Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

Zagazig University150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Non-diabetec Obesity Obesity (Disorder)

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

New Najran General Hospital

Najran, Saudi Arabia

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 12 (3 months) and Week 24 (6 months)

Secondary Outcomes

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

Time frame: 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: %

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.