Comparison of Body Weight Change Through Different Smeglutide Administration Methods

NCT ID: NCT05616052

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Weight Change, Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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..

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

treatment with different dosage regimes

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

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

treatment with different dosage regimes

Interventions

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Semaglutide

treatment with different dosage regimes

Intervention Type DRUG

Other Intervention Names

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dosage regime

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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xiaolong zhao

Professor of endocrinology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xiaolong zhao

Role: PRINCIPAL_INVESTIGATOR

Shanghai Public Health Clinical Center

Locations

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Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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xiaolong zhao

Role: CONTACT

86-13501827230

xiaolong zhao

Role: CONTACT

86-021-37990333

Facility Contacts

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xiaolong zhao

Role: primary

86-13501827230

References

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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.

Reference Type BACKGROUND
PMID: 34097869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10702749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28266779 (View on PubMed)

Other Identifiers

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2022-10-weight loss-SPHCC

Identifier Type: -

Identifier Source: org_study_id

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