Semaglutide in Women With Polycystic Ovary Syndrome and Obesity

NCT06896981 | Recruiting Phase 2

• 1 other identifier: No.BSMMU/2024/12253-5292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder that is frequently associated with metabolic features, including obesity. Improvement of metabolic manifestations helps in the control of symptoms, including subfertility. Metformin has been commonly used to decrease insulin resistance and weight in PCOS patients suffering from obesity. Glucagon-like peptide (GLP-1) agonist semaglutide is also effective in managing different metabolic features, including obesity and insulin resistance. There is limited data about using a combination of semaglutide and metformin in women with PCOS suffering from obesity. This study aims to compare the metabolic changes after giving a combination of low-dose semaglutide and metformin vs. metformin alone over 12 weeks among women with PCOS and obesity. This open label randomized trial will be conducted in the Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU). After obtaining informed written consent, a total of 30 patients with PCOS and obesity will be enrolled conveniently (sampling) in the study as per inclusion and exclusion criteria from the outdoor, indoor, and PCOS clinic, Endocrinology, BSMMU. Study participants will be divided into two groups randomly by a computerized random number generator (allocation). One study arm will be treated with low-dose subcutaneous semaglutide (0.25 mg/week for 4 weeks followed by 0.5mg per week for 12 weeks) in combination with metformin (500 mg bid). Another study arm will receive monotherapy with metformin (500 mg bid) for treatment. Both arms will receive standard unified lifestyle advices. Patients will be followed every four weeks for clinical data for up to twelve weeks. Laboratory tests will be done at baseline and the final follow-up in an 8 - 12 hours of fasting state. Two mL of blood will be used to measure glucose using the glucose oxidase method on the same day of sample collection. The remaining three mL of blood will be centrifuged, the serum will be separated and analyzed for insulin, TT, SHBG, ALT and lipid profiles on the same day. All the clinical and biochemical information will be documented in a pretested, semi-structured case record form. Recorded data will be entered, edited, and analyzed by SPSS software version 25.0. Data will be expressed as frequencies \& percentages (%) for qualitative values and mean \& standard deviation (±SD) or median \& inter-quartile range (IQR) for quantitative values depending on their distribution. Kaplan Meier Curve will be used to show the comparison between primary outcomes. For quantitative variables, a comparison between two groups will be done using Mann-Whitney U test, and within a group, a paired t-test or Wilcoxon test will be used. For qualitative variables, a comparison between two groups will be tested using Pearson's chi-square test and within the group by the McNemar test. Regression Analysis will be done to correlate between treatment and outcome. Any p-value below 0.05 will be considered statistically significant. Confidentiality will be strictly maintained. Informed written consent will be taken from patients.

Conditions

Polycystic Ovary Syndrome (PCOS) Women; Obesity

Keywords

Polycystic ovary syndrome; Obesity; Semaglutide; Metformin

Outcome Measures

Primary Outcomes (13)

• Weight

  in Kg, at least 5% weight loss

  12 weeks

• Body mass index

  Kg per meter square

  12 weeks

• Waist circumference

  Centimeter

  12 weeks

• Hip circumference

  Centimeter

  12 weeks

• Blood pressure

  mm of Hg

  12 weeks

• Acanthosis nigricans

  Present or absent

  12 weeks

• Fasting plasma glucose

  mmol/L

  12 weeks

• Fasting insulin

  micro international unit per mL

  12 weeks

• Homeostasis model assessment of insulin resistance

  Using formula provided by Mathew's et al. (1985)

  12 weeks

• Total cholesterol

  mg/dL

  12 weeks

• HDL-cholesterol

  mg/dL

  12 weeks

• LDL-cholesterol

  mg/dL

  12 weeks

• Triglyceride

  mg/dL

  12 weeks

Secondary Outcomes (4)

• Total testosterone

  12 weeks

• Sex hormone binding globulin

  12 weeks

• Free androgen index

  12 weeks

• Alanine amino transferase

  12 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Immediately release metformin 500 mg bd for 12 weeks

Drug: Metformin with Semaglutide

Metformin and semaglutide

EXPERIMENTAL

Immediately release metformin 500 mg bd for 12 weeks and Inj Semaglutide 0.5 mg once weekly for 12 weeks

Drug: Metformin with Semaglutide

Interventions

Metformin with Semaglutide DRUG

One arm: Metformin 500 mg bd, Other arm: Metformin 500 mg bd + Semaglutide 0.5 mg once weekly

Metformin; Metformin and semaglutide

Eligibility Criteria

• Age: 10 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Reproductive-aged women with PCOS diagnosed according to International evidence based guidelines 2023 and obesity

You may not qualify if:

• 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
• Patients having PCOS mimicking endocrine disorders (untreated thyroid dysfunctions, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, acromegaly, hypothalamic disorder etc.)
• Those taking any other weight loss medications (eg., orlistat, liraglutide) within the last 3 months
• Those who have undergone bariatric surgery
• Any conditions causing weight loss (thyrotoxicosis, Addison's disease, chronic infection, connective tissue disorder, cancer, etc)
• Secondary causes of obesity (major mood disorders, steroids, valproate, oral contraceptives, etc)
• Contraindications for semaglutide: personal or family history of medullary carcinoma of the thyroid, history of acute pancreatitis, gallbladder disease
• Planning for pregnancy or current pregnancy/ lactation

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University

Dhaka, Dhaka Division, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Interventions

Metformin; semaglutide

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Muhammad Abul Hasanat, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Abul Hasanat, MD

CONTACT

+880 1711-670735; hasnat_endo@bsmmu.edu.bd

Hurjahan Banu, FCPS

CONTACT

+880 1712-614949; dr.hurjahan_banu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: February 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)