Non-diabetec ObesityPhase 3NCT07834398
Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes
A Phase 3 study testing Dulaglutide, Semagludtide and Tirzepatide in people with Non-diabetec Obesity and Obesity (Disorder), run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
This randomized controlled trial evaluates the efficacy of three weekly GLP-1 receptor agonists (dulaglutide, semaglutide, and tirzepatide) in non-diabetic obese adults. 150 participants with BMI >30 will be randomized into three groups and followed for 6 months to assess changes in weight, BMI, lipid profile, and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-diabetec Obesity, Obesity (Disorder)
- What is being tested?
- Dulaglutide, Semagludtide and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 Nov 2025to 21 Apr 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
- Subjects (above 18 years old) obese body mass index (BMI) above 30
Who cannot join
- Subjects with liver disease, renal dysfunction diabetes, pancreatic diseases ,thyroid disorder or goiter psychological diseases like depression and pregnant women, and Patients who will refuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Various Weekly GLP1receptor Agonist Among Obese Individuals Without Diabetes
This randomized controlled trial evaluates the efficacy of three weekly GLP-1 receptor agonists (dulaglutide, semaglutide, and tirzepatide) in non-diabetic obese adults. 150 participants with BMI >30 will be randomized into three groups and followed for 6 months to assess changes in weight, BMI, lipid profile, and liver functions.
Read the detailed description
This is a single-center, randomized controlled trial planned at Al-Zafer Hospital, Najran, KSA.
150 non-diabetic obese participants (BMI >30, age >18) will be randomized into three equal groups: Group 1: Dulaglutide 1.5 mg weekly Group 2: Semaglutide 1.0 mg weekly Group 3: Tirzepatide 5 mg weekly, titrated as tolerated
Participants will be assessed at baseline, 3 months, and 6 months for weight, BMI, waist circumference, fasting glucose, lipid profile, and liver enzymes. Monthly follow-up will ensure medication adherence and monitor gastrointestinal adverse events.
Inclusion: BMI >30, age >18, non-diabetic. Exclusion: Diabetes, liver disease, renal dysfunction, pancreatic disease, thyroid disease, psychological disorders, pregnancy.
- Conditions
- Non-diabetec Obesity, Obesity (Disorder)
- Being tested
- Dulaglutide, Semagludtide, Tirzepatide
- Keywords
- Glucagon-Like Peptide 1 Receptor Agonists, Obesity, Obesity Management Medications
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
weight control drug dulaglutide 1.5 mg subcutaneous injection GLP-1 receptor agonist
SemagludtideDrug
Weight control drug semaglutide 2.4 mg subcutanous injection GLP-1 receptor agonist
TirzepatideDrug
Weight control drug tirzepatide 15 mg subcutanous injection GLP-1 receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide Group | Active comparator | Includes 50 non-diabetic obese participants receiving dulaglutide 1.5 mg subcutaneous once weekly for 24 weeks Receives: Drug: Dulaglutide |
| Semaglutide Group | Active comparator | Includes 50 non-diabetic obese participants receiving semaglutide 2.4 mg subcutaneous once weekly for 24 weeks Receives: Drug: Semagludtide |
| Tirzepatide Group | Active comparator | Includes 50 non-diabetic obese participants receiving Tirzepatide 15 mg subcutaneous once weekly for 24 weeks Receives: Drug: Tirzepatide |
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 analyzed separately among obese non-diabetic participants receiving weekly GLP-1 receptor agonists.
Measured: Baseline, Week 12 (3 months) and Week 24 (6 months)
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 obese non-diabetic participants.
Unit of Measure: kg/m²
Measured: Baseline, 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 obese 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 obese 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 obese non-diabetic participants.
Unit of Measure: mg/dL
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 obese 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 obese 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 obese 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 obese non-diabetic participants.
Unit of Measure: U/L
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 posted22 Sep 2026
- Study start14 Nov 2025
- Primary completion13 Apr 2026
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-diabetec ObesityStudies 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
- Model description
- Site of study: the study will be conducted in single center (Alzafer) hospital Najran KSA. The sample size: 150 person. Subjects included in the study will be divided into 3 groups: Group 1: include 50 non-diabetec obese subjects receiving dulaglutide Group 2: include 50 non-diabetec obese subjects receiving semaglutide Group 3: include 50 non-diabetec obese subjects receiving tirzepatide The study will be done in November 2025 to April 2026
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Najran University
- Responsible party
- Principal investigator, Osama Ibraheem husini Moustafa, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834398
- Sponsor's protocol ID
- KACST,KSA:H-11-N-140
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Various Weekly GLP1receptor Agonist Among Obese Individuals Without Diabetes
- ClinicalTrials.gov ID
- NCT07834398
- Acronym / sponsor ID
- KACST,KSA:H-11-N-140
- Conditions
- Non-diabetec Obesity, Obesity (Disorder)
- Keywords
- Glucagon-Like Peptide 1 Receptor Agonists, Obesity, Obesity Management Medications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Najran University
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 22 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.
This randomized controlled trial evaluates the efficacy of three weekly GLP-1 receptor agonists (dulaglutide, semaglutide, and tirzepatide) in non-diabetic obese adults. 150 participants with BMI >30 will be randomized into three groups and followed for 6 months to assess changes in weight, BMI, lipid profile, and liver functions.
Detailed description
This is a single-center, randomized controlled trial planned at Al-Zafer Hospital, Najran, KSA.
150 non-diabetic obese participants (BMI >30, age >18) will be randomized into three equal groups: Group 1: Dulaglutide 1.5 mg weekly Group 2: Semaglutide 1.0 mg weekly Group 3: Tirzepatide 5 mg weekly, titrated as tolerated
Participants will be assessed at baseline, 3 months, and 6 months for weight, BMI, waist circumference, fasting glucose, lipid profile, and liver enzymes. Monthly follow-up will ensure medication adherence and monitor gastrointestinal adverse events.
Inclusion: BMI >30, age >18, non-diabetic. Exclusion: Diabetes, liver disease, renal dysfunction, pancreatic disease, thyroid disease, psychological disorders, pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Site of study: the study will be conducted in single center (Alzafer) hospital Najran KSA. The sample size: 150 person. Subjects included in the study will be divided into 3 groups: Group 1: include 50 non-diabetec obese subjects receiving dulaglutide Group 2: include 50 non-diabetec obese subjects receiving semaglutide Group 3: include 50 non-diabetec obese subjects receiving tirzepatide The study will be done in November 2025 to April 2026
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide Group | Active comparator | Drug: DulaglutideIncludes 50 non-diabetic obese participants receiving dulaglutide 1.5 mg subcutaneous once weekly for 24 weeks |
| Semaglutide Group | Active comparator | Drug: SemagludtideIncludes 50 non-diabetic obese participants receiving semaglutide 2.4 mg subcutaneous once weekly for 24 weeks |
| Tirzepatide Group | Active comparator | Drug: TirzepatideIncludes 50 non-diabetic obese participants receiving Tirzepatide 15 mg subcutaneous once weekly for 24 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects (above 18 years old) obese body mass index (BMI) above 30
Key exclusion criteria (1 listed)
- Subjects with liver disease, renal dysfunction diabetes, pancreatic diseases ,thyroid disorder or goiter psychological diseases like depression and pregnant women, and Patients who will refuse
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 |
|---|---|---|
| Dulaglutideweight control drug dulaglutide 1.5 mg subcutaneous injection GLP-1 receptor agonist | Drug | Dulaglutide Group |
| SemagludtideWeight control drug semaglutide 2.4 mg subcutanous injection GLP-1 receptor agonist | Drug | Semaglutide Group |
| TirzepatideWeight control drug tirzepatide 15 mg subcutanous injection GLP-1 receptor agonist | Drug | Tirzepatide Group |
Primary outcome
change in body weight at 3 and 6 months
Time frame: Baseline, Week 12 (3 months) and Week 24 (6 months)
Change from baseline in body weight (kg) at 3 and 6 months analyzed separately among obese non-diabetic participants receiving weekly GLP-1 receptor agonists.
8 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline, 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 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
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]
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
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, Semagludtide and Tirzepatide in people with Non-diabetec Obesity and Obesity (Disorder), 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 22 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: Baseline, Week 12 (3 months) and Week 24 (6 months)). 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 22 Sep 2026.