Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07809568

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prediabetes or Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Obesity Type 2 Diabetes Mellitus Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolan Medical Complex, Quetta, Balouchistan, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage change in body weight (obesity and prediabetes cohorts)

    Time frame: Baseline to Week 26

    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.

  2. Change in HbA1c (type 2 diabetes cohort)

    Time frame: Baseline to Week 26

    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.

Secondary outcomes

  1. Change in BMI

    Time frame: Baseline to Week 26

    Mean change in body mass index (BMI) from baseline to Week 26.

  2. Change in waist circumference

    Time frame: Baseline to Week 26

    Mean change in waist circumference (cm) from baseline to Week 26

  3. Change in blood pressure

    Time frame: Baseline to Week 26

    Mean change in systolic and diastolic blood pressure from baseline to Week 26.

  4. Change in lipid profile

    Time frame: Baseline to Week 26

    Mean change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides from baseline to Week 26

  5. Treatment persistence

    Time frame: Baseline to Week 26

    Proportion of participants persisting on tirzepatide, and time to discontinuation, over 26 weeks.

Other outcomes

  1. Adverse events and serious adverse events

    Time frame: Baseline to Week 26

    Incidence, type, and severity of adverse events and serious adverse events over 26 weeks.

  2. Medication adherence

    Time frame: Baseline to Week 26

    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.

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

    Time frame: Baseline to Week 26

    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.

  4. Change in weight-related quality of life (OWLQOL)

    Time frame: 26 Weeks

    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.

  5. Change in eating behaviour and appetite (EBAQ)

    Time frame: 26 Weeks

    Mean change in the Eating Behaviour and Appetite Questionnaire (EBAQ) score from baseline to Week 26, in the obesity and prediabetes cohorts.

  6. Change in diabetes treatment satisfaction (DTSQs)

    Time frame: Week 26

    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.

  7. Diabetes treatment satisfaction, change version (DTSQc)

    Time frame: Week 30

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Quanita Tayyab, MBBS

CONTACT

[email protected]

+92 331 5119873

Muhammad Daoud Butt, PhD

CONTACT

[email protected]

+60-16-7054015

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

  • BF Biosciences Pvt Ltd

Registry information

Official study 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

Acronym: TRIBUTE-PK

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.