UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059367 |
|---|---|
| Receipt number | R000067900 |
| Scientific Title | Single center Prospective Study of Tirzepatide in Adults with Obesity and MASLD: Co-primary Endpoints on Weight, Liver Biochemistry, and Histology |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/10 14:19:13 |
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Basic information
Public title
A Single-Center Prospective Interventional Study of Tirzepatide in Obese Patients with steatotic liver disease: Exploring Its Effects on Body Weight, Liver Function, and Histology
Acronym
A Single-Center Prospective Interventional Study of Tirzepatide in Obese Patients with steatotic liver disease
Scientific Title
Single center Prospective Study of Tirzepatide in Adults with Obesity and MASLD: Co-primary Endpoints on Weight, Liver Biochemistry, and Histology
Scientific Title:Acronym
Single center Prospective Study of Tirzepatide in Adults with Obesity and MASLD
Region
| Japan |
Condition
Condition
Obesity patients with MASLD
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to systematically assess the short- to mid-term efficacy and safety of tirzepatide in obese patients with MASLD, using body weight, liver function, and liver histology as co-primary endpoints.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Percent change in body weight from baseline at 6 months.
2)Percent change in alanine aminotransferase (ALT) from baseline at 6 months.
3)Proportion of patients showing a over 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis on repeat liver biopsy at 6-12 months.
Key secondary outcomes
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
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age between 18 and 75 years
Body mass index (BMI) over 27 kg/m2, consistent with domestic regulatory criteria
Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) according to current clinical practice guidelines
The principal investigator determines that tirzepatide is clinically indicated
Basic Conditions
Diagnosis of hypertension, dyslipidemia, or type 2 diabetes mellitus
Lifestyle Modification
Insufficient response to at least 6 months of lifestyle intervention, including dietary and exercise therapy
BMI and Obesity-Related Comorbidities
Eligible participants must meet one of the following conditions:
BMI over 35 kg/m2, or
BMI over 27 kg/m2 with two or more obesity-related comorbidities, including:
Impaired glucose tolerance (diabetes, borderline diabetes, etc.)
Dyslipidemia
Hypertension
Hyperuricemia or gout
Coronary artery disease (myocardial infarction, angina pectoris)
Cerebral infarction or transient ischemic attack
Nonalcoholic fatty liver disease (NAFLD) / Nonalcoholic steatohepatitis (NASH)
Menstrual disorders or female infertility
Obstructive sleep apnea syndrome (SAS)
Obesity hypoventilation syndrome
Musculoskeletal disorders (e.g., osteoarthritis of the knee or hip)
Obesity-related kidney disease
Written informed consent obtained prior to enrollment
Baseline liver biopsy performed within 3 months before study initiation or scheduled to be performed prior to treatment
Key exclusion criteria
Decompensated liver cirrhosis (Child-Pugh class B or C)
History of pancreatitis, or active gallstones or cholecystitis
Planned initiation of other anti-obesity or incretin-based medications within the next 6 months
Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2, severe heart failure, active malignancy, or pregnancy/lactation
Any other condition that the principal investigator considers inappropriate for study participation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Yamashita |
Organization
nagano red cross hospital
Division name
Gastroenterology
Zip code
380-8582
Address
5-22-1 Wakasato, Nagano-shi, Nagano-ken, Japan
TEL
026-226-4131
yyamashita@nagano-rch.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yamashita |
Organization
nagano red cross hospital
Division name
Gastroenterology
Zip code
380-8582
Address
5-22-1 Wakasato, Nagano-shi, Nagano-ken, Japan
TEL
026-226-4131
Homepage URL
yyamashita@nagano-rch.jp
Sponsor or person
Institute
nagano red cross hospital
Institute
Department
Personal name
Funding Source
Organization
nagano red cross hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
nagano red cross hospital
Address
5-22-1 Wakasato, Nagano-shi, Nagano-ken, Japan
Tel
026-226-4131
yyamashita@nagano-rch.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
| 2025 | Year | 10 | Month | 17 | 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 | 09 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 17 | 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 | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067900
