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Obesity; DrugNCT06390501

The Effect of Weekly Semaglutide Treatment on Energy Expenditure

A study testing Semaglutide in people with Obesity; Drug, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity; Drug
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
1 Apr 2024to 15 Sep 2025
Phase
Interventional
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 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-60 years at time of enrollment
  • BMI ≥ 25 kg/m²

Who cannot join

  • Weight change exceeding 5 kilograms (11 pounds) in the past 90 days
  • Surgical treatment for past obesity, dieting, or undergoing weight loss treatment
  • Irregular diet and lifestyle, unhealthy habits such as smoking, alcohol, and drugs
  • Patients with metabolic diseases, basic diseases or infectious diseases
  • Patients with a personal or family history of medullary thyroid carcinoma (MTC), or patients with rare type 2 multiple endocrine tumor syndrome (MEN 2)
  • Current use of any other GLP1 receptor agonist
  • Pregnancy, lactation or expectation to conceive during study period (8) Subject with contraindication to neuroimaging by MRI (9) People with fear of blood and pathologically low blood pressure (10) Use of antibiotics and probiotics within 8 weeks
  • 11) Subject unlikely to adhere to study procedures in opinion of investigator

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenzhen Institute of Advanced Technology

    Shenzhen

Other trials in China

About this study

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.

Read the detailed description

Obesity is a complex chronic recurrent multifactorial disease characterized by abnormal or excessive body fat, which impairs physical health. In recent years, the glucagon like peptide-1 (GLP-1) receptor agonist semaglutide has attracted much attention due to its significant impact on weight loss. It can not only effectively control blood sugar by regulating the secretion of insulin and glucagon. It can also participate in certain brain regions of the body at pharmacological doses, regulating food intake and consumption. Semaglutide reduces energy intake and achieves weight loss by delaying gastric emptying, suppressing appetite, reducing hunger, and increasing satiety. This effect has been proven to be produced by activating the glucagon like peptide-1 (GLP-1) receptors in the central nervous system, further indirectly regulating the activity of neurons involved in appetite regulation, food intake, and preference.

The previous results of using GLP-1 receptor agonist (RA) in rats and humans provide promising evidence data to support current randomized clinical trials. Peripheral administration of GLP-1 or GLP-1 RA can reduce blood sugar and energy intake in humans and rodents, and long-term treatment can lead to weight loss. In mice the drug also sustains energy expenditure at levels similar to controls, preventing the reduction that normally accompanies caloric restriction. Whether the same effects occur in humans is unclear because no studies have yet been performed comparing semaglutide treated individuals with those on a standard calorie restricted diet (in effect pair feeding). Therefore, in this study, researchers will use doubly- labelled water (DLW) and respiratory chambers to investigate whether semaglutide can prevent the reduction of energy expenditure that typically occurs during energy restriction.

Conditions
Obesity; Drug
Being tested
Semaglutide, Placebo
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Solution 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

  • PlaceboDrug

    Solution for subcutaneous (s.c. - under the skin) injection

Study groups in NCT06390501
Study groupRoleWhat they receive
SemaglutideExperimentalOnce-weekly injections of gradually increased doses of semaglutide
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorOnce-weekly injections of gradually increased volumes of saline placebo, to match the volumes of the semaglutide treated arm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of Total Energy Expenditure Assessed by Doubly Labeled Water Analysis

    TEE will be measured using the DLW method. Urine samples from all participants in the DLW subset will be stored at -20 ℃ and shipped on dry ice for analysis in the laboratory of Dr. John Speakman at the Shenzhen Institute of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation (Speakman et al 2021: Cell reports medicine). TEE will then be calculated using mean CO2 production using the Weir equation.

    Measured: From baseline at week 0 to week 24

  2. Changes of Energy Expenditure Assessed by Chamber

    The total energy expenditure in a free living environment is measured using a 24-hour chamber.

    Measured: From baseline at week 0 to week 24

  3. Changes of Resting Energy Expenditure

    Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and CO2 production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.

    Measured: From baseline at week 0 to week 24

  4. Changes of Physical Activity

    Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days.

    Measured: From baseline at week 0 to week 24

Secondary outcomes (54)

  1. Body Weight

    Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes.

    Measured: From baseline at week 0 to week 24

  2. Body Mass Index (BMI)

    Percent change of body mass index (BMI), as calculated by the formula: body weight in kg divided by height in meters², between baseline and the end of the 24-week randomized drug treatment phase.

    Measured: From baseline at week 0 to week 24

  3. Waist and Hip circumferences

    Waist and Hip circumferences will be measured using a whole body laser scanner.

    Measured: From baseline at week 0 to week 24

  4. Body shape

    Body shape will be measured using a whole body laser scanner.

    Measured: From baseline at week 0 to week 24

  5. Fat mass

    Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).

    Measured: From baseline at week 0 to week 24

  6. Far free mass

    Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).

    Measured: From baseline at week 0 to week 24

  7. Organ sizes

    Volumes of the brain, liver, spleen, pancreas, kidneys, subcutaneous and visceral adipose tissue, skeletal muscle in the limbs, trunk and shoulders will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).

    Measured: From baseline at week 0 to week 24

  8. Bone mass

    Bone mass will be measured by Dual Energy X-ray Absorptiometry (DEXA) (Hologic)

    Measured: From baseline at week 0 to week 24

  9. Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA)

    Body composition change between baseline and the end of the 24-week randomized drug treatment phase assessed by dual energy x-ray absorptiometry (DEXA) and expressed as the change in fat mass.

    Measured: From baseline at week 0 to week 24

  10. Change in energy intake of test meal

    The food intake will be assessed objectively by use of a feeding table. The test meal will be provided as lunch, and food types available on the table include staples, vegetables, mushrooms, meat, soy products, desserts, beverages and water. All types of food are unlimited. Food consumption will be recorded continuously by balances concealed under each food dish. The food energy density for each food will be measured by bomb calorimetry in kJ/g, and energy intake will be calculated as the product of the grams of each food eaten multiplied by the respective energy density and then summed, as kJ.

    Measured: From baseline at week 0 to week 24

  11. Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis

    Changes in fat and total calorie intake during free buffet meals assessed at baseline and after 24-weeks of study drug treatment.

    Measured: From baseline at week 0 to week 24

  12. Energy intake during ad libitum lunch

    The food intake will be assessed objectively by use of a feeding table. The test meal will be provided as lunch, and food types available on the table include staples, vegetables, mushrooms, meat, soy products, desserts, beverages and water. All types of food are unlimited. Food consumption will be recorded continuously by balances concealed under each food dish. The food energy density for each food will be measured by bomb calorimetry in kJ/g, and energy intake will be calculated as the product of the grams of each food eaten multiplied by the respective energy density and then summed, as kJ.

    Measured: From baseline at week 0 to week 24

  13. Body temperature from surface temperature of the forehead

    Body temperature will be measured before and after feeding using a thermal imaging camera. The camera is directed at the forehead to measure the surface temperature.

    Measured: From baseline at week 0 to week 24

  14. Body water

    Body water will be measured by deuterium dilution. Subjects will attend in the lab after an overnight fast and provide a baseline urine sample. They will then drink a dose of deuterated water based on their body weight. Three and four hours after dosing a urine sample will be collected to measure the level of deuterium isotope in the body relative to the baseline. This increase allows measurement of the amount of water in the body that diluted the dose.

    Measured: From baseline at week 0 to week 24

  15. Overall appetite score (OAS) before and after intake of a standardised meal

    give a score from 0 to 100

    Measured: From baseline at week 0 to week 24

  16. Mean postprandial rating - Hunger

    give a score from 0 to 100, The ends of each line indicate the most extreme sensation respondents have experienced

    Measured: From baseline at week 0 to week 24

  17. Mean postprandial rating - Fullness

    give a score from 0 to 100, The ends of each line indicate the most extreme sensation respondents have experienced

    Measured: From baseline at week 0 to week 24

  18. Mean postprandial rating - Satiety

    give a score from 0 to 100, The ends of each line indicate the most extreme sensation respondents have experienced

    Measured: From baseline at week 0 to week 24

  19. Mean postprandial rating - Prospective food consumption

    give a score from 0 to 100, The ends of each line indicate the most extreme sensation respondents have experienced

    Measured: From baseline at week 0 to week 24

  20. Change in physical functioning score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  21. Change in SF-36: role-physical score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  22. Change in SF-36: bodily pain score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  23. Change in SF-36: general health score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  24. Change in SF-36: vitality score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  25. Change in SF-36: social functioning score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  26. Change in SF-36: role-emotional score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  27. Change in SF-36: mental health score

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  28. Change in SF-36: physical component summary

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  29. Change in SF-36: mental component summary

    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.

    Measured: From baseline at week 0 to week 24

  30. Subjects who achieve responder definition value for SF-36 physical functioning score (yes/no)

    Number of subjects

    Measured: From baseline at week 0 to week 24

  31. Change in HbA1c

    mmol /mol

    Measured: From baseline at week 0 to week 24

  32. Change in systolic and diastolic blood pressure

    Systolic and diastolic blood pressure will be measured using an Omron digital sphygmomanometer, as mmHg.

    Measured: From baseline at week 0 to week 24

  33. Blood glucose

    Fasting and post-prandial glucose after a standard meal will be recorded by a continuous glucose monitoring system.

    Measured: From baseline at week 0 to week 24

  34. Change in fasting serum insulin

    mIU/L

    Measured: From baseline at week 0 to week 24

  35. Change in lipids: Total cholesterol

    mg/dL

    Measured: From baseline at week 0 to week 24

  36. Change in lipids: High density lipoprotein (HDL) cholesterol

    mg/dL

    Measured: From baseline at week 0 to week 24

  37. Change in lipids: Low density lipoprotein (LDL) cholesterol

    mg/dL

    Measured: From baseline at week 0 to week 24

  38. Change in lipids: Very low density lipoprotein (VLDL) cholesterol

    mg/dL

    Measured: From baseline at week 0 to week 24

  39. Change in lipids: Free fatty acids (FFA)

    mg/dL

    Measured: From baseline at week 0 to week 24

  40. Change in lipids: Triglycerides

    mg/dL

    Measured: From baseline at week 0 to week 24

  41. Change in fatty liver index (FLI) score category

    Below 30, equal to or above 30 and below 60, equal to or above 60

    Measured: From baseline at week 0 to week 24

  42. Changes in Inflammation Assessed by C-reactive Protein (CRP)

    Change in C-reactive protein (CRP) between baseline and the end of the 24-week randomized drug treatment phase

    Measured: From baseline at week 0 to week 24

  43. Subjects who have permanently discontinued randomised trial product (yes/no)

    Number of subjects

    Measured: From baseline at week 0 to week 24

  44. Time to permanent discontinuation of randomised trial product

    Weeks

    Measured: From baseline at week 0 to week 24

  45. Number of treatment emergent adverse events (TEAEs)

    Count

    Measured: From baseline at week 0 to week 24

  46. Number of serious adverse events (SAEs)

    Count

    Measured: From baseline at week 0 to week 24

  47. Change in pulse

    Beats per minute (bpm)

    Measured: From baseline at week 0 to week 24

  48. Change in amylase

    U/L

    Measured: From baseline at week 0 to week 24

  49. Change in lipase

    U/L

    Measured: From baseline at week 0 to week 24

  50. Changes of Circulating Leptin Levels

    Change in circulating leptin between baseline and the end of the 24-week randomized drug treatment phase

    Measured: From baseline at week 0 to week 24

  51. Circulating hormones

    Nurses will collect the blood samples every month. Levels of circulating hormones (including leptin, insulin, ghrelin etc) and metabolic fuels (glycogen, lactate glucose etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L.

    Measured: From baseline at week 0 to week 24

  52. Microbiome

    Abundance of gut microbiome will be from Metagenomic profiling of feces by Illumina.

    Measured: From baseline at week 0 to week 24

  53. Metabolites in serum, feces and urine

    Abundance of metabolites will be from metabolomic profiling of serum, urine and feces by LC-MS (liquid chromatography-mass spectrometry).

    Measured: From baseline at week 0 to week 24

  54. Genetics

    Polymorphic variation will be assessed in a panel of SNPs (single nucleotide polymorphism) previously linked to body composition and physical activity using a Mass array sequencer.

    OR The subjects will have their venous blood collected in a fasted state. 4ml of venous blood (BD vacutainer K2 EDTA, BD, USA) will be used to extract genomic DNA (TIANamp Blood DNA kit, TIANGEN, China. QIAamp Midi Blood DNA kit, QIAGEN, Germany) for Single nucleotide polymorphism (SNP) genotyping (Agena MassARRAY, CapitalBio Technology, China).

    Measured: From baseline at week 0 to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion15 Aug 2025
  4. Study completion15 Sep 2025

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390501
Sponsor's protocol ID
SIAT-IRB-231215-H0705
Status last verified
Jan 2026
First submitted
11 Apr 2024
Last updated
22 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Semaglutide in people with Obesity; Drug, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.

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 2 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jan 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes of Total Energy Expenditure Assessed by Doubly Labeled Water Analysis (time frame: From baseline at week 0 to week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390501.

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 22 Jan 2026.

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