Comparison of Body Weight Change Through Different Smeglutide Administration Methods

Study Overview
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Brief Summary
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Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.

Detailed Description
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Participants will be randomized into either group. One group 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. The other group dosage regime depends on the tolerance of the semaglutide from participants. The dosage will stabilize on the dose how much participant could tolerate. At the end of 16 weeks treatment, comparison will be carried out on weight change before and after treatment and (1) Comparison of different administration methods (standards and titrations) on participant compliance, appetite and quality of life improvement; (2) Comparison of metabolism (waist hip circumference, body fat and body composition, blood pressure, blood lipid, blood glucose, insulin resistance) in different administration modes; (3) Comparison of adverse reactions of metabolic drugs in different administration modes.

Official Title
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Prospective Randomized Controlled Study on the Improvement of Body Weight Among Overweight and Obese Patients Through Different Smeglutide Administration Methods

Conditions
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Weight Change, Body

Intervention / Treatment
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* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 ≤ age<75; Overweight or obesity: meet either one of the following standards Patients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension, hyperlipidemia, apnea syndrome, cardiovascular disease) Simple obese patients with BMI ≥ 28kg/m2 Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for females Exclusion Criteria: Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia type 2 (MEN-2) patients. Patients with severe hypersensitivity to smeglutide or any other excipient component. 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). Triglyceride>5.6mmol/L; Participants in other clinical drug trials in recent three months. The range of weight change in recent 90 days is>5kg. Cushing's syndrome and abnormal thyroid function. Pregnant or breastfed women. The study doctor judged that it was not suitable to participate in the test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard arm<br>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.. | Drug: Semaglutide<br>* treatment with different dosage regimes<br>* Other names: dosage regime;|
| Active Comparator: titration arm<br>Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate | Drug: Semaglutide<br>* treatment with different dosage regimes<br>* Other names: dosage regime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change in kilograms | weight change in kilograms before and after treatment | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient compliance in rate | rate of participants dropout of the study（in percentage) | 16 weeks | 
| waist hip circumference in centimeter | waist hip circumference in centimeter | 16 weeks | 
| number of adverse events | number of adverse events including hypoglycemia, nausea, vomiting, abdominal pain, diarrhea, constipation, indigestion, burping, flatulence, injection site allergy. Adverse reactions will recorded in percentage (number of participants developed particular adverse reaction divided by all participants in each group, % ) | 16 weeks | 
| appetite change in score | appetite change measures in appetite questionnaire (visual analogue scales in assessment of appetite sensations, Units on scale is millimeter) | 16 weeks | 
| quality of life improvement in score | quality of life improvement (in WHOQOL BREF, Units on scale is point); | 16 weeks | 
| body fat in percentage | body fat in percentage | 16 weeks | 
| body composition of lean mass in kilogram | body composition in kilogram of lean mass | 16 weeks | 
| blood pressure in mmHg | blood pressure in mmHg | 16 weeks | 
| blood lipid in concentration | blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L), | 16 weeks | 
| fasting blood glucose level | fasting blood glucose in milli-mole per liter | 16 weeks | 
| HOMA-Beta value | the value of 20 × FINS/（FBG-3.5） | 16 weeks | 
| total cholesterol in mmol/L | total cholesterolin mmol/L | 16 weeks | 
| triglyceride | triglyceride in mmol/L | 16 weeks | 
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol in mmol/L | 16 weeks | 
| high-density lipoprotein cholesterol | high-density lipoprotein cholesterol in mmol/L | 16 weeks |