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New treatment option for Obesity & Overweight
Official title Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise
ClinicalTrials.gov ID: NCT07698145
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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...
- Body mass index (BMI) of \>=27.0 kg/m2 with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or...
- Ability to provide informed consent prior to participation in this study.
You likely can't join 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...
See the full eligibility 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)...
- 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...
- Ability to provide informed consent prior to participation in this study.
- Clearance from the study physician for meeting all eligibility criteria for this study.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.