Weekly GLP-1 Receptor Agonists in Obese Individuals Without Diabetes

NCT07834398 | Completed Phase 3

• 1 other identifier: KACST,KSA:H-11-N-140
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 liver functions.

Conditions

Non-diabetec Obesity; Obesity (Disorder)

Keywords

Glucagon-Like Peptide 1 Receptor Agonists; Obesity; Obesity Management Medications

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12 (3 months) and Week 24 (6 months)

Secondary Outcomes (8)

• Change in Body Mass Index (BMI)

  Baseline, 3 months, and 6 months

• Change in Glycated Hemoglobin (HbA1c)

  Baseline, 3 months, and 6 months

• Change in Low-Density Lipoprotein Cholesterol (LDL-C)

  Baseline, 3 months, and 6 months

• Change in Triglycerides

  Baseline, 3 months, and 6 months

• Change in High-Density Lipoprotein Cholesterol (HDL-C)

  Baseline, 3 months, and 6 months

Study Arms (3)

Dulaglutide Group

ACTIVE COMPARATOR

Includes 50 non-diabetic obese participants receiving dulaglutide 1.5 mg subcutaneous once weekly for 24 weeks

Drug: Dulaglutide

Semaglutide Group

ACTIVE COMPARATOR

Includes 50 non-diabetic obese participants receiving semaglutide 2.4 mg subcutaneous once weekly for 24 weeks

Drug: Semagludtide

Tirzepatide Group

ACTIVE COMPARATOR

Includes 50 non-diabetic obese participants receiving Tirzepatide 15 mg subcutaneous once weekly for 24 weeks

Drug: Tirzepatide

Interventions

Dulaglutide DRUG

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

Dulaglutide Group

Semagludtide DRUG

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

Semaglutide Group

Tirzepatide DRUG

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

Tirzepatide Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead
• Najran University: collaborator

Study Sites (1)

New Najran General Hospital

Najran, 55461, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity

Interventions

dulaglutide; Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine, Zagazig University

Model Details: 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

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: September 22, 2026
• Study Start: November 14, 2025
• Primary Completion: April 13, 2026
• Study Completion: April 21, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

SA (1)