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Clinical Trial Details

Trial ID: L6427
Source ID: NCT06616961
Associated Drug: Semaglutide Pen
Title: Efficacy and Safety of Semaglutide for Weight Loss in Overweight or Obese Adults in Bangladesh With or Without Type 2 Diabetes Mellitus
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Obesity|Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Semaglutide Pen
Outcome Measures: Primary: Body Weight (kg), Measured at baseline (week 0) and at week 26, with specific targets for weight loss of 5%, 10%, 15%, and 20%., 26 weeks | Secondary: BMI (kg/m²), Body Mass Index (BMI) is calculated using the formula: BMI=weight (kg)/height (m)2, 26 weeks|Waist circumference (cm), Waist circumference measures the size of a person\'s waist and indicates body fat distribution. To measure, find the natural waistline above the belly button, wrap a flexible measuring tape around it, and record the measurement., 26 weeks|HbA1C (%), HbA1c, or glycated hemoglobin, measures average blood sugar levels over the past 3 months., 26 weeks|FPG (mmol/l), Fasting blood glucose, 26 weeks|Systolic blood pressure (mmHg), Systolic Blood Pressure (SBP) is the pressure in your arteries when your heart beats, representing the maximum pressure during heart contraction. It is the higher number in a blood pressure reading, such as 120 in 120/80 mmHg, 26 weeks|Diastolic blood pressure (mmHg), Diastolic pressure is the lower number in a blood pressure reading, indicating the pressure in the arteries when the heart is at rest between beats. It reflects the minimum pressure in the arteries and is important for assessing cardiovascular health., 26 weeks|Total cholesterol (mg/dl), Total cholesterol is a measure of the combined levels of cholesterol in your blood, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), and very low-density lipoprotein (VLDL). It is an important indicator of heart health, as high levels can increase the risk of heart disease and stroke. Total cholesterol levels are usually measured in milligrams per deciliter (mg/dL)., 26 weeks|Triglyceride, Triglycerides are a type of fat (lipid) found in your blood. They are used by the body for energy and are stored in fat cells. High levels of triglycerides can increase the risk of heart disease, especially when combined with low HDL (good cholesterol) or high LDL (bad cholesterol). Triglyceride levels are typically measured in milligrams per deciliter (mg/dL)., 26 weeks|Dose alteration, Change or increment of hypoglycemic agents in patients with T2DM Reduction or increment of antihypertensive drugs in patients with hypertension, 26 weeks|Quality of Life, The Obesity-specific Quality of Life instrument (OSQOL) evaluates four key domains: physical state, vitality, social interactions, and psychological state. This assessment is conducted over a 26-week period to gauge changes in quality of life specific to individuals with obesity. When reporting scores, it\'s essential to include the full scale title, along with the minimum and maximum values. For clarity, specify whether higher scores indicate a better or worse outcome, ensuring that the results provide meaningful insights into the participants\' quality of life., 26 weeks|Safety endpoints, Adverse Events: Number of treatment-related adverse events from baseline to week 26. Serious Adverse Events (SAEs): Number of SAEs from baseline to week 26., 26 weeks
Sponsor/Collaborators: Sponsor: Popular Medical College Hospital | Collaborators: Pi Research and Development Center, Bangladesh|Incepta Pharmaceuticals Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 480
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-10
Results First Posted:
Last Update Posted: 2024-09-27
Locations: Popular Medical College Hospital, Dhaka, 1000, Bangladesh
URL: https://clinicaltrials.gov/show/NCT06616961