Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversiti Sains Malaysia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Type 1 or secondary diabetes
Any prior tirzepatide use
Proliferative diabetic retinopathy or clinically significant macular oedema
Pregnancy or breastfeeding
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
330 Participants
are grouped into 3 trial groupsGroup A: Obesity without diabetes
Group B: Prediabetes with obesity
Group C: Type 2 diabetes with obesity
Trial outcomes
Primary outcomes
1
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 262
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 26Secondary outcomes
1
Change in BMI
Mean change in body mass index (BMI) from baseline to Week 26.
Time frame
Baseline to Week 262
Change in waist circumference
Mean change in waist circumference (cm) from baseline to Week 26
Time frame
Baseline to Week 263
Change in blood pressure
Mean change in systolic and diastolic blood pressure from baseline to Week 26.
Time frame
Baseline to Week 264
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 26Other outcomes
1
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 262
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 263
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 264
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 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiti Sains Malaysia
Lead sponsor
BF Biosciences Pvt Ltd
Collaborator
Source ClinicalTrials.gov
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