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

Plain-language guide to NCT07728318: not phased non-randomized trial of Tirzepatide, 52 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07728318
Phase
not phased
Status
not yet recruiting
Start
2026-08-12
Completion (planned or actual)
2027-01-12
Participants
52 (estimated)
Design
non-randomized, open label (everyone knows who gets what), treatment
Conditions studied
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Tirzepatide.

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.

It had two arms (groups): Standard Therapy (Control Group) (active comparator) and Tirzepatide + Standard Therapy (Intervention Group) (experimental).

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.

The registry classes the interventions as other.

Who Took Part

Enrollment: 52 planned participants were the target.

It was open to people of any sex aged from 30 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female patients aged 30 to 80 years with diagnosed Type 2 Diabetes Mellitus. 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients currently or previously taking glp-1 receptor agonists or weight loss medications; patients currently receiving insulin therapy; patients taking dpp-4 inhibitors.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2026-08-12 with completion listed for 2027-01-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycemic Control (HbA1c) (time frame: Baseline, 3 months, and 6 months). Change in Body Weight (time frame: Baseline and monthly up to 6 months).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Tirzepatide in 52 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.