NCT05616052

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

October 5, 2022

Last Update Submit

November 6, 2022

Conditions

Weight Change, Body

Outcome Measures

Primary Outcomes (1)

  • weight change in kilograms

    weight change in kilograms before and after treatment

    16 weeks

Secondary Outcomes (15)

  • patient compliance in rate

    16 weeks

  • waist hip circumference in centimeter

    16 weeks

  • number of adverse events

    16 weeks

  • appetite change in score

    16 weeks

  • quality of life improvement in score

    16 weeks

  • +10 more secondary outcomes

Study Arms (2)

standard arm

ACTIVE COMPARATOR

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..

Drug: Semaglutide

titration arm

ACTIVE COMPARATOR

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

Drug: Semaglutide

Interventions

SemaglutideDRUG

treatment with different dosage regimes

Also known as: dosage regime
standard armtitration arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (3)

  • 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.

    PMID: 34097869BACKGROUND

  • 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.

    PMID: 10702749BACKGROUND

  • 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.

    PMID: 28266779BACKGROUND

MeSH Terms

Conditions

Body Weight Changes

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • xiaolong zhao

    Shanghai Public Health Clinical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaolong zhao

CONTACT

86-13501827230xiaolongzhao@163.com

xiaolong zhao

CONTACT

86-021-37990333

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of endocrinology department

Study Record Dates

First Submitted

October 5, 2022

First Posted

November 15, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)