NCT05556577

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

September 23, 2022

Last Update Submit

November 21, 2022

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

  • the change in body weight

    at week 65 and week 78 from study baseline

Interventions

investigational medicine product (IMP)DRUG

Investigational medicine product (IMP) received at SURMOUNT-CN trial

placeboOTHER

Placebo received at SURMOUNT-CN trial

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

You may qualify if:

  • All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

You may not qualify if:

  • Those in the SURMOUNT-CN trial who denied to participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

September 15, 2022

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share