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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

NCT ID NCT07809568

NEW Sponsor: Universiti Sains Malaysia Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity & overweight Obesity type 2 diabetes mellitus Prediabetes or overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aga Khan University Hospital (AKUH)

    Karachi, Sindh, Pakistan

  • Bolan Medical Complex

    Quetta, Balouchistan, Pakistan

  • Capital Development Authority (CDA) Hospital

    Islamabad, Punjab Province, Pakistan

  • Chandka Medical College

    Lārkāna, Sindh, Pakistan

  • Hanif Medical Complex

    Rawalpindi, Punjab Province, Pakistan

  • Indus Hospital Health Network

    Karachi, Sindh, Pakistan

  • Jinnah Postgraduate Medical Centre

    Lahore, Punjab Province, Pakistan

  • Khyber Medical University

    Peshawar, KPK, Pakistan

  • OMI Hospital

    Karachi, Sindh, Pakistan

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