GLP-1 Evidence

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Semaglutide in Women With Polycystic Ovary Syndrome and Obesity

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
NCT06896981 on ClinicalTrials.gov

Status
RecruitingResults none
Why it is watched
non-weight indication: cardiovascular, endocrine, other_emerging
Who it enrolls
age 10 Years to 45 Years; female; no BMI minimum stated; conditions: Polycystic Ovary Syndrome (PCOS) Women; Obesity
Interventions
Metformin with Semaglutide
Conditions
Polycystic Ovary Syndrome (PCOS) Women; Obesity
Phase and size
Phase 2, Phase 3 · 30 participants
Dates
Start 2025-02-01
Primary completion 2025-10-31
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Last checked
Sep 13, 2026
01Endpoints

What the trial will measure

  • Weight12 weeks
  • Body mass index12 weeks
  • Waist circumference12 weeks
  • Hip circumference12 weeks
  • Blood pressure12 weeks
  • Acanthosis nigricans12 weeks
  • Fasting plasma glucose12 weeks
  • Fasting insulin12 weeks
  • Homeostasis model assessment of insulin resistance12 weeks
  • Total cholesterol12 weeks
  • HDL-cholesterol12 weeks
  • LDL-cholesterol12 weeks
  • Triglyceride12 weeks
02Eligibility

Who can take part

Inclusion Criteria: Reproductive-aged women with PCOS diagnosed according to International evidence based guidelines 2023 and obesity Exclusion Criteria: 1. Having DM, other significant systemic diseases- chronic kidney disease (eGFR \<60mL/minute/ 1.73 m2 BSA), chronic liver disease (ALT \>3 × ULN), and heart failure 2. Patients having PCOS mimicking endocrine disorders (untreated thyroid dysfunctions, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, acromegaly, hypothalamic disorder etc.) 3. Those taking any other weight loss medications (eg., orlistat, liraglutide) within the last 3 months 4. Those who have undergone bariatric surgery 5. Any conditions causing weight loss (thyrotoxicosis, Addison's disease, chronic infection, connective tissue disorder, cancer, etc) 6. Secondary causes of obesity (major mood disorders, steroids, valproate, oral contraceptives, etc) 7. Contraindications for semaglutide: personal or family history of medullary carcinoma of the thyroid, history of acute pancreatitis, gallbladder disease 8. Planning for pregnancy or current pregnancy/ lactation
03Change log

Registry changes

No changes recorded since the trial was added.