Caloric RestrictionNCT07874932
Long-Term Effects of Semaglutide on Body Composition and Performance in Running
A study testing Semaglutide (SEMA) in people with Caloric Restriction and Body Composition, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
Semaglutide, a GLP-1 receptor agonist, has demonstrated significant weight-loss effects in people with obesity and/or type 2 diabetes, but its impact on exercise performance among lean, fit athletes remains unknown. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caloric Restriction, Body Composition, Performance
- What is being tested?
- Semaglutide (SEMA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Oct 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy experienced triathletes or distance runners (training history +5 years and weekly training volume >10 h/week)
- Aged 18 to 45 years
- Body mass index (BMI) between 21.0-26.0 kg/m2
Who cannot join
- Chronic use of medication (except for occasional use of analgesics or antihistamines)
- Chronic disease (e.g. diabetes, disordered eating behavior (EDE-Q >2.5 for females and 1.7 for males))
- Abnormal kidney function, or ECG abnormalities.
- For female participants, additional exclusion criteria are
- Pregnancy
- Current or recent use of any hormonal contraceptives the last 6 months (including oral contraceptives, hormonal implants, injectable contraceptives, and hormone-releasing intrauterine devices)
- Irregular menstrual cycles (cycle length outside the 21-35-day range) and anovulatory cycles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
University of Copenhagen, August Krogh Section for Human and Molecular Physiology
Copenhagen, 2100
Morten Hostrup, PhD, MD, +45 24474785, hostrup@mortenhostrup.com
About this study
Official title: Mitigating Muscle Loss and Preserving Function During Incretin-induced Caloric Restriction
Semaglutide, a GLP-1 receptor agonist, has demonstrated significant weight-loss effects in people with obesity and/or type 2 diabetes, but its impact on exercise performance among lean, fit athletes remains unknown. This randomized placebo-controlled parallel intervention study aims to investigate the long-term effects of semaglutide on body composition, muscle mass, volume and function, running economy, and performance as well as on hormonal markers in well-trained male and female runners.
Read the detailed description
Healthy experienced triathletes or distance runners will complete a 12-week intervention with either weekly injections of semaglutide (titrated from 0.25 and up to 1.0 mg) or placebo. Furthermore, participants will complete a follow-up period consisting of 4 weeks without treatment. Before and after the intervention period as well as the follow-up period, participants will complete 2 experimental days (6 experimental days in total). On experimental days, change in body composition, with a particular focus on muscle mass, will be assessed using DXA scans and ultrasound imaging of v. lateralis. In addition, specific performance tests (200-m, 3-km, 10-km) and running economy, as well as hormonal markers in serum and urine will be measured.
- Conditions
- Caloric Restriction, Body Composition, Performance
- Being tested
- Semaglutide (SEMA), Placebo
- Keywords
- semaglutide, muscle, steroidal module markers, endocrine module markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (SEMA)Drug
The semaglutide group will receive subcutaneous injections with semaglutide, titrated from 0.25 mg up to 1.0 mg once weekly in accordance with standard treatment guidelines (dose increasing every 4 week). After the 12-week intervention period, participants will complete a 4 week follow-up period without treatment.
PlaceboDrug
The placebo group will receive subcutaneous injections with placebo once weekly. After the 12-week intervention period, participants will complete a 4 week follow-up period without treatment.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive semaglutide treatment for 12 weeks. This will be followed by a 4-week follow-up period without treatment. Receives: Drug: Semaglutide (SEMA) |
| Placebo | Placebo comparator | Participants will receive placebo treatment for 12 weeks. This will be followed by a 4-week follow-up period without treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total lean mass measured by dual-energy X-ray absorptiometry (DXA)
Total lean mass will be assessed using dual-energy X-ray absorptiometry (DXA). The change in total lean mass from baseline to the end of the 4-week intervention period will be calculated (unit of measure: kilograms (kg)).
Measured: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Secondary outcomes (4)
Change in muscle thickness measured by ultrasonography
Muscle thickness will be assessed by ultrasonography at predefined anatomical sites. The change in muscle thickness from baseline to the end of the 4-week intervention period will be calculated (unit of measure: millimeters (mm)).
Measured: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Change in running performance
Running performance will be assessed using 200-m, 3-km and 10-km running performance as well as running economy and VO2max during an incremental test on treadmill.
Measured: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Change in maximal voluntary isometric quadriceps contraction torque
Maximal voluntary isometric contraction torque of the quadriceps muscles will be assessed using an isometric strength test. The change in maximal isometric contraction torque from baseline to the end of the 4-week intervention period will be calculated (unit of measure: newton-meters (N*m)).
Measured: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Change in one-repetition maximum (1RM) leg press strength
Lower-body muscle strength will be assessed using a one-repetition maximum (1RM) leg press test. The change in 1RM leg press strength from baseline to the end of the 4-week intervention period will be calculated (unit of measure: kilograms (kg)).
Measured: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caloric RestrictionStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874932
- Sponsor's protocol ID
- GLP-1_long
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Muscle Loss and Preserving Function During Incretin-induced Caloric Restriction
- ClinicalTrials.gov ID
- NCT07874932
- Acronym / sponsor ID
- GLP-1_long
- Conditions
- Caloric Restriction, Body Composition, Performance
- Keywords
- semaglutide, muscle, steroidal module markers, endocrine module markers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Oct 2026 (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.
Semaglutide, a GLP-1 receptor agonist, has demonstrated significant weight-loss effects in people with obesity and/or type 2 diabetes, but its impact on exercise performance among lean, fit athletes remains unknown. This randomized placebo-controlled parallel intervention study aims to investigate the long-term effects of semaglutide on body composition, muscle mass, volume and function, running economy, and performance as well as on hormonal markers in well-trained male and female runners.
Detailed description
Healthy experienced triathletes or distance runners will complete a 12-week intervention with either weekly injections of semaglutide (titrated from 0.25 and up to 1.0 mg) or placebo. Furthermore, participants will complete a follow-up period consisting of 4 weeks without treatment. Before and after the intervention period as well as the follow-up period, participants will complete 2 experimental days (6 experimental days in total). On experimental days, change in body composition, with a particular focus on muscle mass, will be assessed using DXA scans and ultrasound imaging of v. lateralis. In addition, specific performance tests (200-m, 3-km, 10-km) and running economy, as well as hormonal markers in serum and urine will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide (SEMA)Participants will receive semaglutide treatment for 12 weeks. This will be followed by a 4-week follow-up period without treatment. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo treatment for 12 weeks. This will be followed by a 4-week follow-up period without treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy experienced triathletes or distance runners (training history +5 years and weekly training volume >10 h/week)
- Aged 18 to 45 years
- Body mass index (BMI) between 21.0-26.0 kg/m2
Key exclusion criteria (7 listed)
- Chronic use of medication (except for occasional use of analgesics or antihistamines)
- Chronic disease (e.g. diabetes, disordered eating behavior (EDE-Q >2.5 for females and 1.7 for males))
- Abnormal kidney function, or ECG abnormalities.
- For female participants, additional exclusion criteria are
- Pregnancy
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 |
|---|---|---|
| Semaglutide (SEMA)The semaglutide group will receive subcutaneous injections with semaglutide, titrated from 0.25 mg up to 1.0 mg once weekly in accordance with standard treatment guidelines (dose increasing every 4 week). After the 12-week intervention period, participants will complete a 4 week follow-up period without treatment. | Drug | Semaglutide |
| PlaceboThe placebo group will receive subcutaneous injections with placebo once weekly. After the 12-week intervention period, participants will complete a 4 week follow-up period without treatment. | Drug | Placebo |
Primary outcome
Change in total lean mass measured by dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Total lean mass will be assessed using dual-energy X-ray absorptiometry (DXA). The change in total lean mass from baseline to the end of the 4-week intervention period will be calculated (unit of measure: kilograms (kg)).
4 secondary outcomes
Change in muscle thickness measured by ultrasonography
Time frame: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Change in running performance
Time frame: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Change in maximal voluntary isometric quadriceps contraction torque
Time frame: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Change in one-repetition maximum (1RM) leg press strength
Time frame: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semaglutide (SEMA) in people with Caloric Restriction and Body Composition, run by Morten Hostrup, PhD at 1 site in Denmark.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 Oct 2026. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten Hostrup, PhD, MD (+45 24474785, hostrup@mortenhostrup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total lean mass measured by dual-energy X-ray absorptiometry (DXA) (time frame: Baseline (week 0), immediately after the 12-week intervention period (week 12), and immediately after the 4-week follow-up period without treatment (week 16).). 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 15 Oct 2026.