Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients

NCT07728318 | Not Yet Recruiting

• 1 other identifier: Exp141
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline and monthly up to 6 months

Study Arms (2)

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.

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.

Other: Tirzepatide + Standard Therapy (Intervention Group)

Interventions

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'

Tirzepatide + Standard Therapy (Intervention Group)

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

Standard Therapy (Control Group)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akhtar Saeed Medical and Dental College: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Interventions

Tirzepatide; Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: August 12, 2026
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): May 12, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09