UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060049 |
|---|---|
| Receipt number | R000068617 |
| Scientific Title | Prospective observational study of changes in obesity-related quality of life and work productivity among users of anti-obesity medications |
| Date of disclosure of the study information | 2025/12/11 |
| Last modified on | 2025/12/11 10:40:02 |
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Basic information
Public title
Prospective observational study of quality of life and work productivity in people treated with obesity medications
Acronym
J-ORBIT PRO study
Scientific Title
Prospective observational study of changes in obesity-related quality of life and work productivity among users of anti-obesity medications
Scientific Title:Acronym
J-ORBIT PRO study
Region
| Japan |
Condition
Condition
Obesity disease
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate changes in obesity-related quality of life and work productivity, and their association with body weight change, in patients with obesity treated with semaglutide or tirzepatide.
Basic objectives2
Others
Basic objectives -Others
To clarify the impact of weight loss achieved by anti-obesity medications on patient-reported outcomes, including obesity-related quality of life and work productivity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in obesity-related quality of life as assessed by the IWQOL-Lite-CT total score from baseline (week 0) to the end of the treatment period (week 68 for semaglutide [Wegovy] or week 72 for tirzepatide [Zepbound]).
Key secondary outcomes
Changes in IWQOL-Lite-CT total and domain scores from baseline to weeks 24 and 52, the end of the treatment period, and 24 weeks after treatment discontinuation.
Changes in patient-reported outcomes assessed by the WPAI, SF-12 v2, and IPAQ-SF from baseline to weeks 24 and 52, the end of the treatment period, and 24 weeks after treatment discontinuation.
Changes in anthropometric measures (body weight, BMI, waist circumference) and relevant laboratory parameters from baseline to each assessment time point.
Incidence of adverse events at each assessment time point.
Associations of the percentage of weight loss at the end of treatment and the percentage of weight regain after treatment discontinuation with changes in obesity-related quality of life and work productivity.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. 18 years of age or older
2. Individuals newly initiating use of semaglutide (Ugovi) or tirzepatide (Zepbound) as obesity treatment drugs
3. Individuals who have provided written consent for this study
Key exclusion criteria
1. Individuals who have difficulty completing the questionnaire
2. Individuals undergoing treatment for malignant tumors
3. Individuals undergoing dialysis
4. Individuals who are pregnant or wish to become pregnant
5. Individuals who have undergone weight loss/metabolic improvement surgery (such as sleeve gastrectomy) or who are scheduled to undergo such surgery
6. Individuals suspected of off-label use
7. Individuals deemed inappropriate for this study by the principal investigator
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5860
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Nishikage |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5860
Homepage URL
nskg@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Yushi Hirota
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine, Medical Ethics Committee
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
kansatsu@med.kobe-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
| 2025 | Year | 12 | Month | 11 | 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 | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the time of registration, this study has not yet obtained IRB approval and planned for review by the Ethics Committee of Kobe University Hospital. Recruitment will not start before IRB approval. Information such as recruitment status and study start date will be updated after approval.
Management information
Registered date
| 2025 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068617
