Prospective observational study of quality of life and work productivity in people treated with obesity medications

Prospective observational study of changes in obesity-related quality of life and work productivity among users of anti-obesity medications - J-ORBIT PRO study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060049

Enrollment

140

Registered

2025-12-11

Start date

2026-04-20

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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]).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactSeiji Nishikage

Kobe University Graduate School of Medicine Division of Diabetes and Endocrinology, Department of Internal Medicine

nskg@med.kobe-u.ac.jp078-382-5860

Outcome results