Type 2 Diabetes Mellitus (T2DM), Obesity, OverweightNCT07728318
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
A study testing Tirzepatide + Standard Therapy (Intervention Group) and Standard Oral Antidiabetic Drugs (OADs) in people with Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, run by Akhtar Saeed Medical and Dental College.
Trial summary
Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disease, often compounded by obesity, that leads to serious long-term health complications. While traditional antidiabetic medications help manage blood sugar, many patients continue to struggle with uncontrolled diabetes and excess weight. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
- What is being tested?
- Tirzepatide + Standard Therapy (Intervention Group) and Standard Oral Antidiabetic Drugs (OADs)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2027to 12 May 2028
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 30 to 80 years with diagnosed Type 2 Diabetes Mellitus.
- Uncontrolled diabetes with HbA1c ≥ 7.0%.
- Obesity defined as Body Mass Index (BMI) ≥ 25 kg/m² (Asian population threshold) or waist circumference > 90 cm in men or > 80 cm in women.
- History of taking oral antidiabetic drugs (OADs) for > 1 year.
Who cannot join
- Patients currently or previously taking GLP-1 receptor agonists or weight loss medications.
- Patients currently receiving insulin therapy.
- Patients taking DPP-4 inhibitors.
- Pregnant or lactating females.
About this study
Official title: Efficacy, Safety and Treatment Satisfaction of Once Weekly Tirzepatide in Obese Type 2 Diabetic Patients at a Tertiary Care Centre
Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disease, often compounded by obesity, that leads to serious long-term health complications. While traditional antidiabetic medications help manage blood sugar, many patients continue to struggle with uncontrolled diabetes and excess weight. Newer therapies, such as dual GIP/GLP-1 receptor agonists like Tirzepatide, have demonstrated significant efficacy in lowering blood glucose (HbA1c) and body weight in global clinical trials. However, real-world data regarding its efficacy, safety, and patient-reported satisfaction in South Asian populations, particularly in Pakistan, remains limited. This 6-month, quasi-experimental interventional study aims to compare the clinical outcomes and patient-reported satisfaction of once-weekly subcutaneous Tirzepatide (combined with standard oral antidiabetic therapy) versus standard therapy alone in obese patients with Type 2 Diabetes. A total of 52 eligible participants will be randomly allocated into two groups. Group 1 will receive standard oral antidiabetic treatment, while Group 2 will receive once-weekly Tirzepatide with dose escalation (starting at 2.5 mg monthly, increasing to 5 mg, and maintaining at 7.5 mg) alongside standard treatment. Primary evaluations will measure changes in HbA1c and body weight from baseline to 6 months. Secondary objectives include monitoring the frequency and severity of gastrointestinal side effects fortnightly and evaluating patient treatment satisfaction at 6 months using the validated Diabetes Treatment Satisfaction Questionnaire (DTSQ).
- Being tested
- Tirzepatide + Standard Therapy (Intervention Group), Standard Oral Antidiabetic Drugs (OADs)
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirzepatide + Standard Therapy (Intervention Group)Other
Administered subcutaneously once weekly with dose escalation:
Month 1: 2.5 mg once weekly Month 2: 5 mg once weekly Months 3 to 6: Maintenance dose of 7.5 mg once weekly'
Standard Oral Antidiabetic Drugs (OADs)Other
Standard oral antidiabetic therapy including Metformin (500mg, 1000mg, or 1500mg daily) with or without SGLT2 inhibitors (Dapagliflozin or Empagliflozin) maintained throughout the 6-month study period
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy (Control Group) | Active comparator | Participants will continue their baseline standard oral antidiabetic drug (OAD) therapy (metformin with or without SGLT2 inhibitors like dapagliflozin or empagliflozin) for 6 months . All participants will also receive monthly dietary counseling from a nutritionist and a recommended walking regimen of 30 minutes, 5 days a week. Receives: Other: Standard Oral Antidiabetic Drugs (OADs) |
| Tirzepatide + Standard Therapy (Intervention Group) | Experimental | Participants will receive subcutaneous once-weekly Tirzepatide added to their baseline standard oral antidiabetic drug (OAD) therapy for 6 months . Tirzepatide will be initiated at 2.5 mg once weekly for Month 1, escalated to 5 mg once weekly for Month 2, and maintained at 7.5 mg once weekly for Months 3-6 . Participants will also receive monthly dietary counseling and a recommended walking regimen. Receives: Other: Tirzepatide + Standard Therapy (Intervention Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Control (HbA1c)
Mean change in HbA1c percentage from baseline to evaluate efficacy in glycemic control (a reduction of ≥1% is defined as clinically effective).
Measured: Baseline, 3 months, and 6 months
Change in Body Weight
Mean percentage change in body weight from baseline (a weight reduction of ≥5% is defined as clinically effective).
Measured: Baseline and monthly up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start12 Dec 2027 (estimated)
- Primary completion12 Jan 2028 (estimated)
- Study completion12 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM), Obesity, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akhtar Saeed Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shameen Hashmi, Akhtar Saeed Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728318
- Sponsor's protocol ID
- Exp141
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Treatment Satisfaction of Once Weekly Tirzepatide in Obese Type 2 Diabetic Patients at a Tertiary Care Centre
- ClinicalTrials.gov ID
- NCT07728318
- Acronym / sponsor ID
- Exp141
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Akhtar Saeed Medical and Dental CollegeUniversity, hospital or other
- Study start
- 12 Dec 2027 (estimated)
- Primary completion
- 12 Jan 2028 (estimated)
- Study completion
- 12 May 2028 (estimated)
- First posted
- 27 Jul 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.
Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disease, often compounded by obesity, that leads to serious long-term health complications. While traditional antidiabetic medications help manage blood sugar, many patients continue to struggle with uncontrolled diabetes and excess weight. Newer therapies, such as dual GIP/GLP-1 receptor agonists like Tirzepatide, have demonstrated significant efficacy in lowering blood glucose (HbA1c) and body weight in global clinical trials. However, real-world data regarding its efficacy, safety, and patient-reported satisfaction in South Asian populations, particularly in Pakistan, remains limited. This 6-month, quasi-experimental interventional study aims to compare the clinical outcomes and patient-reported satisfaction of once-weekly subcutaneous Tirzepatide (combined with standard oral antidiabetic therapy) versus standard therapy alone in obese patients with Type 2 Diabetes. A total of 52 eligible participants will be randomly allocated into two groups. Group 1 will receive standard oral antidiabetic treatment, while Group 2 will receive once-weekly Tirzepatide with dose escalation (starting at 2.5 mg monthly, increasing to 5 mg, and maintaining at 7.5 mg) alongside standard treatment. Primary evaluations will measure changes in HbA1c and body weight from baseline to 6 months. Secondary objectives include monitoring the frequency and severity of gastrointestinal side effects fortnightly and evaluating patient treatment satisfaction at 6 months using the validated Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy (Control Group) | Active comparator | Other: Standard Oral Antidiabetic Drugs (OADs)Participants will continue their baseline standard oral antidiabetic drug (OAD) therapy (metformin with or without SGLT2 inhibitors like dapagliflozin or empagliflozin) for 6 months . All participants will also receive monthly dietary counseling from a nutritionist and a recommended walking regimen of 30 minutes, 5 days a week. |
| Tirzepatide + Standard Therapy (Intervention Group) | Experimental | Other: Tirzepatide + Standard Therapy (Intervention Group)Participants will receive subcutaneous once-weekly Tirzepatide added to their baseline standard oral antidiabetic drug (OAD) therapy for 6 months . Tirzepatide will be initiated at 2.5 mg once weekly for Month 1, escalated to 5 mg once weekly for Month 2, and maintained at 7.5 mg once weekly for Months 3-6 . Participants will also receive monthly dietary counseling and a recommended walking regimen. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged 30 to 80 years with diagnosed Type 2 Diabetes Mellitus.
- Uncontrolled diabetes with HbA1c ≥ 7.0%.
- Obesity defined as Body Mass Index (BMI) ≥ 25 kg/m² (Asian population threshold) or waist circumference > 90 cm in men or > 80 cm in women.
- History of taking oral antidiabetic drugs (OADs) for > 1 year.
Key exclusion criteria (4 listed)
- Patients currently or previously taking GLP-1 receptor agonists or weight loss medications.
- Patients currently receiving insulin therapy.
- Patients taking DPP-4 inhibitors.
- Pregnant or lactating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirzepatide + Standard Therapy (Intervention Group)Administered subcutaneously once weekly with dose escalation: Month 1: 2.5 mg once weekly Month 2: 5 mg once weekly Months 3 to 6: Maintenance dose of 7.5 mg once weekly' | Other | Tirzepatide + Standard Therapy (Intervention Group) |
| Standard Oral Antidiabetic Drugs (OADs)Standard oral antidiabetic therapy including Metformin (500mg, 1000mg, or 1500mg daily) with or without SGLT2 inhibitors (Dapagliflozin or Empagliflozin) maintained throughout the 6-month study period | Other | Standard Therapy (Control Group) |
Primary outcome
Change in Glycemic Control (HbA1c)
Time frame: Baseline, 3 months, and 6 months
Mean change in HbA1c percentage from baseline to evaluate efficacy in glycemic control (a reduction of ≥1% is defined as clinically effective).
Change in Body Weight
Time frame: Baseline and monthly up to 6 months
Mean percentage change in body weight from baseline (a weight reduction of ≥5% is defined as clinically effective).
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 29 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tirzepatide + Standard Therapy (Intervention Group) and Standard Oral Antidiabetic Drugs (OADs) in people with Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, run by Akhtar Saeed Medical and Dental College.
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 4 inclusion and 4 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycemic Control (HbA1c) (time frame: Baseline, 3 months, and 6 months). 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 29 Oct 2026.