Trial · Interventional

Status unknownPhase 4Registry data

Comparison of Body Weight Change Through Different Smeglutide Administration Methods

NCTNCT05616052Other id2022-10-weight loss-SPHCC

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 80 participants (estimated)
Sponsor: Huashan Hospital · Other
Design: Randomized · Single masking
Countries: 1 country
China
Start: 1 Dec 2022 (estimated)
Primary completion: 1 Dec 2023 (estimated)
Completion: 1 Dec 2023 (estimated)
First posted: 15 Nov 2022
Last update posted: 15 Nov 2022
Conditions: Weight Change, Body

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 4
Comparison of Body Weight Change Through Different Smeglutide Administration Methods
NCT05616052
est. 1 Dec 2022 to est. 1 Dec 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

SemaglutideDrug

Arms2

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..
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

Primary outcomes1

Outcomes the sponsor listed as primary.

weight change in kilograms
Time frame · 16 weeks
Registry description
weight change in kilograms before and after treatment

Secondary outcomes(15)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

13 results

Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity.

Blundell et al. 2017Diabetes, obesity & metabolismcited by 539

PMID 28266779PMC5573908DOI 10.1111/dom.12932PUB-28266779

Free to read · publisher termsCC BY-NC-ND13 results

Read at source See results (13)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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