[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563499":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":33,"responsibleParty":56,"collaborators":60,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":22,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":22,"enrollmentInfo":76,"targetDuration":22,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":91,"whyStopped":22,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Popular Medical College Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Semaglutide","EXPERIMENTAL","This study features a single treatment arm where participants receive semaglutide (Fitaro) for weight management. Administered subcutaneously once weekly, the treatment begins at 0.25 mg and escalates to a maximum of 2.4 mg over 16 weeks based on individual response and tolerance. Participants include overweight or obese adults aged 18 and older, with or without Type 2 Diabetes Mellitus (T2DM). The primary focus is to assess the efficacy and safety of semaglutide in achieving significant weight loss, while also evaluating its impact on metabolic parameters like body mass index (BMI), waist circumference, blood glucose levels, and overall quality of life. Alongside medication, participants will receive lifestyle counseling to encourage dietary adjustments and increased physical activity. Regular follow-up assessments will be conducted to monitor weight loss progress, metabolic health, and any treatment-related adverse events throughout the study duration.",[13],"Drug: Semaglutide Pen",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Semaglutide Pen","In this study, the intervention involves administering semaglutide (Fitaro) to participants for weight management. The treatment protocol includes the following steps:\n\nInitial Dose: Participants will start with a subcutaneous injection of semaglutide at a dose of 0.25 mg once weekly for the first four weeks to allow for tolerance and adjustment.\n\nDose Escalation: After the initial period, the dose will be increased at four-week intervals as follows:\n\nWeek 5: Increase to 0.5 mg Week 9: Increase to 1 mg Week 13: Increase to 1.7 mg Week 17: Increase to a maximum dose of 2.4 mg, if necessary, based on individual weight loss response and tolerability.",[9],[21],"Semaglutide Pen without ADA",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Mohammad Jahid Hasan, MBBS, MPH","CONTACT","+8801767818973","dr.jahid61@gmail.com",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":32},"Tamanna Tabassum, MBBS, MPH","+8801755383138","dr.tabassum1991@gmail.com",[34],{"facility":5,"status":22,"city":35,"state":22,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Dhaka","1000","Bangladesh","BD",{"type":40,"coordinates":41},"Point",[42,43],90.40744,23.7104,{"lat":43,"lon":42},[46,49,53],{"name":47,"role":26,"phone":22,"phoneExt":22,"email":48},"Susmita Zaman, MBBS","dr.susmitazaman@gmail.com",{"name":50,"role":26,"phone":51,"phoneExt":22,"email":52},"Rabiul Awal, BSC","+8801708663914","mdrabiulawal11@gmail.com",{"name":54,"role":55,"phone":22,"phoneExt":22,"email":22},"HAM Nazmul Ahsan","SUB_INVESTIGATOR",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Prof. Dr Quazi Tarikul Islam","Professor, Department of Medicine",[61,64],{"name":62,"class":63},"Pi Research and Development Center, Bangladesh","UNKNOWN",{"name":65,"class":66},"Incepta Pharmaceuticals Ltd","INDUSTRY","100563499","phase-3-efficacy-and-safety-of-semaglutide-for-weight-loss-in-overweight-or-obese-adults-in-bangladesh-with-or-without-type-2-diabetes-mellitus-100563499",false,"NCT06616961","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","Inclusion Criteria:\n\n-Common inclusion criteria for both diabetic and non-diabetic individuals\n\n* Informed consent will be obtained before any trial-related activities\n* Male or female, aged ≥ 18 years at the time of signing the informed consent form\n* Body mass index (BMI) ≥30 kg\u002Fm2 with or without any weight-related comorbidities or ≥25-29.9 kg\u002Fm2 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\n* Patients diagnosed with T2DM more than or equal to 180 days prior to the day of screening.\n* HbA1c up to 12.0%\n\nExclusion Criteria:\n\n* Common exclusion criteria for both diabetic and non-diabetic individuals Medical criteria\n\n  * A self-reported reduction in body weight of more than 5 kg within 30 days before screening, irrespective of medical records\n  * Treatment with any medication for the indication of obesity within the past 90 days before screening (eg. Orlistat, liraglutide, naltrexone\u002Fbupropion, diethylpropion, phendimetrazine, and Setmelanotide etc.)\n  * Any previous obesity treatment with surgery or a weight loss device during lifetime\n  * Continued treatment with other GLP-1 agonists, SGLT-2 inhibitor and\u002For 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.\n  * Patient taking oral or injectable steroid for other indications\n  * Past history of pancreatitis\n  * Diagnosed case of eating disorders eg. Bulimia nervosa\n  * 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\n  * Patients with a personal or family history of medullary thyroid carcinoma (MTC) and\u002For multiple endocrine neoplasia syndrome type 2 (MEN 2)\n  * Known hypersensitivity to Semaglutide or any of the product components.\n  * History of recent MI (within past three months)\n  * Pregnancy and lactation Laboratory criteria\n  * Incidental diagnosis or Uncontrolled thyroid disease, defined as a thyroid stimulating hormone (TSH) level \\> 6.0 mIU\u002FL or \\<0.4 mIU\u002FL as measured by the central laboratory at screening. However, well-controlled thyroid disorder can be included if TSH\\<6.0 or \\>0.4 mIU\u002FL.\n  * Renal impairment, measured as the estimated glomerular filtration rate (eGFR) \\<15 ml\u002Fmin\u002F1.73 m2 For subjects without T2DM\n  * HbA1c more than or equal to 48 mmol\u002Fmol (6.5%) For subjects with T2DM\n  * Renal impairment, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL\u002Fmin\u002F1.73 m2 (less than 60 mL\u002Fmin\u002F1.73 m2 in subjects treated with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)).\n  * Uncontrolled T2DM (HbA1c \\>12.0%) as these patients may require insulin or other anti-diabetic drug which might potentially interfere the efficacy of semaglutide","ALL","18 Years",{"count":77,"type":78},480,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","The goal of this clinical trial is to learn if semaglutide can help with weight loss in overweight or obese adults in Bangladesh. The study will also look at how safe semaglutide is for these participants. The main questions to answers are given below:\n\nDoes semaglutide help participants lose weight after 26 weeks? What changes occur in health measures like blood sugar and quality of life for those taking semaglutide?\n\nParticipants will:\n\nReceive a weekly injection of semaglutide (2.4 mg) for 26 weeks. Follow a plan that includes lifestyle changes, such as diet and physical activity.\n\nHave their body weight, waist size, and blood sugar levels measured regularly. This study aims to provide important information on how well semaglutide works for weight loss in Bangladeshi adults, helping to find effective treatments for obesity in this population.",[84,85],"Obesity","Type 2 Diabetes Mellitus (T2DM)",[9,84,87,85,88,89,90,37],"Overweight","Weight Loss","Efficacy","Safety","NOT_YET_RECRUITING","2024-09-25",{"date":94,"type":95},"2024-09-27","ACTUAL",{"date":97,"type":78},"2024-11-01",{"date":99,"type":78},"2026-10",{"name":5,"class":6},1]