Comparison of Body Weight Change Through Different Smeglutide Administration Methods

Phase 4

Not yet recruiting

• Conditions: Weight Change, Body
• Interventions: Drug: Semaglutide

• Registration Number: NCT05616052
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-05
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-06
• Last Update Submitted: 2022-11-06
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15
• Study Start: 2022-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard arm	Semaglutide	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	Semaglutide	Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate

Primary Outcome Measures

Name	Time	Method
weight change in kilograms	16 weeks	weight change in kilograms before and after treatment

Secondary Outcome Measures

Name	Time	Method
waist hip circumference in centimeter	16 weeks	waist hip circumference in centimeter
fasting blood glucose level	16 weeks	fasting blood glucose in milli-mole per liter
HOMA-Beta value	16 weeks	the value of 20 × FINS/（FBG-3.5）
triglyceride	16 weeks	triglyceride in mmol/L
low-density lipoprotein cholesterol	16 weeks	low-density lipoprotein cholesterol in mmol/L
high-density lipoprotein cholesterol	16 weeks	high-density lipoprotein cholesterol in mmol/L
patient compliance in rate	16 weeks	rate of participants dropout of the study（in percentage)
number of adverse events	16 weeks	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, % )
body fat in percentage	16 weeks	body fat in percentage
total cholesterol in mmol/L	16 weeks	total cholesterolin mmol/L
appetite change in score	16 weeks	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	16 weeks	quality of life improvement (in WHOQOL\~BREF, Units on scale is point);
blood pressure in mmHg	16 weeks	blood pressure in mmHg
blood lipid in concentration	16 weeks	blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L),
body composition of lean mass in kilogram	16 weeks	body composition in kilogram of lean mass

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China