UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061914 |
|---|---|
| Receipt number | R000070830 |
| Scientific Title | Switching from semaglutide to tirzepatide in obesity management: effects on body weight and metabolic parameters |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 15:14:49 |
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Basic information
Public title
Switching from semaglutide to tirzepatide in obesity management: effects on body weight and metabolic parameters
Acronym
SENBON PINES STUDY
Scientific Title
Switching from semaglutide to tirzepatide in obesity management: effects on body weight and metabolic parameters
Scientific Title:Acronym
SENBON PINES STUDY
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the effects of switching to tirzepatide on body weight, body composition, and metabolic parameters, as well as its safety, in patients who previously underwent obesity treatment with semaglutide and require retreatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in body weight and waist circumference during tirzepatide treatment
Key secondary outcomes
Incidence of adverse events associated with tirzepatide treatment
Effects of tirzepatide treatment on body composition, including:
muscle mass, skeletal muscle mass, skeletal muscle index (SMI), body fat mass, body fat percentage, visceral fat level, basal metabolic rate, bone mineral content, and resting basal metabolic rate (optional)
Effects of tirzepatide treatment on fingertip AGEs score
Effects of tirzepatide treatment on the following metabolic parameters and related factors:
HbA1c, fasting plasma glucose, systolic/diastolic blood pressure, lipid profile (LDL-C, HDL-C, TG), eGFR, liver function parameters (AST, ALT, GGT), FIB-4 index, fasting insulin, fasting CPR, HOMA-R, insulinogenic index based on the 75-g oral glucose tolerance test, serum total protein, serum albumin, baseline medication use, and changes in the number of medications after treatment initiation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who require retreatment after completing semaglutide therapy and express a preference to switch to tirzepatide treatment will receive tirzepatide.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with obesity who are receiving outpatient care at Aso Clinic or Kumamoto University Hospital and meet the following criteria:
Patients who have been diagnosed with at least one of the following conditions and are receiving pharmacotherapy: type 2 diabetes mellitus and/or hypertension and/or dyslipidemia.
Patients who have a history of nutritional counseling based on a treatment plan at least once every two months for at least six months.
Patients who have not achieved sufficient effects with diet and exercise therapy and who have a BMI of >=35, or a BMI of >=27 with two or more obesity-related health disorders.*
*Obesity-related health disorders:
1) Glucose intolerance, including type 2 diabetes mellitus or impaired glucose tolerance; 2) dyslipidemia; 3) hypertension; 4) hyperuricemia/gout; 5) coronary artery disease; 6) cerebral infarction/transient ischemic attack; 7) non-alcoholic fatty liver disease; 8) menstrual disorders/female infertility; 9) obstructive sleep apnea syndrome/obesity hypoventilation syndrome; 10) musculoskeletal disorders, including osteoarthritis and spondylosis deformans; and 11) obesity-related kidney disease.
Key exclusion criteria
1. Cases with obvious infection.
2. Cases of obvious chronic inflammatory diseases such as autoimmune diseases, or cases of long-term use of steroid drugs for treatment.
3. Cases diagnosed with advanced cancer.
4. Fresh case of cerebrovascular accident (within 12 weeks of onset).
5. Cases with liver dysfunction (ALT > 3 x facility upper limit).
6. Cases with complications that are judged to seriously impede the conduct of the study, such as respiratory disease, poorly controlled heart failure, or arrhythmia.
7. Cases with a history of alcoholism or drug addiction, or cases with psychosis or psychotic symptoms that make it difficult to participate in the study.
8. In other cases where the doctor in charge of the study determines that the subject is unsuitable for the safe conduct of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Aso |
Organization
ASO clinic
Division name
Director
Zip code
410-0041
Address
11-1 Tsutsui-machi, Numazu, Shizuoka
TEL
055-929-7575
info@aso-clinic.jp
Public contact
Name of contact person
| 1st name | Katsumi |
| Middle name | |
| Last name | Aso |
Organization
ASO Clinic
Division name
Secretariat
Zip code
410-0041
Address
11-1 Tsutsui-machi, Numazu, Shizuoka
TEL
055-929-7575
Homepage URL
https://aso-clinic.jp/
info@aso-clinic.jp
Sponsor or person
Institute
Aso clinic
Institute
Department
Personal name
Katsumi Aso
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Self funding
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ASO Clinic
Address
11-1 Tsutsui-machi, Numazu, Shizuoka
Tel
055-929-7575
info@aso-clinic.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
熊本大学病院（熊本）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070830
