GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2, PHASE3

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

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, PCOS

Key I/E criterion

•Female

Primary endpoints

•≥5% weight-loss responders•BMI, change•Waist circumference, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06896981

Org study IDNo.BSMMU/2024/12253-5292

Timeline

Milestones

Study start2025-02-01actual

Study first posted2025-03-26actual

Last update posted2025-04-02actual

Primary completion2025-10-31estimated

Study completion2025-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age10 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Other clinical outcomes

MASH / liver

Other (unclassified)

Weight & body composition

4 endpoints

Primary/protocol endpoint

Weight

Time frame:12 weeks

≥5% weight-loss responders

threshold achievement, improvement

Primary/protocol endpoint

Body mass index

Time frame:12 weeks

BMI, change

change from baseline, improvement

Primary/protocol endpoint

Waist circumference

Time frame:12 weeks

Waist circumference, change

change from baseline, improvement

Primary/protocol endpoint

Hip circumference

Time frame:12 weeks

descriptive, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Fasting plasma glucose

Time frame:12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Fasting insulin

Time frame:12 weeks

concentration, descriptive

Primary/protocol endpoint

Homeostasis model assessment of insulin resistance

Time frame:12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Alanine amino transferase

Time frame:12 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

5 endpoints

Primary/protocol endpoint/low confidence

Blood pressure

Time frame:12 weeks

change from baseline, improvement

Primary/protocol endpoint

Total cholesterol

Time frame:12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Primary/protocol endpoint

HDL-cholesterol

Time frame:12 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Primary/protocol endpoint

LDL-cholesterol

Time frame:12 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Primary/protocol endpoint

Triglyceride

Time frame:12 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other clinical outcomes

3 endpoints

Primary/protocol endpoint

Acanthosis nigricans

Time frame:12 weeks

categorical status, improvement

Secondary/protocol endpoint

Total testosterone

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Free androgen index

Time frame:12 weeks

Androgen, change

percent change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Sex hormone binding globulin

Time frame:12 weeks

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.