Clinical trial NCT05616052: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Weight Change, Body
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: weight change in kilograms
timeFrame: 16 weeks
Secondary outcomes:
measure: patient compliance in rate
timeFrame: 16 weeks
measure: waist hip circumference in centimeter
timeFrame: 16 weeks
measure: number of adverse events
timeFrame: 16 weeks
measure: appetite change in score
timeFrame: 16 weeks
measure: quality of life improvement in score
timeFrame: 16 weeks
measure: body fat in percentage
timeFrame: 16 weeks
measure: body composition of lean mass in kilogram
timeFrame: 16 weeks
measure: blood pressure in mmHg
timeFrame: 16 weeks
measure: blood lipid in concentration
timeFrame: 16 weeks
measure: fasting blood glucose level
timeFrame: 16 weeks
measure: HOMA-Beta value
timeFrame: 16 weeks
measure: total cholesterol in mmol/L
timeFrame: 16 weeks
measure: triglyceride
timeFrame: 16 weeks
measure: low-density lipoprotein cholesterol
timeFrame: 16 weeks
measure: high-density lipoprotein cholesterol
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: xiaolong zhao
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.