TRIBUTE-PK

Not yet recruiting

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

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

Lead sponsor

Universiti Sains Malaysia

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

330

Study population

Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Eligibility highlights

•BMI ≥30

Primary endpoints

•Body weight•HbA1c

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07809568

Org study IDUSM_2026_03_029

Secondary IDR504-LR-GAL008-2600000333-B158BF Biosciences Private Limited

Timeline

Milestones

Study first posted2026-09-09actual

Study start2026-10-01estimated

Last update posted2026-10-20actual

Primary completion2027-12-28estimated

Study completion2028-03-31estimated

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Obesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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).

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

4 endpoints

Primary/protocol endpoint

Percentage change in body weight (obesity and prediabetes cohorts)

Time frame:Baseline to Week 26

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:Baseline to Week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline to Week 26

change from baseline, improvement

Other/protocol endpoint

Change in weight-related quality of life (OWLQOL)

Time frame:26 Weeks

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in HbA1c (type 2 diabetes cohort)

Time frame:Baseline to Week 26

change from baseline, improvement

Other/protocol endpoint

Change in diabetes treatment satisfaction (DTSQs)

Time frame:Week 26

change from baseline, improvement

Other/protocol endpoint

Diabetes treatment satisfaction, change version (DTSQc)

Time frame:Week 30

descriptive

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in blood pressure

Time frame:Baseline to Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean change in total cholesterol (mg/dL)

Time frame:Baseline to Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean change in LDL cholesterol (mg/dL)

Time frame:Baseline to Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean change in HDL cholesterol (mg/dL)

Time frame:Baseline to Week 26

change from baseline, improvement

Secondary/protocol endpoint

Mean change in triglycerides (mg/dL)

Time frame:Baseline to Week 26

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Other/protocol endpoint

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

Time frame:Baseline to Week 26

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Adverse events and serious adverse events

Time frame:Baseline to Week 26

descriptive

Other clinical outcomes

1 endpoint

Other/protocol endpoint

Medication adherence

Time frame:Baseline to Week 26

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Treatment persistence

Time frame:Baseline to Week 26

descriptive

Other/protocol endpoint/low confidence

Change in eating behaviour and appetite (EBAQ)

Time frame:Baseline to Week 26

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.