Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Overweight
Obesity
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

190
Study design details

Main study objective

To examine the change in body weight by treatment arms from week 52 to week 56, week 65 and to week 78 following discontinuation of SURMOUNT-CN study treatment. To examine the change in waist circumferences by treatment arms from week 52 to week 56, week 65 and to week 78 following discontinuation of SURMOUNT-CN treatment.

Outcomes

The absolute and relative change in body weight, the absolute change in waist circumferences

Data analysis plan

Descriptive statistics will be used to summarise study outcomes only among eligible analysis population. For continuous variables, mean and standard deviations (SD) or median and range (minimum, maximum) will be summarized. Frequencies and proportions will be reported for categorical variables. In addition, if data permit, regression analysis will be used to test the association between the weight change starting from treatment discontinuation at week 52 and variables of interest (e.g. randomized treatment, weight loss during trial period, etc.), while adjusting for selected covariates from general characteristics. Clinical indicators of interest will be defined as protocol-defined AEs and summarized by cut-off values as per Chinese clinical guidelines. The numbers of patients with protocol-defined AE categories (by low, high) at week 52, week56, week 65 and week 78 will be summarized by SURMOUNT-CN study treatment arms.