A Post-Marketing Safety Study of Mounjaro® (Tirzepatide) in Chinese Participants who are Overweight or have Obesity with or without Type 2 Diabetes Mellitus in a Real-World Setting

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  MOUNJARO
• Study drug International non-proprietary name (INN) or common name:
  TIRZEPATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BX16) tirzepatide

  tirzepatide

Population studied

• Short description of the study population:
  The study population includes overweight or obese Chinese adult participants (≥18 years of age) with or without T2DM and newly treated with tirzepatide Tirzepatide will be prescribed in a real-world clinical setting and administered according to the usual practices of the treating physicians.

Study design details

• Study design:
  This is a single-country, single arm, prospective, non-interventional study among Chinese overweight or obese participants with or without T2DM who are newly administered tirzepatide in real-world clinical setting.
• Main study objective:
  The primary objective is to describe the incidence of all adverse events (AEs) including SAEs among participants newly treated with at least 1 dose of tirzepatide during a maximum of 24 weeks of follow up from the initial administration of tirzepatide in real-world clinical practice in China.
• Setting:
  This is a single-country, single arm, prospective, non-interventional study among Chinese overweight or obese participants with or without T2DM who are newly administered tirzepatide in real-world clinical setting. This is a study that identifies participants who initiate tirzepatide and begin follow-up after the initiation of the treatment. The observation period for each case will be either up to 24 weeks from the initial administration of tirzepatide or until discontinuation of the study (e.g., participants discontinue tirzepatide before 24 weeks, participants withdraw their consent of the study, loss of follow up), whichever comes first. Based on collected AE and SAE data, the incidence of AEs and SAEs will be described. The relatedness to administration of tirzepatide will be determined by the investigator.; This PMSS is also designed to describe the demographics, clinical characteristics and treatment patterns as well as effectiveness on weight management and comorbidities improvement in participants with overweight or obesity newly treated with tirzepatide.;
• Comparators:
  N/A