Body weight and waist circumference change in midlife women treated with tirzepatide by menopausal status: an observational study in UK primary care

Study identification

• EU PAS number:
  EUPAS1000000983
• Study ID:
  1000000983
• Official title and acronym:
  Body weight and waist circumference change in midlife women treated with tirzepatide by menopausal status: an observational study in UK primary care
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study aims to examine the change in weight-related and cardiometabolic features after initiation of tirzepatide (TZP) for management of overweight and obesity in midlife women (40–60 years old) resident in the UK, according to their baseline menopause status (pre-, peri- and post-menopausal). The study will consist of a retrospective, longitudinal cohort study in the UK primary care setting, using data from the Optimum Patient Care Research Database (OPCRD). Characteristics at the time of TZP initiation (baseline) will be reported, including clinical and sociodemographic features. The main outcomes of interest are change in body weight, waist circumference, waist/height index and cardiometabolic risk markers (including blood pressure and lipid profiles) at month 6 and 12 after TZP initiation. The proportion of women achieving different weight reduction targets will also be reported.
• Study status:
  Planned

Research institutions and networks

Institutions

Eli Lilly and Company

Costello Medical Ltd

Study timelines

Date when funding contract was signed

Planned:28/05/2025

Actual:28/05/2025

Study start date

Planned:01/10/2026

Date of final study report

Planned:01/02/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Study funded by Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Anonymised Data Ethics & Protocol Transparency Committee (ADEPT) Protocol Reference: PROTOCOL2372;
ADEPT Approval Reference: ADEPT0626