Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes

ClinicalTrials.gov ID

NCT07809568

Lead Sponsor

Universiti Sains MalaysiaOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

330Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Dec 28, 2027Estimated

Completion Date

Mar 31, 2028Estimated

Official Title

Real-World Effectiveness, Safety, and Patient-Reported Outcomes of Tirzepatide in Adults With Type 2 Diabetes Mellitus, Obesity, or Prediabetes in Pakistan: A Multicentre, Prospective, Observational Cohort Study

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.

• Prediabetes or Overweight
• Obesity Type 2 Diabetes Mellitus
• Obesity & Overweight

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Universiti Sains MalaysiaOTHER

Collaborators

BF Biosciences Pvt LtdUNKNOWN

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quanitatayyab10@gmail.com+92 331 5119873

quanitatayyab10@gmail.com+92 331 5119873

quanitatayyab10@gmail.com+92 331 5119873

quanitatayyab10@gmail.com+92 331 5119873

quanitatayyab10@gmail.com+92 331 5119873

muhammaddaoud10@yahoo.com03215150497

quanitatayyab10@gmail.com+92 331 5119873