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

NCT07698145 | Recruiting DMC

• 2 other identifiers: STUDY00161746R01DK141779-01A1
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Obesity & Overweight

Keywords

overweight; obesity; exercise; physical activity; pharmacotherapy; body composition

Outcome Measures

Primary Outcomes (1)

• Lean body mass

  Lean Body Mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).

  0 and 6 months

Secondary Outcomes (23)

• Muscle Mass

  0 and 6 months

• Muscle Quality

  0 and 6 months

• Body Weight

  0 months, week 6, week 12, week 18, 6 months

• Body Mass Index

  0 months, week 6, week 12, week 18, 6 months

• Percent body fat

  0 and 6 months

Other Outcomes (5)

• Medication Reporting

  0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21

• Obesity Management Medication Adherence

  0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21

• Demographic Characteristics

  0 months

Study Arms (3)

Standard Care with an Obesity Management Medication

EXPERIMENTAL

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.

Other: Standard Medical Care with an Obesity Management Medication; Behavioral: Nutrition Counseling

Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training

EXPERIMENTAL

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.

Other: Standard Medical Care with an Obesity Management Medication; Behavioral: Cardiovascular Exercise Training; Behavioral: Nutrition Counseling

Standard Care with an Obesity Management Medication Plus Resistance Exercise Training

EXPERIMENTAL

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.

Other: Standard Medical Care with an Obesity Management Medication; Behavioral: Resistance Exercise Training; Behavioral: Nutrition Counseling

Interventions

Standard Medical Care with an Obesity Management Medication OTHER

Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.

Standard Care with an Obesity Management Medication; Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training; Standard Care with an Obesity Management Medication Plus Resistance Exercise Training

Cardiovascular Exercise Training BEHAVIORAL

Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.

Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training

Resistance Exercise Training BEHAVIORAL

Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.

Standard Care with an Obesity Management Medication Plus Resistance Exercise Training

Nutrition Counseling BEHAVIORAL

Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.

Standard Care with an Obesity Management Medication; Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training; Standard Care with an Obesity Management Medication Plus Resistance Exercise Training

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both males and females of all race/ethnic groups are eligible for participation in this study.
• to \<65 years of age.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John M. Jakicic, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Renee J. Rogers, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M. Jakicic, PhD

CONTACT

913-588-9078; jjakicic@kumc.edu

Renee J. Rogers, PhD

CONTACT

913-588-8580; rrogers10@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 13, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: July 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be made available no later than the time of an associated publication of study outcomes or at the end of the performance period, whichever comes first. The data provided to the repository will be available indefinitely while that repository continues to exist.
• Access Criteria: The information included with the IPD will be made available to appropriate individuals only after the requester confirms their willingness to comply with an appropriate "Data Use Agreement" that complies with NIH policies, the policies of the institution where the study has been conducted, and the elements of informed consent.

Locations

US (1)