Search / Trial NCT06616961

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

Launched by POPULAR MEDICAL COLLEGE HOSPITAL · Sep 25, 2024

Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Semaglutide Obesity Overweight Type 2 Diabetes Mellitus (T2 Dm) Weight Loss Efficacy Safety Bangladesh

Description

Background and Rationale Obesity has emerged as a significant global health challenge, with its prevalence increasing rapidly across various demographics. Estimates suggest that nearly half of the world\'s population could be classified as overweight by the year 2030. The ramifications of this trend are profound, leading to increased risk for a variety of chronic diseases, including type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, and several cardiovascular diseases. In fact, obesity is estimated to be responsible for approximately five million deaths globally each year, wit...

Gender

ALL

Eligibility criteria

  • 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

About Popular Medical College Hospital

The Popular Medical College Hospital is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence in patient care and medical education, the hospital integrates cutting-edge science with compassionate treatment. Our multidisciplinary team of renowned clinicians and researchers collaborates to conduct rigorous clinical trials across various therapeutic areas, aiming to improve patient outcomes and contribute to the body of medical knowledge. By fostering a culture of inquiry and collaboration, Popular Medical College Hospital is at the forefront of translating scientific discoveries into effective therapies for the community and beyond.

Locations

Dhaka, , Bangladesh

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0