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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000461
• EU PAS number:
  EUPAS1000000461
• Study ID:
  1000000461
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a single-country, single arm, prospective, non-interventional study among Chinese participants who are overweight or have obesity with newly administered tirzepatide in a real-world clinical setting. This is a new user design study that identifies participants who initiate tirzepatide and begins 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, whichever comes first. The incidence of AEs and SAEs will be described.; This PMSS is also designed to describe the demographics, clinical characteristics and treatment patterns, as well as effectiveness on weight management and improvement of comorbidities in participants with overweight or obesity newly treated with tirzepatide.;
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned: 27/01/2025

Actual: 27/01/2025

Study start date

Planned: 29/08/2025

Data analysis start date

Planned: 09/05/2028

Date of final study report

Planned: 09/08/2028

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable