The Effect of Weekly Semaglutide Treatment on Energy Expenditure
- Sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Study ID
- NCT06390501
- Status
- Completed
Conditions
- Obesity; Drug
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Semaglutide — DRUGSolution for subcutaneous (s.c. - under the skin) injection. 0.25 mg semaglutide once weekly for four weeks, 0.5 mg semaglutide once weekly for four weeks, 0.1 mg semaglutide once weekly for four weeks, 1.7 mg semaglutide once weekly for four weeks followed by 2.4 mg semaglutide once weekly for eight weeks
- Placebo — DRUGSolution for subcutaneous (s.c. - under the skin) injection
Study Details
This study will test the effects of weekly injections of the glucagon like peptide-1 (GLP-1) agonist semaglutide on energy expenditure and metabolic parameters in a 24 week double-blind, placebo-controlled dose escalation randomized trial. After baseline testing, 52 patients will be randomly assigned to the semaglutide or matching placebo injection group. In addition to taking medication or placebo, all participants will a calorie restricted diet provided by the researchers, providing 600 kcals per day below their estimated baseline requirements. Before and at the end of treatment, weight status, body composition, basal metabolic rate (BEE), 24h energy expenditure, daily total energy expenditure (TEE) for free living, physical activity, energy intake (questionnaire and food table), and hormone parameters for energy homeostasis will be evaluated.
Key Dates
- Start date
- Apr 1, 2024
- Status verified
- Jan 2026
- Primary completion
- Aug 15, 2025
- Completion
- Sep 15, 2025
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: SemaglutideOnce-weekly injections of gradually increased doses of semaglutide
- Placebo Comparator: PlaceboOnce-weekly injections of gradually increased volumes of saline placebo, to match the volumes of the semaglutide treated arm.
Primary Outcome Measure
Changes of Total Energy Expenditure Assessed by Doubly Labeled Water Analysis [ Time Frame: From baseline at week 0 to week 24 ]