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Completed

NCT Number: NCT07834398

Weekly GLP-1 Receptor Agonists in 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.

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Key information

Conditions

Non-diabetec Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Disorder) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New Najran General Hospital

Najran, 55461, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects (above 18 years old) obese body mass index (BMI) above 30

Exclusion criteria

  • 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

Treatment and study plan

Dulaglutide

Drug

weight control drug dulaglutide 1.5 mg subcutaneous injection GLP-1 receptor agonist

Semagludtide

Drug

Weight control drug semaglutide 2.4 mg subcutanous injection GLP-1 receptor agonist

Tirzepatide

Drug

Weight control drug tirzepatide 15 mg subcutanous injection GLP-1 receptor agonist

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline, 3 months, and 6 months

    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

  2. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, 3 months, and 6 months

    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: %

  3. Change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline, 3 months, and 6 months

    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

  4. Change in Triglycerides

    Time frame: Baseline, 3 months, and 6 months

    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

  5. Change in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, 3 months, and 6 months

    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

  6. Change in Total Cholesterol (TC)

    Time frame: Baseline, 3 months, and 6 months

    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

  7. Change in Alanine Aminotransferase (ALT)

    Time frame: Baseline, 3 months, and 6 months

    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

  8. Change in Aspartate Aminotransferase (AST)

    Time frame: Baseline, 3 months, and 6 months]

    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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Collaborators

  • Najran University

Registry information

Official study title

Evaluating the Efficacy of Various Weekly GLP1receptor Agonist Among Obese Individuals Without Diabetes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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