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

NCT07809568 | Not Yet Recruiting DMC

• 2 other identifiers: USM_2026_03_029R504-LR-GAL008-2600000333-B158
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Tirzepetide; Type 2 Diabetes; Obesity; Real-world evidence; South Asia; Pakistan

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to Week 26

Secondary Outcomes (5)

• Change in BMI

  Baseline to Week 26

• Change in waist circumference

  Baseline to Week 26

• Change in blood pressure

  Baseline to Week 26

• Change in lipid profile

  Baseline to Week 26

• Treatment persistence

  Baseline to Week 26

Other Outcomes (7)

• Adverse events and serious adverse events

  Baseline to Week 26

• Medication adherence

  Baseline to Week 26

• Change in health-related quality of life (SF-36v2)

  Baseline to Week 26

Study Arms (3)

Obesity without diabetes

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.

Prediabetes with obesity

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.

Type 2 diabetes with obesity

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• BF Biosciences Pvt Ltd: collaborator

Study Sites (9)

Bolan Medical Complex

Quetta, Balouchistan, Pakistan

Location

Khyber Medical University

Peshawar, KPK, Pakistan

Location

Capital Development Authority (CDA) Hospital

Islamabad, Punjab Province, Pakistan

Location

Jinnah Postgraduate Medical Centre

Lahore, Punjab Province, Pakistan

Location

Hanif Medical Complex

Rawalpindi, Punjab Province, Pakistan

Location

Aga Khan University Hospital (AKUH)

Karachi, Sindh, Pakistan

Location

Indus Hospital Health Network

Karachi, Sindh, Pakistan

Location

OMI Hospital

Karachi, Sindh, Pakistan

Location

Chandka Medical College

Lārkāna, Sindh, Pakistan

Location

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Daoud Butt, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

• Abdul Basit, MBBS

  Indus Hospital Health Network

  STUDY CHAIR

Central Study Contacts

Dr Quanita Tayyab, MBBS

CONTACT

+92 331 5119873; quanitatayyab10@gmail.com

Muhammad Daoud Butt, PhD

CONTACT

+60-16-7054015; daoudbutt@usm.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 26 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

PA (9)