Prediabetes or OverweightTRIBUTE-PKNCT07809568
Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes
An observational study of Prediabetes or Overweight and Obesity Type 2 Diabetes Mellitus, run by Universiti Sains Malaysia at 9 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes or Overweight, Obesity Type 2 Diabetes Mellitus, Obesity & Overweight
- How many people
- 330 participants
- Where
- 9 sitesPakistan
- Study dates
- 1 Oct 2026to 31 Mar 2028
- How long will I take part?
- 26 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Pakistan9 sites
Capital Development Authority (CDA) Hospital
Islamabad, Punjab Province
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Aga Khan University Hospital (AKUH)
Karachi, Sindh
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Indus Hospital Health Network
Karachi, Sindh
Muhammad Daoud Butt, 03215150497, muhammaddaoud10@yahoo.com
OMI Hospital
Karachi, Sindh
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Jinnah Postgraduate Medical Centre
Lahore, Punjab Province
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Chandka Medical College
Lārkāna, Sindh
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Khyber Medical University
Peshawar, KPK
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Bolan Medical Complex
Quetta, Balouchistan
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
Hanif Medical Complex
Rawalpindi, Punjab Province
Quanita Tayyab, MBBS, +92 331 5119873, quanitatayyab10@gmail.com
About this study
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
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.
Read more
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.
Read the 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.
- Keywords
- Tirzepetide, Type 2 Diabetes, Obesity, Real-world evidence, South Asia, Pakistan
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 26
Secondary outcomes (8)
Change in BMI
Mean change in body mass index (BMI) from baseline to Week 26.
Measured: Baseline to Week 26
Change in waist circumference
Mean change in waist circumference (cm) from baseline to Week 26
Measured: Baseline to Week 26
Change in blood pressure
Mean change in systolic and diastolic blood pressure from baseline to Week 26.
Measured: Baseline to Week 26
Mean change in total cholesterol (mg/dL)
Mean change in total cholesterol from baseline to Week 26.
Measured: Baseline to Week 26
Treatment persistence
Proportion of participants persisting on tirzepatide, and time to discontinuation, over 26 weeks.
Measured: Baseline to Week 26
Mean change in LDL cholesterol (mg/dL)
Mean change in low-density lipoprotein (LDL) cholesterol from baseline to Week 26.
Measured: Baseline to Week 26
Mean change in HDL cholesterol (mg/dL)
Mean change in high-density lipoprotein (HDL) cholesterol from baseline to Week 26.
Measured: Baseline to Week 26
Mean change in triglycerides (mg/dL)
Mean change in triglycerides from baseline to Week 26.
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes or OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
- Target duration
- 26 Weeks
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- BF Biosciences Pvt Ltd
- Responsible party
- Principal investigator, Muhammad Daoud Butt, Universiti Sains Malaysia
- Investigators
- Muhammad Daoud Butt, PhD, Principal investigator, Universiti Sains MalaysiaAbdul Basit, MBBS, Study chair, Indus Hospital Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809568
- Sponsor's protocol ID
- USM_2026_03_029
- Other IDs
- R504-LR-GAL008-2600000333-B158
- Acronym
- TRIBUTE-PK
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07809568
- Acronym / sponsor ID
- TRIBUTE-PK / USM_2026_03_029
- Keywords
- Tirzepetide, Type 2 Diabetes, Obesity, Real-world evidence, South Asia, Pakistan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- BF Biosciences Pvt Ltd
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
8 secondary outcomes
Change in BMI
Time frame: Baseline to Week 26
Change in waist circumference
Time frame: Baseline to Week 26
Change in blood pressure
Time frame: Baseline to Week 26
Mean change in total cholesterol (mg/dL)
Time frame: Baseline to Week 26
Treatment persistence
Time frame: Baseline to Week 26
Mean change in LDL cholesterol (mg/dL)
Time frame: Baseline to Week 26
Mean change in HDL cholesterol (mg/dL)
Time frame: Baseline to Week 26
Mean change in triglycerides (mg/dL)
Time frame: Baseline to Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Daoud Butt, PhD principal investigator
Universiti Sains Malaysia
Abdul Basit, MBBS study chair
Indus Hospital Health Network
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes or Overweight and Obesity Type 2 Diabetes Mellitus, run by Universiti Sains Malaysia at 9 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Quanita Tayyab, MBBS (+92 331 5119873, quanitatayyab10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight (obesity and prediabetes cohorts) (time frame: Baseline to Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.