UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053714 |
|---|---|
| Receipt number | R000061294 |
| Scientific Title | A study on the safety and efficacy of semaglutide in obese patients |
| Date of disclosure of the study information | 2024/02/27 |
| Last modified on | 2024/02/26 19:36:42 |
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Basic information
Public title
A study on the safety and efficacy of semaglutide in obese patients
Acronym
A study on the safety and efficacy of semaglutide in obese patients
Scientific Title
A study on the safety and efficacy of semaglutide in obese patients
Scientific Title:Acronym
A study on the safety and efficacy of semaglutide in obese patients
Region
| Japan |
Condition
Condition
Obsesity patients
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the safety and efficacy of semaglutide injection in obese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in body weight at 22-26 weeks after semaglutide.
Key secondary outcomes
The change in time in range (TIR, 70-180 mg/dL)
The change in time below range (TBR, <70 mg/dL)
The change in time below range (TBR, <54 mg/dL)
The change in time above range (TAR, >180 mg/dL)
The change in time above range (TAR, >240 mg/dL)
The change in mean sensor glucose level by CGM
The change in %CV (coefficient of variation) of sensor glucose level
The change in SD (standard deviation) of sensor glucose level
The change in glucose management indicator (GMI)
The change in glycemia risk index (GRI)
The change in the frequency of hypoglycemic events
The change in HbA1c and glycated albumin
The change in C-peptide index
The change in the dosage of insulin
The change in body composition (fat mass, muscle mass. lean body mass and waist circumference)
The change in blood pressure
The change in non-HDL cholesterol
The difference in efficacy of semaglutide between patients with and without sleep apnea
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Semaglutide injection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Obesity
2. Patients scheduled for semaglutide administration
3. Indications for semaglutide: Obesity, provided that the patient has hypertension, dyslipidemia, and/or type 2 diabetes, and dietary and exercise therapy alone are not enough to control body weight and metabolic disorders, limited to cases meeting the following criteria:
> BMI is 27 kg/m2 or higher and has two or more obesity-related health issues
> BMI is 35 kg/m2 or higher
Key exclusion criteria
1. Severe anemia (Hb level < 10 g/dL)
2. Patients using implanted medical devices (such as pacemakers)
3. Patients with active malignant tumors
4. Participants for whom the principal investigator or collaborating investigator has deemed participation in this clinical study inappropriate
5. Pregnant women or women who may be pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Department of Endocrinology, Diabetes and Metabolisim
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical School Ethics Committee
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061294
