ObesityPhase 4NCT06468748
The Effects of Semaglutide on Body Composition and Performance in Military Personnel
A Phase 4 study testing Semaglutide in people with Obesity, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 27 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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).
- Claustrophobia or difficulty breathing with a face mask.
- Known or suspected hypersensitivity to study product(s) or related products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a GLP-1R Agonist (the Drug Wegovy®) on Body Composition and Performance in Military Personnel
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
- Being tested
- Semaglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
the amount of body weight loss in kilograms caused by semaglutide in 24 weeks.
Measured: 24 weeks
Body composition
the percentage of lean and fat mass loss during semaglutide treatment.
Measured: 24 weeks
Physical Performance
the percent change in VO2peak (mL/kg/min) during semaglutide treatment.
Measured: 24 weeks
Secondary outcomes (2)
Weight Loss Maintenance
if semaglutide results in maintenance of lower body weight in kilograms 52 weeks after cessation of treatment.
Measured: 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.
Measured: 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Aug 2024
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brandon Roberts, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468748
- Sponsor's protocol ID
- 24-05H
- Status last verified
- May 2025
- First submitted
- 5 Jun 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a GLP-1R Agonist (the Drug Wegovy®) on Body Composition and Performance in Military Personnel
- ClinicalTrials.gov ID
- NCT06468748
- Acronym / sponsor ID
- 24-05H
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Treatment | Experimental | Drug: SemaglutideSemaglutide 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideDuring 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) | Drug | Semaglutide Treatment |
Primary outcome
Weight Loss
Time frame: 24 weeks
the amount of body weight loss in kilograms caused by semaglutide in 24 weeks.
Body composition
Time frame: 24 weeks
the percentage of lean and fat mass loss during semaglutide treatment.
Physical Performance
Time frame: 24 weeks
the percent change in VO2peak (mL/kg/min) during semaglutide treatment.
2 secondary outcomes
Weight Loss Maintenance
Time frame: 76 weeks
Eating habits and mediators of eating behavior
Time frame: 76 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Obesity, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.