer are:
Read full original descriptionShow less
* Is there a difference in the change in total lean body mass between pharmacotherapy alone and either pharmacotherapy plus cardiovascular exercise or pharmacotherapy plus resistance exercise? * Is there a difference in the change in muscle mass between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in muscle quality between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in body weight between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in body composition (fat mass, fat mass distribution) between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in cardiorespiratory fitness between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in muscle strength between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in physical function between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in bone mineral density between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in bone biomarkers between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in resting blood pressure between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in energy intake between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there a difference in the change in physical activity between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)? * Is there an effect of sex, race/ethnicity, age, menopausal status, obesity management medication type, or other demographic characteristics on the outcomes that are being measured. * What is the extent to which the retention of lean body mass or muscle mass mediates the effect of exercise on weight changes.
Participants will:
* Initiate and continue throughout the study period an eligible obesity management medication that is prescribed by their healthcare provider, and to report their adherence to this medication to the investigators. * Participant in this study for a period of 6-8 months to complete outcome assessments that occur at baseline and at the conclusion of 6 months of the intervention period, and monitoring visits that occur at weeks 3, 6, 9, 12, 15, 18, and 21. * If attend 3 supervised exercise sessions per week if assigned to either the cardiovascular exercise intervention or the resistance training intervention for a period of 24 weeks.
The 3 groups in the trial
- Standard Care with an Obesity Management MedicationTreatment being tested
Participants will receive standard medical care from their personal physician related to their obesity management medication for a period of 6 months. Progression of this medication will be monitored as part of the participation in this study. Participants will undergo screening and baseline assessments prior to initiating the use of the medication and after a period of 6 months. Upon randomization, participants will receive a "Nutrition 101" session where dietary considerations while taking this medication will be discussed. We will also have a brief contact (weeks 3, 6, 9, 12, 15, 18, and 21) with the participant to monitor changes in weight, blood pressure, health status, and medication adherence and use (including the dose of the obesity management medication that they have been prescribed). Participants will be instructed to maintain their current level of physical activity throughout the 6-month study period.
Treatment: Standard Medical Care with an Obesity Management Medication and Nutrition Counseling
- Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise TrainingTreatment being tested
Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised cardiovascular exercise training. This will occur on 3 days per week and will progress to 50 minutes per session (150 minutes per week). The intensity of the exercise will progress from 60%±5% to 70%±5% of age-predicted maximal heart rate (if taking beta-blocker medication intensity will progress from a Rating of Perceived Exertion of 11-13 to 12-14 based on the 6-20 Borg scale). While walking will be the preferred mode of exercise, we will allow for alternative forms of cardiovascular exercise (upright or recumbent cycling, elliptical, etc.) to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions.
Treatment: Standard Medical Care with an Obesity Management Medication, Cardiovascular Exercise Training, and Nutrition Counseling
- Standard Care with an Obesity Management Medication Plus Resistance Exercise TrainingTreatment being tested
Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised resistance exercise training. This will occur 3 days per week and involve 9 different exercises. Each exercise will progress to 3 sets with a rest period of 60 to 90 seconds between each set. Warm-up sets will include 10 repetitions, and all remaining sets will perform repetitions until volitional fatigue. Heart rate will be monitored throughout these exercise sessions.
Treatment: Standard Medical Care with an Obesity Management Medication, Resistance Exercise Training, and Nutrition Counseling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise
- Plain-language title
- Exercise added to weight-loss medicine to help keep muscle in adults with obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07698145, who can take part
- Record updated
- 15 July 2026