Comparison of Body Weight Change Through Different Smeglutide Administration Methods
NCT ID: NCT05616052
Last Updated: 2022-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2022-12-01
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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standard arm
standard arm will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks..
Semaglutide
treatment with different dosage regimes
titration arm
Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate
Semaglutide
treatment with different dosage regimes
Interventions
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Semaglutide
treatment with different dosage regimes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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xiaolong zhao
Professor of endocrinology department
Principal Investigators
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xiaolong zhao
Role: PRINCIPAL_INVESTIGATOR
Shanghai Public Health Clinical Center
Locations
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Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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xiaolong zhao
Role: CONTACT
Facility Contacts
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xiaolong zhao
Role: primary
References
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Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4.
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
Blundell J, Finlayson G, Axelsen M, Flint A, Gibbons C, Kvist T, Hjerpsted JB. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab. 2017 Sep;19(9):1242-1251. doi: 10.1111/dom.12932. Epub 2017 May 5.
Other Identifiers
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2022-10-weight loss-SPHCC
Identifier Type: -
Identifier Source: org_study_id
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