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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  tirzepatide
• Medical condition to be studied:
  Obesity

  Overweight

Population studied

• Short description of the study population:
  The study population consists of midlife women (40–60 years old) with obesity or overweight who newly initiate TZP in UK clinical practice between 1 Jan 2025–31 Mar 2026 in the Optimum Patient Care Research Database (OPCRD).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)

Study design details

• Study design:
  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).
• Main study objective:
  Primary objectives: ; 1. To investigate cardiometabolic and weight-related features, medications, and socio-demographic characteristics at baseline (date of first TZP initiation in primary care), stratified by baseline menopausal status (pre-, peri- and post-menopause); 2. To investigate change from baseline in weight-related outcomes and cardiometabolic risk markers at month 6 and 12 following initiation of TZP, stratified by baseline menopausal status (pre-, peri- and post-menopause); ; Secondary objectives:; 1. To describe TZP utilisation patterns stratified by baseline menopausal status (pre-, peri- and post-menopause), including dosing (additionally stratified by baseline glucose tolerance [normal, prediabetes and T2D]) and persistence; 2. To describe prevalence of concomitant medication use (including antidiabetic drugs, antihypertensive drugs and lipid-lowering drugs) at baseline and over follow-up, stratified by baseline menopausal status (pre-, peri- and post-menopause);
• Setting:
  The study will consider midlife (40–60-year-old) women with obesity or overweight who newly initiate TZP in UK clinical practice between 1 Jan 2025–31 Mar 2026. ; ; The following inclusion criteria will apply:; 1. Sex recorded as female; 2. Initiation of TZP treatment during 1 Jan 2025–31 Mar 2026; 3. Aged 40–60 years at index date (date of TZP initiation); 4. Eligibility to receive TZP for overweight or obesity according to its marketing authorisation, either:; a. Obesity (body mass index [BMI] ≥30), recorded within 18 months before index date, OR; b. Overweight (27≤BMI<30), recorded within 18 months before index date, and ≥1 diagnosis with a weight-related comorbidity ; ; The following exclusion criteria will apply:; 1. Less than 18 months of clinical data available prior to TZP initiation ; 2. Prescription for TZP or other incretin weight loss medication at any time prior to index; 3. Surgical weight-loss treatment at any time prior to index; 4. Weight loss of >5kg in the 3 months prior to index; 5. Dosage for the index prescription of TZP greater than 2.5mg; 6. Premature menopause (before age 40) recorded prior to index, whether occurring naturally or induced.; ; Stratification by baseline menopausal status will be considered throughout the study, with women categorised into one of three groups according to an algorithm based on age, clinical codes and prescription data: pre-menopausal, peri-menopausal, post-menopausal.;
• Outcomes:
  All outcomes will be reported by baseline menopausal status (pre-, peri- and post-menopause).; ; Primary outcomes:; 1. Baseline characteristics (socio-demographic characteristics, weight-related and cardiometabolic features [see below], obesity-related comorbidities, medications); 2. Change from baseline to months 6 and 12 in weight-related and cardiometabolic features (weight, waist circumference, waist/height index, total cholesterol, high density lipoprotein [HDL] cholesterol, low density lipoprotein [LDL] cholesterol, triglycerides, systolic blood pressure, diastolic blood pressure, haemoglobin A1c [HbA1c]); ; Secondary outcomes:; 1. TZP utilisation patterns (dosage at 3, 6, 9, 12 months; persistence); 2. Prevalence of other medication use at months 3, 6, 9 and 12 of follow-up (antidiabetic, antihypertensive and lipid-lowering drugs);
• Data analysis plan:
  Descriptive summary statistics will include:; • For categorical variables: number, number missing, frequency, and percentage (with the denominator excluding the number missing). ; • For continuous variables: number, number missing, mean, median, interquartile-range, standard deviation, standard error, and range; Results will be presented overall and as stratified by menopause group. Change from baseline in the clinical and cardiometabolic outcomes to month 6 and 12 will be analysed using one-sample t-tests to test whether the mean absolute change in the measures is different from zero. An analysis of variance (ANOVA) will be used to test whether the mean change from baseline differs significantly between menopause groups.If the change from baseline is non-normally distributed, the Wilcoxon signed-rank test will be used to test whether the change from baseline is symmetric around zerothe Kruskall Wallis or paired Mann Whitney U test will be applied to assess whether the distribution of change from baseline varies between menopause groups. ;