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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05556577
Other study ID # 2020-084
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 15, 2022
Est. completion date March 15, 2023

Study information

Verified date November 2022
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this follow-up (FU) study is to examine trajectory of body weight impacted by self-reported diet patterns and physical activities in 6 months at 3 monthly intervals from treatment cessation among patients who completed a pharmacotherapy trial. In addition, patient self-reported diet patterns and physical activities at respective time points will be described.


Description:

This is a real-world prospective observational study with primary data collection. All participants with a background be recommended to adopt lifestyle intervention as chronic weight management in China clinical practice. This FU study will enroll patients who completed SURMOUNT-CN trials, with planed study duration of 6 months. No investigational medicine is applied in this prospective follow-up study. Patients are requested to report body weight, waist circumferences, blood pressure, diet, physical activities, and laboratory results if available, at 3 monthly intervals during the 6-month follow-up period. Patients are also asked if they receive any Anti-Obesity medication (AOM) or participate in any interventional clinical trials indicated for weight management during study period. Summary statistics will be respectively applied to examine changes from trial baseline (time at trial randomization, week 0) and study baseline (time at 52 weeks from trial randomization, week 52) to each scheduled follow-up (at week 65 and week 78) by study arms in SURMOUNT-CN trial.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants. Exclusion Criteria: - Those in the SURMOUNT-CN trial who denied to participant.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
investigational medicine product (IMP)
Investigational medicine product (IMP) received at SURMOUNT-CN trial
Other:
placebo
Placebo received at SURMOUNT-CN trial

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary the change in body weight at week 65 and week 78 from study baseline
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