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.
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.
Study Type
OBSERVATIONAL
Enrollment
330
Bolan Medical Complex
Quetta, Balouchistan, Pakistan
Khyber Medical University
Peshawar, KPK, Pakistan
Capital Development Authority (CDA) Hospital
Islamabad, Punjab Province, Pakistan
Jinnah Postgraduate Medical Centre
Lahore, Punjab Province, Pakistan
Hanif Medical Complex
Rawalpindi, Punjab Province, Pakistan
Aga Khan University Hospital (AKUH)
Karachi, Sindh, Pakistan
Indus Hospital Health Network
Karachi, Sindh, Pakistan
OMI Hospital
Karachi, Sindh, Pakistan
Chandka Medical College
Lārkāna, Sindh, Pakistan
Percentage change in body weight (obesity and prediabetes cohorts)
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.
Time frame: Baseline to Week 26
Change in HbA1c (type 2 diabetes cohort)
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.
Time frame: Baseline to Week 26
Change in BMI
Mean change in body mass index (BMI) from baseline to Week 26.
Time frame: Baseline to Week 26
Change in waist circumference
Mean change in waist circumference (cm) from baseline to Week 26
Time frame: Baseline to Week 26
Change in blood pressure
Mean change in systolic and diastolic blood pressure from baseline to Week 26.
Time frame: Baseline to Week 26
Change in lipid profile
Mean change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides from baseline to Week 26
Time frame: Baseline to Week 26
Treatment persistence
Proportion of participants persisting on tirzepatide, and time to discontinuation, over 26 weeks.
Time frame: Baseline to Week 26
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