Comparison Between the Effects of Low-Dose Semaglutide With Metformin vs. Metformin Alone Over Metabolic Profile in Obese Polycystic Ovary Syndrome: A Phase II Randomized Controlled Trial

Registration

Registration

NCT06896981

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2; PHASE3

Masking

NONE

Status

COMPLETED

Enrollment

31

Start

2025-01-01

Primary completion

2025-10-31

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Conditions

Polycystic Ovary Syndrome (PCOS) Women; Obesity

Interventions

DRUG:Metformin with Semaglutide

Results posted

FALSE

Individual participant data sharing

NO

Registered primary outcomes

• Weight [12 weeks]
• Body mass index [12 weeks]
• Waist circumference [12 weeks]
• Hip circumference [12 weeks]
• Blood pressure [12 weeks]
• Acanthosis nigricans [12 weeks]
• Fasting plasma glucose [12 weeks]
• Fasting insulin [12 weeks]
• Homeostasis model assessment of insulin resistance [12 weeks]
• Total cholesterol [12 weeks]
• HDL-cholesterol [12 weeks]
• LDL-cholesterol [12 weeks]
• Triglyceride [12 weeks]