The Effects of Semaglutide on Body Composition and Performance in Military Personnel
NCT Number: NCT06468748
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Obesity
Interventions: DRUG: Semaglutide
Sponsor: United States Army Research Institute of Environmental Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2028-09

Summary:
The obesity epidemic presents a growing concern in the United States, affecting more than 42% of adults. This epidemic extends its impact to chronic diseases and escalating healthcare expenses. Its reach has even influenced the military, with more than 20% of Soldiers being classified as obese, based on Body Mass Index ≥30 kg/m2. Current preventative and countermeasures have produced limited success, prompting consideration of pharmacotherapy. Within this context, glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, have emerged as a promising treatment for obesity. Semaglutide can induce significant weight loss, primarily through fat reduction. However, questions persist regarding its effects on lean mass, physical performance, bone structure, and how it influences the underlying metabolic and hormonal milieu. Furthermore, no studies have been completed in military personnel, who must exercise regularly. Therefore, the investigators will conduct a single-center, open-label, observational trial. The trial will consist of a 24-week semaglutide treatment period and a non-treated 52-week follow-up period. We will test the feasibility and potential benefits of semaglutide in military populations, with a focus on understanding how semaglutide influences body composition, physical performance, hormones, and metabolism. This research holds military significance as obesity rates among service members continue to rise, undermining their medical readiness. Ultimately, it is important to understand if GLP-1RAs can provide a viable solution to obesity in military personnel and if there might be an unexpected effect on physical readiness due to the nature of the weight loss. This could cut down on healthcare expenses by reducing the reliance on weight-related initiatives and, consequently, lowering military separations.

Primary Outcome Measures: Weight Loss, the amount of body weight loss in kilograms caused by semaglutide in 24 weeks., 24 weeks|Body composition, the percentage of lean and fat mass loss during semaglutide treatment., 24 weeks|Physical Performance, the percent change in VO2peak (mL/kg/min) during semaglutide treatment., 24 weeks
Secondary Outcome Measures: Weight Loss Maintenance, if semaglutide results in maintenance of lower body weight in kilograms 52 weeks after cessation of treatment., 76 weeks|Eating habits and mediators of eating behavior, the effects of semaglutide treatment on appetite, hunger, and food preferences measured by the military eating behavior scale during and after semaglutide treatment., 76 weeks
Other Outcome Measures: Bone, the effects of semaglutide treatment on bone volume/total volume during and after semaglutide treatment., 76 weeks