The Effects of Semaglutide on Body Composition and Performance in Military Personnel

Part of paid clinical trials in Natick, Massachusetts.

Sponsor
United States Army Research Institute of Environmental Medicine
Study ID
NCT06468748
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    During the first visit, participants will be taught how to self-administer the pen injector by medical staff. Participants will also be provided instructions for self-administering injections and a compliance log to track adherence to the treatment, and additional information about each injection (date, time, injection site)

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
May 2025
Primary completion
Mar 27, 2025
Completion
Mar 27, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Treatment
    Semaglutide will be self-administered by participants with a prefilled pen injector on the same day each week, at any time of day, with or without meals. It will be initiated at a dose of 0.25 mg once weekly for the first 4 weeks, with the dose increased every 4 weeks to reach a maintenance dose of 2.4 mg weekly by week 16. They will remain on the maintenance dosage of 2.4mg until week 24. If participants cannot reach 2.4 mg/week they will stop at the maximal tolerable dose (e.g., 1.7 mg/week). After 24-weeks, treatment will be stopped, and participants will remain in the trial for 1 year with follow-up assessments at week 48 and week 76.

Primary Outcome Measure

Weight Loss [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
USARIEMNatickMassachusetts01760-

Find similar trials in Natick, MA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
USARIEM· Natick, MA

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