An observational study in Prediabetes or Overweight, Obesity Type 2 Diabetes Mellitus and Obesity & Overweight, sponsored by Universiti Sains Malaysia. Not yet recruiting at 9 sites in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Universiti Sains Malaysia · Observational
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.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 330 is above the median of 224 across 129 observational studies indexed under Prediabetic State.
Browse Prediabetic State studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 years or older with obesity (BMI ≥ 30) who are initiating tirzepatide as part of routine clinical care at ten diabetes and endocrinology centres in Pakistan. Participants are grouped into three cohorts by glycaemic status at entry: obesity without diabetes (HbA1c \< 5.7%), prediabetes with obesity (HbA1c 5.7-6.4%), and type 2 diabetes with obesity (diagnosed at least 6 months prior).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with obesity (BMI ≥ 30) and normoglycaemia (HbA1c \< 5.7%), with no diabetes diagnosis, initiating tirzepatide in routine clinical care. Followed for weight and metabolic outcomes over 26 weeks.
Adults with obesity (BMI ≥ 30) and prediabetes (HbA1c 5.7-6.4%), initiating tirzepatide in routine clinical care. Followed for weight and metabolic outcomes over 26 weeks.
Adults with obesity (BMI ≥ 30) and type 2 diabetes mellitus diagnosed at least 6 months prior, initiating tirzepatide in routine clinical care. Followed for change in glycaemic control (HbA1c) over 26 weeks.
This study also gives Tirzepatide. No intervention listed here names it: that was found by reading the record.
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
Mean change in total cholesterol (mg/dL)
Mean change in total cholesterol 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
Mean change in LDL cholesterol (mg/dL)
Mean change in low-density lipoprotein (LDL) cholesterol from baseline to Week 26.
Time frame: Baseline to Week 26
Mean change in HDL cholesterol (mg/dL)
Mean change in high-density lipoprotein (HDL) cholesterol from baseline to Week 26.
Time frame: Baseline to Week 26
Mean change in triglycerides (mg/dL)
Mean change in triglycerides from baseline to Week 26.
Time frame: Baseline to Week 26
Adverse events and serious adverse events
Incidence, type, and severity of adverse events and serious adverse events over 26 weeks.
Time frame: Baseline to Week 26
Medication adherence
Change in medication adherence, measured by the 8-item Morisky Medication Adherence Scale (MMAS-8), from baseline to Week 26. 8-item Morisky Medication Adherence Scale (MMAS-8); scores range 0 to 8, higher scores indicate better adherence.
Time frame: Baseline to Week 26
Change in health-related quality of life (SF-36v2)
Mean change in the 36-Item Short Form Health Survey version 2 (SF-36v2) score from baseline to Week 24, in all cohorts. Scores range from 0 to 100; higher scores indicate better health-related quality of life.
Time frame: Baseline to Week 26
Change in weight-related quality of life (OWLQOL)
Mean change in the Obesity and Weight-Loss Quality of Life (OWLQOL) questionnaire score from baseline to Week 26, in the obesity and prediabetes cohorts. Higher scores indicate better weight-related quality of life.
Time frame: 26 Weeks
Change in eating behaviour and appetite (EBAQ)
Mean change in the Eating Behaviour and Appetite Questionnaire (EBAQ) total score from baseline to Week 26, in the obesity and prediabetes cohorts. The EBAQ total score is transformed to a 0 to 100 scale; higher scores indicate better outcomes (reduced appetite and greater eating control).
Time frame: Baseline to Week 26
Change in diabetes treatment satisfaction (DTSQs)
Mean change in the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs), from baseline to Week 26, in the type 2 diabetes and treated prediabetes participants. Higher scores indicate greater treatment satisfaction.
Time frame: Week 26
Diabetes treatment satisfaction, change version (DTSQc)
Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), measured at the interim and final visits in the type 2 diabetes and treated prediabetes participants. Higher scores indicate improved treatment satisfaction relative to previous treatment. Not administered at baseline.
Time frame: Week 30
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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