The Effect of Weekly Semaglutide Treatment on Energy Expenditure

NCT06390501 | Completed

• 1 other identifier: SIAT-IRB-231215-H0705
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Drug

Outcome Measures

Primary Outcomes (4)

• 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.

  From baseline at week 0 to week 24

• Changes of Energy Expenditure Assessed by Chamber

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

  From baseline at week 0 to week 24

• 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.

  From baseline at week 0 to week 24

• 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.

  From baseline at week 0 to week 24

Secondary Outcomes (54)

• Body Weight

  From baseline at week 0 to week 24

• Body Mass Index (BMI)

  From baseline at week 0 to week 24

• Waist and Hip circumferences

  From baseline at week 0 to week 24

• Body shape

  From baseline at week 0 to week 24

• Fat mass

  From baseline at week 0 to week 24

Study Arms (2)

Semaglutide

EXPERIMENTAL

Once-weekly injections of gradually increased doses of semaglutide

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Once-weekly injections of gradually increased volumes of saline placebo, to match the volumes of the semaglutide treated arm.

Drug: Placebo

Interventions

Semaglutide DRUG

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

Semaglutide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• \) Subject unlikely to adhere to study procedures in opinion of investigator

Sponsors & Collaborators

• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: lead

Study Sites (1)

Shenzhen Institute of Advanced Technology

Shenzhen, China

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John R Speakman

  Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Scientist

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CN (1)