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Comparison of Body Weight Change Through Different Smeglutide Administration Methods
Prospective Randomized Controlled Study on the Improvement of Body Weight Among Overweight and Obese Patients Through Different Smeglutide Administration Methods
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
80
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥24
Primary endpoint
•Body weight, absolute change (kg)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 18 ≤ age<75;
2. Overweight or obesity: meet either one of the following standards
1. Patients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension, hyperlipidemia, apnea syndrome, cardiovascular disease)
2. Simple obese patients with BMI ≥ 28kg/m2
3. Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for females
Exclusion criteria
1. Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia type 2 (MEN-2) patients.
2. Patients with severe hypersensitivity to smeglutide or any other excipient component.
3. Diabetic patients (glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L or blood glucose ≥ 11.1 mmol/L 2 hours after meal or random blood glucose ≥ 11.1 mmol/L).
4. Triglyceride>5.6mmol/L;
5. Participants in other clinical drug trials in recent three months.
6. The range of weight change in recent 90 days is>5kg.
7. Cushing's syndrome and abnormal thyroid function.
8. Pregnant or breastfed women.
9. The study doctor judged that it was not suitable to participate in the test.
Endpoints (16)
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
Weight & body composition
4 endpointsweight change in kilograms
Time frame:16 weeks
Body weight, absolute change (kg)
change from baseline, improvement
waist hip circumference in centimeter
Time frame:16 weeks
descriptive, improvement
body fat in percentage
Time frame:16 weeks
Total fat mass
descriptive, improvement
body composition of lean mass in kilogram
Time frame:16 weeks
Lean mass
change from baseline, improvement
Glycemic / diabetes
2 endpointsfasting blood glucose level
Time frame:16 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
HOMA-Beta value
Time frame:16 weeks
descriptive, improvement
Cardiometabolic biomarkers
6 endpointsblood pressure in mmHg
Time frame:16 weeks
descriptive, improvement
blood lipid in concentration
Time frame:16 weeks
descriptive, improvement
total cholesterol in mmol/L
Time frame:16 weeks
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
triglyceride
Time frame:16 weeks
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
low-density lipoprotein cholesterol
Time frame:16 weeks
LDL-C, change
change from baseline, improvement
LOINC 13457-7
high-density lipoprotein cholesterol
Time frame:16 weeks
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Patient-reported / QoL
2 endpointsappetite change in score
Time frame:16 weeks
change from baseline, improvement
quality of life improvement in score
Time frame:16 weeks
change from baseline, improvement
Safety / tolerability / PK
2 endpointspatient compliance in rate
Time frame:16 weeks
descriptive
number of adverse events
Time frame:16 weeks
Treatment-emergent AEs (any)
event count, event
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The lancet. Diabetes & endocrinology2021 Jul (month)PMID34097869doi:10.1016/S2213-8587(21)00118-2via CT.gov background
- Diabetes, obesity & metabolism2017 Sep (month)PMID28266779doi:10.1111/dom.12932via CT.gov background
- International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity2000 Jan (month)PMID10702749doi:10.1038/sj.ijo.0801083via CT.gov background
Provenance
Sources
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 1, 2026 snapshot.