Obese DiabeticsPhase 3NCT07820111
Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial
A Phase 3 study testing Dulaglutide 1.5 MG/ML, Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution and 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 in people with Obese Diabetics and Obese Non Diabetic, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese Diabetics, Obese Non Diabetic
- What is being tested?
- Dulaglutide 1.5 MG/ML, Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution and 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Oct 2025to 17 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight or obese, diabetic, or non-diabetic
Who cannot join
- Patients who will refuse to be enrolled in the study or refuse to sign the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GLP-RA , DIABETIC , NON-DIABETIC , BMI ,TYG-index , HDL-C
titel : Comparative Study of Different Weekly GLP-1 Receptor Agonists Among Diabetic and Non-Diabetic Patients: Clinical Trial
Abstract :
Read more
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.
Read the detailed description
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.
- Conditions
- Obese Diabetics, Obese Non Diabetic
- Being tested
- 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
- Keywords
- GLP1-RA, Type 2 Diabetes Mellitus (T2DM), Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulaglutide 1.5 MG/MLDrug
once weekly dulaglutide injection
Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solutionDrug
once weekly
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 physicianDrug
once weekly tirzeptide 7.5 and 15 mg
Dulaglutide 0.75mg subcutaneous injectionDrug
once weekly
Semaglutide 1.0 mgDrug
once weekly
Tirzepatide (Flexible titration)Drug
once weekly
| Study group | Role | What they receive |
|---|---|---|
| obese , non diabetic ,recieve dulaglutide | Active comparator | GLP1-RA Receives: Drug: Dulaglutide 1.5 MG/ML; Drug: Dulaglutide 0.75mg subcutaneous injection |
| obese , non diabetic ,receive SEMAGLUTIDE | Active comparator | GLP1-RA Receives: Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution; Drug: Semaglutide 1.0 mg |
| obese , non diabetic ,receive TIRAZEPETIDE | Active comparator | GLP1-RA Receives: 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) |
| obese , diabetic ,recieve dulaglutide | Active comparator | GLP1-RA Receives: Drug: Dulaglutide 1.5 MG/ML |
| obese , diabetic ,receive SEMAGLUTIDE | Active comparator | GLP1-RA Receives: Drug: Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution; Drug: Semaglutide 1.0 mg |
| obese , diabetic ,receive TIRAZEPETIDE | Active comparator | GLP1-RA Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight at 3 and 6 months
Change from baseline in body weight (kg) at 3 and 6 months among diabetic and non-diabetic participants receiving weekly GLP-1 receptor agonists.
Measured: 6-MONTH STUDY PERIOD
Secondary outcomes (8)
Change in Body Mass Index (BMI)
Change in BMI from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: kg/m²
Measured: 3 months, and 6 months
Change in Glycated Hemoglobin (HbA1c)
Change in HbA1c from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: %
Measured: Baseline, 3 months, and 6 months
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Change in LDL-C from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: mg/dL
Measured: Baseline, 3 months, and 6 months
Change in Triglycerides
Change in serum triglyceride concentration from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: mg/dL
Measured: Baseline, 3 months, and 6 months
Change in Alanine Aminotransferase (ALT)
Change in serum ALT concentration from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: U/L
Measured: Baseline, 3 months, and 6 months
Change in Aspartate Aminotransferase (AST)
Change in serum AST concentration from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: U/L
Measured: Baseline, 3 months, and 6 months
Change in High-Density Lipoprotein Cholesterol (HDL-C)
Change in HDL-C from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: mg/dL
Measured: Baseline, 3 months, and 6 months
Change in Total Cholesterol (TC)
Change in TC from baseline to 3 months and 6 months among participants receiving GLP-1 receptor agonists, analyzed separately in diabetic and non-diabetic participants.
Unit of Measure: mg/dL
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start18 Oct 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese DiabeticsStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Osama Ibraheem husini Moustafa, Zagazig University
- Investigators
- hany moustafa ibraheem, ph-d, Principal investigator, alzafer hospital , najran , KSAosama ibraheem Moustafa, ph-d, Study director, najran health cluster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820111
- Sponsor's protocol ID
- KACST,KSA:H-11-N-136
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including demographic characteristics, baseline clinical characteristics, anthropometric measurements, laboratory results, treatment assignment, adherence data, and outcome measures collected during the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-RA , DIABETIC , NON-DIABETIC , BMI ,TYG-index , HDL-C
- ClinicalTrials.gov ID
- NCT07820111
- Acronym / sponsor ID
- KACST,KSA:H-11-N-136
- Conditions
- Obese Diabetics, Obese Non Diabetic
- Keywords
- GLP1-RA, Type 2 Diabetes Mellitus (T2DM), Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 18 Oct 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 15 Sep 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| obese , non diabetic ,recieve dulaglutide | Active comparator | Drug: Dulaglutide 1.5 MG/ML, Drug: Dulaglutide 0.75mg subcutaneous injectionGLP1-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 mgGLP1-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/MLGLP1-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 mgGLP1-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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- overweight or obese, diabetic, or non-diabetic
Key exclusion criteria (1 listed)
- Patients who will refuse to be enrolled in the study or refuse to sign the consent
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 |
|---|---|---|
| Dulaglutide 1.5 MG/MLonce weekly dulaglutide injection | Drug | obese , diabetic ,recieve dulaglutide, obese , non diabetic ,recieve dulaglutide |
| Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solutiononce weekly | Drug | obese , diabetic ,receive SEMAGLUTIDE, obese , non diabetic ,receive SEMAGLUTIDE |
| 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 physicianonce weekly tirzeptide 7.5 and 15 mg | Drug | obese , diabetic ,receive TIRAZEPETIDE, obese , non diabetic ,receive TIRAZEPETIDE |
| Dulaglutide 0.75mg subcutaneous injectiononce weekly | Drug | obese , non diabetic ,recieve dulaglutide |
| Semaglutide 1.0 mgonce weekly | Drug | obese , diabetic ,receive SEMAGLUTIDE, obese , non diabetic ,receive SEMAGLUTIDE |
| Tirzepatide (Flexible titration)once weekly | Drug | obese , diabetic ,receive TIRAZEPETIDE, obese , non diabetic ,receive TIRAZEPETIDE |
Primary outcome
change in body weight at 3 and 6 months
Time frame: 6-MONTH STUDY PERIOD
Change from baseline in body weight (kg) at 3 and 6 months among diabetic and non-diabetic participants receiving weekly GLP-1 receptor agonists.
8 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: 3 months, and 6 months
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 3 months, and 6 months
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, 3 months, and 6 months
Change in Triglycerides
Time frame: Baseline, 3 months, and 6 months
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline, 3 months, and 6 months
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline, 3 months, and 6 months
Change in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, 3 months, and 6 months
Change in Total Cholesterol (TC)
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including demographic characteristics, baseline clinical characteristics, anthropometric measurements, laboratory results, treatment assignment, adherence data, and outcome measures collected during the study.
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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. This study is not recruiting at the moment.
hany moustafa ibraheem, ph-d principal investigator
alzafer hospital , najran , KSA
osama ibraheem Moustafa, ph-d study director
najran health cluster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dulaglutide 1.5 MG/ML, Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution and 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 in people with Obese Diabetics and Obese Non Diabetic, run by Zagazig University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 body weight at 3 and 6 months (time frame: 6-MONTH STUDY PERIOD). 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 15 Sep 2026.