UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060122 |
|---|---|
| Receipt number | R000068711 |
| Scientific Title | Efficacy and Safety of Tirzepatide step-up therapy on body weight and body composition in people with obesity : A multicenter intervention study |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/18 16:24:39 |
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Basic information
Public title
Effect of Tirzepatide on body weight and body composition in people with obesity
Acronym
Effect of Tirzepatide on body weight and body composition in people with obesity
Scientific Title
Efficacy and Safety of Tirzepatide step-up therapy on body weight and body composition in people with obesity : A multicenter intervention study
Scientific Title:Acronym
IZU (0besity) STUDY
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of Tirzepatide treatment on body weight and body composition in people with obesity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Effect of Tirzepatide on body weight in participants with obesity.
Key secondary outcomes
1. Incidence and profile of adverse events associated with tirzepatide administration in patients with obesity
2. Effects of tirzepatide administration on body composition in patients with obesity, including the following parameters:
muscle mass, skeletal muscle mass, skeletal muscle index (SMI), fat mass, body fat percentage, visceral fat level, basal metabolic rate, bone mineral content, and basal metabolic rate
3. Effects of tirzepatide administration on fingertip advanced glycation end products (AGEs) score in patients with obesity
4. Effects of tirzepatide administration on the following metabolic parameters in patients with obesity:
HbA1c, fasting plasma glucose, systolic and diastolic blood pressure, lipid profile (LDL-C, HDL-C, triglycerides), estimated glomerular filtration rate (eGFR), liver function parameters (AST, ALT, GGT), FIB-4 index, fasting insulin, fasting C-peptide (CPR), HOMA-R, insulinogenic index assessed by a 75-g oral glucose tolerance test (OGTT), serum total protein, serum albumin, and changes in concomitant medications and the number of medications from baseline.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After six months of standard obesity management, including dietary counseling and exercise therapy, subcutaneous administration of tirzepatide (2.5 mg once weekly) will be initiated.
While monitoring body weight changes and tolerability, the dose may be escalated as appropriate (to 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg once weekly), with the principle that each dose level is maintained for a minimum of four weeks before further escalation.
Following a total treatment period of 72 weeks, the intervention will be discontinued. Subsequently, physical and metabolic changes will be continuously monitored for an additional six months, and up to one year if patient consent is obtained.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The target sample size across all participating institutions is 40 patients. Eligible participants will be those who meet the inclusion criteria listed below and do not meet any of the exclusion criteria.
Inclusion Criteria
Patients diagnosed with one or more of the following conditions-type 2 diabetes mellitus, hypertension, and/or dyslipidemia-and currently receiving pharmacological treatment.
Patients who have received nutritional counseling at least once every two months for a minimum of six months, in accordance with an established treatment plan.
BMI more than 35 kg/m2, or
BMI more than 27 kg/m2 with two or more obesity-related health complications (see below).
Obesity-Related Health Complications
Impaired glucose tolerance (type 2 diabetes mellitus/impaired glucose tolerance)
Dyslipidemia
Hypertension
Hyperuricemia/gout
Coronary artery disease
Cerebral infarction / transient ischemic attack
Non-alcoholic fatty liver disease
Menstrual disorders / female infertility
Obstructive sleep apnea syndrome / obesity hypoventilation syndrome
Musculoskeletal disorders (osteoarthritis / spondylosis)
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, Director
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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、西日本病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 18 | 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
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 12 | 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
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068711
