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

NCT06468748 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 24-05H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Weight Loss Maintenance

  76 weeks

• Eating habits and mediators of eating behavior

  76 weeks

Other Outcomes (1)

• Bone

  76 weeks

Study Arms (1)

Semaglutide Treatment

EXPERIMENTAL

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.

Drug: Semaglutide

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)

Semaglutide Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active-duty military personnel
• Age ≥ 18 years at the time of signing informed consent.
• Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, etc.)
• History of at least one self-reported effort to lose body weight.
• Ability to exercise ≥ 3x per week during the study.

You may not qualify if:

• Currently in Basic Combat Training, Advanced Individual Training, or One Station Unit Training, or equivalence in other military services.
• Current or history of Type 1 or Type 2 Diabetes, cardiovascular (e.g., heart disease, peripheral artery disease), musculoskeletal (e.g., myopathies), immune (e.g., lupus, asthma), gastrointestinal (e.g., irritable bowel syndrome, pancreatitis), neurological (e.g., dystonia), pulmonary (pulmonary fibrosis, COPD, lung cancer), or renal diseases (e.g., kidney diseases), and eating disorders (e.g., bulimia nervosa, anorexia nervosa).
• History of cholecystectomy
• Personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia type 2.
• Participants who are pregnant or breastfeeding, or those who may be pregnant or were pregnant in the last 12 months.
• Male and female participants who plan or will attempt to become pregnant or help conceive a child within two months of treatment.
• Inability to exercise ≥ 3x per week during the study.
• Currently taking or history of routine use of medications known to affect metabolism or performance (e.g., thiazide diuretics, oral steroids, testosterone replacement therapy, etc.).
• Self-reported change in body weight ≥ 5 kg within 90 days before screening.
• Treatment with any medication for the indication of obesity within 90 days before screening.
• Treatment with other orally administered medications such as sulfonylureas, sitagliptin, phenytoin, levothyroxine, albuterol, prednisone, and other drugs as identified during screening by the medical screening and staff.
• Current or previously suspected alcohol abuse (defined as Harmful Use by the World Health Organization), those who meet criteria for alcohol abuse disorder (as outlined in the DSM-5), or other substance abuse (i.e., the use of illegal drugs or the use of prescription or over-the-counter drugs for purposes other than those for which they are meant to be used, or in excessive amounts.
• History of major depressive disorder.
• Participants with implanted or external electrical devices (e.g., pacemakers).
• On a specialized diet (e.g., keto, intermittent fasting).

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 21, 2024
• Study Start: August 1, 2024
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)