CompletedPhase NA

The Effect of Weekly Semaglutide Treatment on Energy Expenditure

Lead sponsor

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥25•Female

Primary endpoints

•Changes of Total Energy Expenditure•Changes of Energy Expenditure•Changes of Resting Energy Expenditure

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06390501

Org study IDSIAT-IRB-231215-H0705

Timeline

Milestones

Study start2024-04-01actual

Study first posted2024-04-30actual

Primary completion2025-08-15actual

Study completion2025-09-15actual

Last update posted2026-01-22actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

1. Age 18-60 years at time of enrollment

2. BMI ≥ 25 kg/m²

Exclusion criteria

1. Weight change exceeding 5 kilograms (11 pounds) in the past 90 days

2. Surgical treatment for past obesity, dieting, or undergoing weight loss treatment

3. Irregular diet and lifestyle, unhealthy habits such as smoking, alcohol, and drugs

4. Patients with metabolic diseases, basic diseases or infectious diseases

5. Patients with a personal or family history of medullary thyroid carcinoma (MTC), or patients with rare type 2 multiple endocrine tumor syndrome (MEN 2)

6. Current use of any other GLP1 receptor agonist

7. 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

Endpoints (58)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Weight & body composition

Cardiometabolic biomarkers

Other (unclassified)

Safety / tolerability / PK

Other clinical outcomes

Glycemic / diabetes

MASH / liver

Weight & body composition

10 endpoints

Secondary/protocol endpoint

Body Weight

Time frame:From baseline at week 0 to week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:From baseline at week 0 to week 24

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Waist and Hip circumferences

Time frame:From baseline at week 0 to week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Body shape

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Fat mass

Time frame:From baseline at week 0 to week 24

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Far free mass

Time frame:From baseline at week 0 to week 24

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Organ sizes

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Bone mass

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline at week 0 to week 24

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Body water

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in HbA1c

Time frame:From baseline at week 0 to week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Blood glucose

Time frame:From baseline at week 0 to week 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting serum insulin

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Change in fatty liver index (FLI) score category

Time frame:From baseline at week 0 to week 24

categorical status, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change in systolic and diastolic blood pressure

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change in lipids: Total cholesterol

Time frame:From baseline at week 0 to week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in lipids: High density lipoprotein (HDL) cholesterol

Time frame:From baseline at week 0 to week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in lipids: Low density lipoprotein (LDL) cholesterol

Time frame:From baseline at week 0 to week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

Time frame:From baseline at week 0 to week 24

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Free fatty acids (FFA)

Time frame:From baseline at week 0 to week 24

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Triglycerides

Time frame:From baseline at week 0 to week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

Time frame:From baseline at week 0 to week 24

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in pulse

Time frame:From baseline at week 0 to week 24

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Changes of Circulating Leptin Levels

Time frame:From baseline at week 0 to week 24

Leptin, change

change from baseline, improvement

Patient-reported / QoL

16 endpoints

Secondary/protocol endpoint

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

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - Hunger

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - Fullness

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - Satiety

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Mean postprandial rating - Prospective food consumption

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in physical functioning score

Time frame:From baseline at week 0 to week 24

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: role-physical score

Time frame:From baseline at week 0 to week 24

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: bodily pain score

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: general health score

Time frame:From baseline at week 0 to week 24

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: vitality score

Time frame:From baseline at week 0 to week 24

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: social functioning score

Time frame:From baseline at week 0 to week 24

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: role-emotional score

Time frame:From baseline at week 0 to week 24

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: mental health score

Time frame:From baseline at week 0 to week 24

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: physical component summary

Time frame:From baseline at week 0 to week 24

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: mental component summary

Time frame:From baseline at week 0 to week 24

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline at week 0 to week 24

SF-36 physical

threshold achievement, improvement

Safety / tolerability / PK

6 endpoints

Secondary/protocol endpoint

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

Time frame:From baseline at week 0 to week 24

Discontinuation due to AE

categorical status, event

Secondary/protocol endpoint

Time to permanent discontinuation of randomised trial product

Time frame:From baseline at week 0 to week 24

Discontinuation due to AE

time to event, event

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline at week 0 to week 24

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of serious adverse events (SAEs)

Time frame:From baseline at week 0 to week 24

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Change in amylase

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Secondary/protocol endpoint

Change in lipase

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Other clinical outcomes

4 endpoints

Primary/protocol endpoint/low confidence

Changes of Physical Activity

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in energy intake of test meal

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

componentsfat intake, total calorie intake

Secondary/protocol endpoint/low confidence

Energy intake during ad libitum lunch

Time frame:From baseline at week 0 to week 24

change from baseline, improvement

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

Changes of Total Energy Expenditure Assessed by Doubly Labeled Water Analysis

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Changes of Energy Expenditure Assessed by Chamber

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Changes of Resting Energy Expenditure

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Body temperature from surface temperature of the forehead

Time frame:From baseline at week 0 to week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Circulating hormones

Time frame:From baseline at week 0 to week 24

descriptive

Secondary/protocol endpoint/low confidence

Microbiome

Time frame:From baseline at week 0 to week 24

descriptive

Secondary/protocol endpoint/low confidence

Metabolites in serum, feces and urine

Time frame:From baseline at week 0 to week 24

descriptive

Secondary/protocol endpoint

Genetics

Time frame:From baseline at week 0 to week 24

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.