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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Weight Change, Body
• Intervention / Treatment: Drug: Semaglutide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: xiaolong zhao; Phone Number: 86-13501827230; Email: xiaolongzhao@163.com
• Study Contact Backup: Name: xiaolong zhao; Phone Number: 86-021-37990333

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Public Health Clinical Center
      • Contact: xiaolong zhao; Phone Number: 86-13501827230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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..	Drug: Semaglutide; treatment with different dosage regimes; Other Names: dosage regime
Active Comparator: 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	Drug: Semaglutide; treatment with different dosage regimes; Other Names: dosage regime

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Principal Investigator: xiaolong zhao, Shanghai Public Health Clinical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: 2022-10-weight loss-SPHCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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