UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063631 |
|---|---|
| Receipt number | R000072824 |
| Scientific Title | Bridging Specialized Obesity Care and Community Follow-up After Anti-Obesity Medication Discontinuation (BRIDGE Study) |
| Date of disclosure of the study information | 2026/11/14 |
| Last modified on | 2026/11/14 21:03:26 |
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Basic information
Public title
Prospective Observational Study of 6-Month Outcomes After Discontinuation of Anti-Obesity Medications in Patients with Severe Obesity (BRIDGE Study)
Acronym
BRIDGE Study
Scientific Title
Bridging Specialized Obesity Care and Community Follow-up After Anti-Obesity Medication Discontinuation (BRIDGE Study)
Scientific Title:Acronym
BRIDGE Study
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate body weight change from anti-obesity medication discontinuation to 6 months after discontinuation and to identify factors associated with weight regain in patients with obesity who initiate treatment with semaglutide (Wegovy) or tirzepatide (Zepbound).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent change in body weight from anti-obesity medication discontinuation to 6 months after discontinuation
Key secondary outcomes
Change in body weight (kg)
Change in body mass index (BMI)
Change in HbA1c
Change in LDL cholesterol
Change in HDL cholesterol
Change in triglycerides
Change in systolic blood pressure
Change in diastolic blood pressure
Change in skeletal muscle mass
Change in fat mass
Change in body fat percentage
Incidence of weight regain at 6 months after treatment discontinuation
Incidence of adverse events
Treatment discontinuation rate
Reasons for treatment discontinuation
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
Age >= 18 years at enrollment
Diagnosis of obesity
Initiation of treatment with Wegovy or Zepbound at our institution
Written informed consent obtained
Key exclusion criteria
Pregnancy or possible pregnancy
Active malignancy
Patients judged unsuitable by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Fujita |
Organization
Osaka General Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
558-8558
Address
Osaka Prefecture, Osaka City, Sumiyoshi Ward, Mandai Higashi 3-1-56
TEL
0666921201
fujita.yohei93@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Fujita |
Organization
Osaka General Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
558-8558
Address
Osaka Prefecture, Osaka City, Sumiyoshi Ward, Mandai Higashi 3-1-56
TEL
0666921201
Homepage URL
fujita.yohei93@gmail.com
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka General Medical Center
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
Osaka General Medical Center
Address
Osaka Prefecture, Osaka City, Sumiyoshi Ward, Mandai Higashi 3-1-56
Tel
0666921291
fujita.yohei93@gmail.com
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
| 2026 | Year | 11 | Month | 14 | 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
| 2026 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational cohort study conducted at the Department of Diabetes, Endocrinology and Metabolism, Osaka General Medical Center. The study evaluates clinical outcomes during treatment with Wegovy or Zepbound and for 6 months after treatment discontinuation in patients with obesity. No study-specific intervention will be performed, and analyses will be conducted using routinely collected clinical data.
Management information
Registered date
| 2026 | Year | 11 | Month | 14 | Day |
Last modified on
| 2026 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072824
