Comparison of Body Weight Change Through Different Smeglutide Administration Methods

Weight Change, Body Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616052
• Other study ID #: 2022-10-weight loss-SPHCC
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2022
• Source: Huashan Hospital
• Contact: xiaolong zhao
• Phone: 86-13501827230
• Email: xiaolongzhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Weight Change, Body

Intervention

Drug:
• Semaglutide
treatment with different dosage regimes

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change in kilograms	weight change in kilograms before and after treatment	16 weeks
Secondary	patient compliance in rate	rate of participants dropout of the study(in percentage)	16 weeks
Secondary	waist hip circumference in centimeter	waist hip circumference in centimeter	16 weeks
Secondary	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
Secondary	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
Secondary	quality of life improvement in score	quality of life improvement (in WHOQOL~BREF, Units on scale is point);	16 weeks
Secondary	body fat in percentage	body fat in percentage	16 weeks
Secondary	body composition of lean mass in kilogram	body composition in kilogram of lean mass	16 weeks
Secondary	blood pressure in mmHg	blood pressure in mmHg	16 weeks
Secondary	blood lipid in concentration	blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L),	16 weeks
Secondary	fasting blood glucose level	fasting blood glucose in milli-mole per liter	16 weeks
Secondary	HOMA-Beta value	the value of 20 × FINS/(FBG-3.5)	16 weeks
Secondary	total cholesterol in mmol/L	total cholesterolin mmol/L	16 weeks
Secondary	triglyceride	triglyceride in mmol/L	16 weeks
Secondary	low-density lipoprotein cholesterol	low-density lipoprotein cholesterol in mmol/L	16 weeks
Secondary	high-density lipoprotein cholesterol	high-density lipoprotein cholesterol in mmol/L	16 weeks