Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Prediabetes or Overweight
Conditions
Keywords
Tirzepetide, Type 2 Diabetes, Obesity, Real-world evidence, South Asia, Pakistan
Brief summary
This is a multicentre, prospective, observational study of the medicine tirzepatide as it is used in routine clinical care in Pakistan. Tirzepatide is already approved for type 2 diabetes and for obesity, but there is very little information on how it works for people in South Asia, and none from Pakistan specifically. This study aims to fill that gap. The study will follow 330 adults who are starting tirzepatide as part of their normal treatment, across ten diabetes and endocrinology centres in Pakistan. Everyone taking part has obesity, and they are grouped into three cohorts based on their blood sugar status at the start: obesity without diabetes, prediabetes with obesity, and type 2 diabetes with obesity. The study does not change anyone's treatment. The treating doctor decides whether to prescribe tirzepatide, at what dose, and for how long. The study simply observes and records what happens over 24 weeks, with assessments at the start, at Weeks 12 to 14, and at Weeks 24 to 26. The main things measured are the change in blood sugar control (HbA1c) in the diabetes cohort, and the change in body weight in the obesity and prediabetes cohorts. The study also looks at changes in blood pressure, cholesterol, and other measures, how well people stay on treatment, any side effects, and how participants feel about their treatment and quality of life. The findings will help doctors understand how tirzepatide performs in real-world care in Pakistan and inform its use in similar populations.
Detailed description
Tirzepatide's pivotal trials enrolled very few South Asian participants and no Pakistani sites, while Pakistan carries one of the world's highest diabetes burdens. This study provides real-world effectiveness, safety, and patient-reported outcome data from Pakistani routine care to address that gap.
Interventions
None listed
Sponsors
Universiti Sains Malaysia
BF Biosciences Pvt Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult aged 18 years or older * Obesity (BMI ≥ 30) meeting one cohort definition * Baseline HbA1c available to confirm cohort * Initiating tirzepatide as part of routine clinical care, decided independently of the study * No prior lifetime use of tirzepatide * Washout of at least 8 weeks from any GLP-1 or dual GIP/GLP-1 receptor agonist, if previously used * Baseline retinal (eye) screening completed * Able and willing to provide written informed consent
Exclusion criteria
* Type 1 or secondary diabetes * Any prior tirzepatide use * Proliferative diabetic retinopathy or clinically significant macular oedema * Pregnancy or breastfeeding * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) * Active malignancy, or a major cardiovascular event within the past 3 months * Inability to undergo retinal assessment * Mental incapacity or language barrier preventing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in body weight (obesity and prediabetes cohorts) | Baseline to Week 26 | Mean percentage change in body weight from baseline to Week 26 in the combined obesity and prediabetes cohorts, analysed using a mixed model for repeated measures. |
| Change in HbA1c (type 2 diabetes cohort) | Baseline to Week 26 | Mean change in glycated haemoglobin (HbA1c) from baseline to Week 24 in the type 2 diabetes with obesity cohort, analysed using a mixed model for repeated measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | Baseline to Week 26 | Mean change in body mass index (BMI) from baseline to Week 26. |
| Change in waist circumference | Baseline to Week 26 | Mean change in waist circumference (cm) from baseline to Week 26 |
| Change in blood pressure | Baseline to Week 26 | Mean change in systolic and diastolic blood pressure from baseline to Week 26. |
| Change in lipid profile | Baseline to Week 26 | Mean change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides from baseline to Week 26 |
| Treatment persistence | Baseline to Week 26 | Proportion of participants persisting on tirzepatide, and time to discontinuation, over 26 weeks. |
Countries
Pakistan
Contacts
CONTACTDr Quanita Tayyab, MBBS
CONTACTMuhammad Daoud Butt, PhD
PRINCIPAL_INVESTIGATORMuhammad Daoud Butt, PhD
Universiti Sains Malaysia
STUDY_CHAIRAbdul Basit, MBBS
Indus Hospital Health Network
Outcome results
None listed