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Weight Change, BodyPhase 4NCT05616052

Comparison of Body Weight Change Through Different Smeglutide Administration Methods

A Phase 4 study testing Semaglutide in people with Weight Change, Body, run by Huashan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Weight Change, Body
What is being tested?
Semaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Dec 2022to 1 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 ≤ age<75;
  • Overweight or obesity: meet either one of the following standards
  • Patients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension, hyperlipidemia, apnea syndrome, cardiovascular disease)
  • Simple obese patients with BMI ≥ 28kg/m2
  • Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for females

Who cannot join

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia type 2 (MEN-2) patients.
  • Patients with severe hypersensitivity to smeglutide or any other excipient component.
  • 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).
  • Triglyceride>5.6mmol/L;
  • Participants in other clinical drug trials in recent three months.
  • The range of weight change in recent 90 days is>5kg.
Show all 9Show fewer
  • Cushing's syndrome and abnormal thyroid function.
  • Pregnant or breastfed women.
  • The study doctor judged that it was not suitable to participate in the test.

Trial locations and contacts

1 site in 1 country.

xiaolong zhao contact

86-13501827230

xiaolongzhao@163.com

xiaolong zhao contact

86-021-37990333

China1 site

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality, 200000

    xiaolong zhao, 86-13501827230

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Semaglutide
Medical subject headings
Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Also called dosage regime

    treatment with different dosage regimes

Study groups in NCT05616052
Study groupRoleWhat they receive
standard armActive comparatorstandard 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..
Receives: Drug: Semaglutide
titration armActive comparatorTitration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight change in kilograms

    weight change in kilograms before and after treatment

    Measured: 16 weeks

Secondary outcomes (15)

  1. patient compliance in rate

    rate of participants dropout of the study（in percentage)

    Measured: 16 weeks

  2. waist hip circumference in centimeter

    waist hip circumference in centimeter

    Measured: 16 weeks

  3. 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, % )

    Measured: 16 weeks

  4. appetite change in score

    appetite change measures in appetite questionnaire (visual analogue scales in assessment of appetite sensations, Units on scale is millimeter)

    Measured: 16 weeks

  5. quality of life improvement in score

    quality of life improvement (in WHOQOL~BREF, Units on scale is point);

    Measured: 16 weeks

  6. body fat in percentage

    body fat in percentage

    Measured: 16 weeks

  7. body composition of lean mass in kilogram

    body composition in kilogram of lean mass

    Measured: 16 weeks

  8. blood pressure in mmHg

    blood pressure in mmHg

    Measured: 16 weeks

  9. blood lipid in concentration

    blood lipid in including (total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol in mmol/L),

    Measured: 16 weeks

  10. fasting blood glucose level

    fasting blood glucose in milli-mole per liter

    Measured: 16 weeks

  11. HOMA-Beta value

    the value of 20 × FINS/（FBG-3.5）

    Measured: 16 weeks

  12. total cholesterol in mmol/L

    total cholesterolin mmol/L

    Measured: 16 weeks

  13. triglyceride

    triglyceride in mmol/L

    Measured: 16 weeks

  14. low-density lipoprotein cholesterol

    low-density lipoprotein cholesterol in mmol/L

    Measured: 16 weeks

  15. high-density lipoprotein cholesterol

    high-density lipoprotein cholesterol in mmol/L

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616052
Sponsor's protocol ID
2022-10-weight loss-SPHCC
Status last verified
Nov 2022
First submitted
5 Oct 2022
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34097869

  • 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.

    PubMed 10702749

  • 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.

    PubMed 28266779

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide in people with Weight Change, Body, run by Huashan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact xiaolong zhao (86-13501827230, xiaolongzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight change in kilograms (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05616052, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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