Short Term Effects of Semaglutide on Body Composition and Performance

NCT07874971 | Not Yet Recruiting

• 1 other identifier: GLP-1_short
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. This randomized placebo-controlled parallel intervention study aims to investigate the short-term effects of semaglutide on body composition, muscle mass, volume and function, running economy, and performance in well-trained male and female runners.

Conditions

Caloric Restriction; Body Composition; Performance

Keywords

semaglutide; muscle

Outcome Measures

Primary Outcomes (1)

• 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)).

  Baseline (week 0) and immediately after the 4-week intervention period (week 4)

Secondary Outcomes (4)

• Change in muscle thickness measured by ultrasonography

  Baseline (week 0) and immediately after the 4-week intervention period (week 4)

• Change in running performance

  Baseline (week 0) and immediately after the 4-week intervention period (week 4)

• Change in maximal voluntary isometric quadriceps contraction torque

  Baseline (week 0) and immediately after the 4-week intervention period (week 4)

• Change in one-repetition maximum (1RM) leg press strength

  Baseline (Week 0) and immediately after the 4-week intervention period (Week 4).

Study Arms (2)

Semaglutide

EXPERIMENTAL

Participants will receive semaglutide treatment for 4 weeks

Drug: Semaglutide (SEMA)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo treatment for 4 weeks

Drug: Placebo

Interventions

Semaglutide (SEMA) DRUG

Participants will receive a 4-week semaglutide treatment with subcutaneous injections of 0.25 mg once weekly.

Semaglutide

Placebo DRUG

Participants will receive a 4-week placebo treatment with subcutaneous injections once weekly.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Morten Hostrup, PhD: lead

Study Sites (1)

University of Copenhagen, August Krogh Section for Human and Molecular Physiology

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

semaglutide

Central Study Contacts

Morten Hostrup, PhD, MD

CONTACT

+45 24474785; hostrup@mortenhostrup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher, Professor, MD

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 15, 2026
• Study Start: October 14, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)