GLP-RA , DIABETIC , NON-DIABETIC , BMI ,TYG-index , HDL-C
| Registry | NCT07820111 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 159 (Actual) |
| Sponsor | Zagazig University (Other gov) |
| Conditions | Obese Diabetics, Obese Non Diabetic |
| Interventions | Dulaglutide 1.5 MG/ML, Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution, Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician, Dulaglutide 0.75mg subcutaneous injection, Semaglutide 1.0 mg, Tirzepatide (Flexible titration) (Drug) |
| Dates | start 2025-10-18, primary completion 2026-03-17, completion 2026-03-17, first posted 2026-09-15, last updated 2026-09-15 |
| Locations | 1 site in Saudi Arabia |
Related Papers Related Patents Related Grants Related Experts
All trials for Obese Diabetics All trials for Obese Non Diabetic All trials of Dulaglutide 1.5 MG/ML All trials of Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution
titel : Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial
Abstract :
Background: This study that highlights the different effects of most used three GLP-RA Dulaglutide, Semaglutide, Tirazepetide among diabetic and non -diabetic participant as the well-known fact that they don't have only weight recuing effect but also many different effects on metabolic process including insulin sensitivity, lipid profile and NASH.
Materials and Methods:
This is a randomized controlled study involving a total of 159 participants, divided into 75 non-diabetic and 84 diabetic obese individuals. Participants were assigned to three drug groups, each receiving a once-weekly dose of Dulaglutide, Semaglutide, or Tirzepatide for a period of 24 weeks. Each drug group consisted of 53 individuals, subdivided into 25 non-diabetic and 28 diabetic participants.
Measurements were taken at three time points: pretreatment, 3 months post-treatment, and 6 months post-treatment. Each participant underwent a complete physical exam, and data was collected on weight, BMI, age, and sex and Laboratory tests. , also repeated measurements were taken at 3 and 6 months post-treatment. on metabolic processes, weight reduction, and insulin sensitivity, particularly in diabetic individuals, as well as effects on lipid profiles and liver enzymes, weight reduction, BMI, HbA1c, TYG-index, triglycerides, and HDL-C levels. total cholesterol (Tc) and liver enzymes.
Data were collected, and statistical analyses were conducted afterward.
Methods
Study and population:
This was a randomized controlled clinical trial study conducted at Al-Zafer hospital Najran KSA October 2025. The study received approval from the Institutional Ethics Committee (king Khaled hospital) Najran health cluster KSA on 27 October 2024. IRB registration number with KACST, KSA: H-11-N-136.
Definition of overweight and obesity in adults using Body mass index (BMI): BMI ≥ 25 kg/m² (overweight) and BMI ≥ 30 kg/m² (obesity).
Formula: Body mass index, kg/m2 = weight, kg / (height, m)2 \[24\] Facts \& Figures Simental-Mendia et al. (2008) developed the TyG (Triglyceride-Glucose Index), a mathematical equation that indirectly evaluates IR based on laboratory data: fasting plasma triglycerides and glucose levels \[25\].
Grouping This study was conducted on a total of 159 participants who attend the outpatient internal medicine clinic.
Group 1: included 53 subjects: 25 non-diabetics and 28 diabetics receiving dulaglutide.
Group 2: included 53 subjects: 25 non-diabetics and 28 diabetics receiving semaglutide.
Group 3: included 53 subjects: 25 non-diabetics and 28 diabetics receiving tirzepatide.
The study will be done from October 2025 to March 2026.
Subject included lithe study:
Inclusion criteria: A minimum of 24 weeks of follow-up was required for adults (18-65 years old) who were either overweight or obese, diabetic, or non-diabetic and had received GLP-1RAs.
Exclusion criteria: In a crossover design, GLP-1RA is compared to other drug classes without a placebo arm or using withdrawn medications. Patients who will refuse to be enrolled in the study or refuse to sign the consent will be also excluded.
Method of selection of sample: the sample will be selected by randomized method.
Sample size: Sample size was calculated using G*Power for a mixed-design ANOVA with two between-subject factors (3×2 design) and one within-subject factor (3 repeated measurements). The total sample size was estimated to be 114 participants, with 19 participants in each group, assuming a medium effect size (f = 0.25) for α = 0.05, power = 99%, and a correlation of 0.5 among repeated measures.
All participants underwent:
Full history taking: with special consideration to age, sex, and location of residence and gastrointestinal symptoms, General examination: The body mass index was determined by dividing the weight (in kilograms) by the square of the height (in meters) with particular attention to weight and height. The Centers for Disease Control and Prevention (CDC) classified individuals with a body mass index (BMI) below 18.5 as underweight. Normal is defined as a body mass index (BMI) between 18.5 and 24.9, 25 to 29.9 is considered overweight, and 30 and above is considered obese), Laboratory investigation: includes fasting blood glucose (FBS), lipid profile TC (Total Cholesterol, Triglycerides (TG), LDL (Low Density Cholesterol), HDL (High Density Cholesterol), liver enzymes (ALT, (Alanine Aminotransferase) AST (Aspartate Aminotransferase), HBA1C using device VITROS product chemistry with LDHI slides kits Ortho-clinical Diagnostics USA and Tyg index (insulin resistance).
Data analysis:
Information was entered and evaluated using IBM-SPSS software for Windows, version 27, 2020, developed by IBM SPSS Inc. in Chicago, Illinois, USA. Numerical data are presented as the median (Q1-Q3), while categorical data are expressed as N (%). Comparisons among groups for numerical variables were conducted using the Kruskal-Wallis H-test, and comparisons for categorical variables were made using the Chi-square test. The correlation between two categorical variables was assessed using a 3-way ANOVA test. A binary outcome variable was predicted based on one or more predictors through binary logistic regression analysis. Statistical significance was defined as a p-value less than 0.05, accompanied by a 95% confidence interval.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| obese , non diabetic ,recieve dulaglutide | Active comparator | Drug: Dulaglutide 1.5 MG/ML; Drug: Dulaglutide 0.75mg subcutaneous injection | GLP1-RA |
| obese , non diabetic ,receive SEMAGLUTIDE | Active comparator | Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution; Drug: Semaglutide 1.0 mg | GLP1-RA |
| obese , non diabetic ,receive TIRAZEPETIDE | Active comparator | Drug: Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician; Drug: Tirzepatide (Flexible titration) | GLP1-RA |
| obese , diabetic ,recieve dulaglutide | Active comparator | Drug: Dulaglutide 1.5 MG/ML | GLP1-RA |
| obese , diabetic ,receive SEMAGLUTIDE | Active comparator | Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution; Drug: Semaglutide 1.0 mg | GLP1-RA |
| obese , diabetic ,receive TIRAZEPETIDE | Active comparator | Drug: Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician; Drug: Tirzepatide (Flexible titration) | GLP1-RA |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: * overweight or obese, diabetic, or non-diabetic Exclusion Criteria: * Patients who will refuse to be enrolled in the study or refuse to sign the consent
| Facility | City | Country | Status |
|---|---|---|---|
| Najran Health Cluster | Najran, Ksa | Saudi Arabia |