Not yet recruitingPhase 3

Efficacy and Safety of Semaglutide for Weight Loss in Overweight or Obese Adults in Bangladesh With or Without Type 2 Diabetes Mellitus

Efficacy and Safety of Semaglutide in Weight Reduction in Overweight or Obese Bangladeshi Adults With or Without Type 2 Diabetes Mellitus

Lead sponsor

Popular Medical College Hospital

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

480

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-29•HbA1c ≤12%

Primary endpoint

•Body weight, absolute change (kg)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06616961

Org study IDNo.BSMMU/2024/7591

Timeline

Milestones

Study first posted2024-09-27actual

Last update posted2024-09-27actual

Study start2024-11-01estimated

Primary completion2025-02estimated (month precision)

Study completion2026-10estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

-Common inclusion criteria for both diabetic and non-diabetic individuals

•Informed consent will be obtained before any trial-related activities

•Male or female, aged ≥ 18 years at the time of signing the informed consent form

•Body mass index (BMI) ≥30 kg/m2 with or without any weight-related comorbidities or ≥25-29.9 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease (more than three months) For subjects with T2DM

•Patients diagnosed with T2DM more than or equal to 180 days prior to the day of screening.

•HbA1c up to 12.0%

Exclusion criteria

•Common exclusion criteria for both diabetic and non-diabetic individuals Medical criteria

-A self-reported reduction in body weight of more than 5 kg within 30 days before screening, irrespective of medical records

-Treatment with any medication for the indication of obesity within the past 90 days before screening (eg. Orlistat, liraglutide, naltrexone/bupropion, diethylpropion, phendimetrazine, and Setmelanotide etc.)

-Any previous obesity treatment with surgery or a weight loss device during lifetime

-Continued treatment with other GLP-1 agonists, SGLT-2 inhibitor and/or metformin. However, if these drugs can be stopped based on the best clinical judgement of the investigator, the patient can be recruited after stopping the drug and a washout period of two weeks. In case of semaglutide (ORSEMA) the wash out period will be 10 weeks.

-Patient taking oral or injectable steroid for other indications

-Past history of pancreatitis

-Diagnosed case of eating disorders eg. Bulimia nervosa

-Patients with a previous history of suicide attempts and major depressive disorder (MDD) according to the DSM-V criteria, schizophrenia or anti-psychotic drug induced obesity

-Patients with a personal or family history of medullary thyroid carcinoma (MTC) and/or multiple endocrine neoplasia syndrome type 2 (MEN 2)

-Known hypersensitivity to Semaglutide or any of the product components.

-History of recent MI (within past three months)

-Pregnancy and lactation Laboratory criteria

-Incidental diagnosis or Uncontrolled thyroid disease, defined as a thyroid stimulating hormone (TSH) level \> 6.0 mIU/L or \<0.4 mIU/L as measured by the central laboratory at screening. However, well-controlled thyroid disorder can be included if TSH\<6.0 or \>0.4 mIU/L.

-Renal impairment, measured as the estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 For subjects without T2DM

-HbA1c more than or equal to 48 mmol/mol (6.5%) For subjects with T2DM

-Renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 (less than 60 mL/min/1.73 m2 in subjects treated with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)).

-Uncontrolled T2DM (HbA1c \>12.0%) as these patients may require insulin or other anti-diabetic drug which might potentially interfere the efficacy of semaglutide

Endpoints (12)

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

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

Body Weight (kg)

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

BMI (kg/m²)

Time frame:26 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference (cm)

Time frame:26 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

HbA1C (%)

Time frame:26 weeks

descriptive, improvement

LOINC 4548-4

Secondary/protocol endpoint

FPG (mmol/l)

Time frame:26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Systolic blood pressure (mmHg)

Time frame:26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic blood pressure (mmHg)

Time frame:26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Total cholesterol (mg/dl)

Time frame:26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Triglyceride

Time frame:26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Quality of Life

Time frame:26 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety endpoints

Time frame:26 weeks

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Dose alteration

Time frame:26 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.