Back to resultsComparison of Body Weight Change Through Different Smeglutide Administration Methods
Primary Purpose
Weight Change, Body
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Semaglutide
Sponsored by
About this trial
This is an interventional treatment trial for Weight Change, Body
Eligibility Criteria
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.
Sites / Locations
- Shanghai Public Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
standard arm
titration arm
Arm Description
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..
Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate
Outcomes
Primary Outcome Measures
weight change in kilograms
weight change in kilograms before and after treatment
Secondary Outcome Measures
patient compliance in rate
rate of participants dropout of the study（in percentage)
waist hip circumference in centimeter
waist hip circumference in centimeter
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, % )
appetite change in score
appetite change measures in appetite questionnaire (visual analogue scales in assessment of appetite sensations, Units on scale is millimeter)
quality of life improvement in score
quality of life improvement (in WHOQOL~BREF, Units on scale is point);
body fat in percentage
body fat in percentage
body composition of lean mass in kilogram
body composition in kilogram of lean mass
blood pressure in mmHg
blood pressure in mmHg
blood lipid in concentration
blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L),
fasting blood glucose level
fasting blood glucose in milli-mole per liter
HOMA-Beta value
the value of 20 × FINS/（FBG-3.5）
total cholesterol in mmol/L
total cholesterolin mmol/L
triglyceride
triglyceride in mmol/L
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol in mmol/L
high-density lipoprotein cholesterol
high-density lipoprotein cholesterol in mmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05616052
Brief Title
Comparison of Body Weight Change Through Different Smeglutide Administration Methods
Official Title
Prospective Randomized Controlled Study on the Improvement of Body Weight Among Overweight and Obese Patients Through Different Smeglutide Administration Methods
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Change, Body
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard arm
Arm Type
Active Comparator
Arm Description
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..
Arm Title
titration arm
Arm Type
Active Comparator
Arm Description
Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
dosage regime
Intervention Description
treatment with different dosage regimes
Primary Outcome Measure Information:
Title
weight change in kilograms
Description
weight change in kilograms before and after treatment
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
patient compliance in rate
Description
rate of participants dropout of the study（in percentage)
Time Frame
16 weeks
Title
waist hip circumference in centimeter
Description
waist hip circumference in centimeter
Time Frame
16 weeks
Title
number of adverse events
Description
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, % )
Time Frame
16 weeks
Title
appetite change in score
Description
appetite change measures in appetite questionnaire (visual analogue scales in assessment of appetite sensations, Units on scale is millimeter)
Time Frame
16 weeks
Title
quality of life improvement in score
Description
quality of life improvement (in WHOQOL~BREF, Units on scale is point);
Time Frame
16 weeks
Title
body fat in percentage
Description
body fat in percentage
Time Frame
16 weeks
Title
body composition of lean mass in kilogram
Description
body composition in kilogram of lean mass
Time Frame
16 weeks
Title
blood pressure in mmHg
Description
blood pressure in mmHg
Time Frame
16 weeks
Title
blood lipid in concentration
Description
blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L),
Time Frame
16 weeks
Title
fasting blood glucose level
Description
fasting blood glucose in milli-mole per liter
Time Frame
16 weeks
Title
HOMA-Beta value
Description
the value of 20 × FINS/（FBG-3.5）
Time Frame
16 weeks
Title
total cholesterol in mmol/L
Description
total cholesterolin mmol/L
Time Frame
16 weeks
Title
triglyceride
Description
triglyceride in mmol/L
Time Frame
16 weeks
Title
low-density lipoprotein cholesterol
Description
low-density lipoprotein cholesterol in mmol/L
Time Frame
16 weeks
Title
high-density lipoprotein cholesterol
Description
high-density lipoprotein cholesterol in mmol/L
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaolong zhao
Phone
86-13501827230
Email
xiaolongzhao@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiaolong zhao
Phone
86-021-37990333
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaolong zhao
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaolong zhao
Phone
86-13501827230
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34097869
Citation
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.
Results Reference
background
PubMed Identifier
10702749
Citation
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.
Results Reference
background
PubMed Identifier
28266779
Citation
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.
Results Reference
background
Learn more about this trial
Comparison of Body Weight Change Through Different Smeglutide Administration Methods
We'll reach out to this number within 24 hrs