Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616961
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Efficacy and Safety of Semaglutide for Weight Loss in Overweight or Obese Adults in Bangladesh With or Without Type 2 Diabetes Mellitus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Semaglutide in Weight Reduction in Overweight or Obese Bangladeshi Adults With or Without Type 2 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Does 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
Participants will
Receive a weekly injection of semaglutide 24 mg for 26 weeks Follow a plan that includes lifestyle changes such as diet and physical activity
Have 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
Does 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
Participants will
Receive a weekly injection of semaglutide 24 mg for 26 weeks Follow a plan that includes lifestyle changes such as diet and physical activity
Have 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
Detailed 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 world39s 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 with a notable mortality rate of 626 deaths per 100000 individuals suffering from obesity Although the mortality rates in low- and middle-income countries are lower than in developed regions trends indicate a concerning increase in obesity-related mortality in these areas
Even modest weight loss 5-10 of body weight can lead to significant health benefits such as slowing the progression of T2DM and reducing cardiovascular risks Moreover evidence indicates that weight reduction can correlate with an 18 reduction in premature mortality Traditional weight management strategies primarily involve lifestyle modifications such as dietary changes and increased physical activity however many individuals find it difficult to achieve and sustain these changes
While surgical options are available for severe cases of obesity they come with inherent risks and complications that necessitate ongoing follow-up care In this context pharmacotherapy offers a valuable adjunct to lifestyle interventions helping individuals achieve and maintain clinically relevant weight loss while potentially improving coexisting health conditions
Currently there are limited anti-obesity medications available thus there is a pressing need for more effective therapeutic options that can aid in weight maintenance and comorbidity prevention Among the medications approved for long-term use is semaglutide a glucagon-like peptide-1 receptor agonist initially developed for the treatment of T2DM Recent studies have demonstrated its effectiveness in promoting weight loss particularly in Caucasian populations
However existing trials primarily include participants from Europe and North America This raises questions about the applicability of these findings in Asian populations such as those in Bangladesh where genetic and environmental factors can influence obesity outcomes significantly Morphological differences exist between populations for instance central obesity is more prevalent among Caucasians while subcutaneous fat accumulation is common in Asians
In Bangladesh semaglutide Fitaro is available for weight management at various doses 025 mg to 24 mg but there is a lack of specific evidence regarding its efficacy and safety in this demographic This study aims to fill that gap by investigating the effectiveness of semaglutide in overweight or obese individuals with or without T2DM within the Bangladeshi population
Study Objectives and Hypothesis Research Question
What is the role of semaglutide in managing obesity and overweight among the Bangladeshi population Hypotheses
Null Hypothesis Semaglutide is not effective in managing obesity and overweight among the Bangladeshi population
Alternative Hypothesis Semaglutide is effective in managing obesity and overweight among the Bangladeshi population
Objectives
Primary Objective
To assess the efficacy and safety of semaglutide administered once weekly for weight loss in overweight or obese patients with or without T2DM
Secondary Objectives
To evaluate the efficacy and safety of semaglutide for weight reduction in overweight or obese individuals without T2DM
To investigate the efficacy and safety of semaglutide for weight reduction in overweight or obese individuals with T2DM
To compare the efficacy and safety profiles of semaglutide between diabetic and non-diabetic obese patients
To examine the effects of semaglutide on metabolic conditions associated with T2DM hypertension dyslipidemia and hyperuricemia
To assess the impact of semaglutide on quality of life in overweight or obese patients
Methodology Study Design This study will be a single-arm experimental trial conducted in real-world settings across multiple hospitals in Bangladesh including Popular Medical College Hospital Dhaka Medical College Hospital Bangabandhu Sheikh Mujib Medical University and others
Study Population Participants will be grouped into two categories Group A Overweight or obese patients without T2DM Group B Overweight or obese patients with T2DM Sample Size Using OpenEpi software with a significance level set at 95 and a power of 90 we estimate needing a total sample size of approximately 480 participants 240 per group to account for a potential dropout rate of 20
Inclusion Criteria Both diabetic and non-diabetic participants -
Must provide informed consent
Age 18 years
BMI 30 kgm² or 25 kgm² with related health conditions
For those with T2DM
Diagnosed for at least six months prior to screening
HbA1c level 12 Exclusion Criteria Exclusion criteria include
Recent significant weight loss 5 kg within the last month
Use of any anti-obesity medications within the past three months
Previous surgical interventions for obesity
Certain medical histories including pancreatitis major depressive disorder and uncontrolled thyroid diseases
Intervention Treatment Allocation All participants will receive semaglutide Fitaro administered subcutaneously once weekly at escalating doses starting from 025 mg up to a maximum of 24 mg based on tolerance and response
Dose Escalation Schedule
Weeks 0-4 Start at 025 mg
Weeks 5-8 Increase to 05 mg
Weeks 9-12 Increase to 1 mg
Weeks 13-16 Increase to 17 mg
Weeks 17 Increase to maximum dose of 24 mg if target weight loss is not achieved
Lifestyle Modifications Participants will receive counseling regarding dietary changes and physical activity tailored to their needs A balanced diet focusing on whole foods portion control and regular exercise will be emphasized
Outcome Measures Primary Endpoint
Change in body weight from baseline at week 26 Secondary Endpoints
Change in BMI
Waist circumference
HbA1c levels
Fasting blood glucose levels
Blood pressure readings
Lipid profiles
Serum uric acid levels
Overall quality of life assessed through the Obesity-Specific Quality of Life instrument OSQOL
Data Collection and Monitoring Data will be collected using semi-structured questionnaires administered at baseline and during follow-up visits at weeks 4 8 12 16 and finally at week 26
A Data and Safety Monitoring Board DSMB will oversee the study integrity by reviewing safety data at regular intervals
Statistical Analysis Plan Data will be analyzed using SPSS software applying mixed effects linear regression models for primary outcomes and appropriate statistical tests for secondary outcomes
Ethical Considerations The study will adhere to ethical standards set forth by Bangabandhu Sheikh Mujib Medical Universitys Institutional Review Board Informed consent will be obtained from all participants prior to enrollment
Conclusion This study aims to provide critical insights into the efficacy and safety of semaglutide for weight management among Bangladeshi adults struggling with obesity or overweight issues presenting an opportunity to enhance treatment strategies tailored to local populations
Even modest weight loss 5-10 of body weight can lead to significant health benefits such as slowing the progression of T2DM and reducing cardiovascular risks Moreover evidence indicates that weight reduction can correlate with an 18 reduction in premature mortality Traditional weight management strategies primarily involve lifestyle modifications such as dietary changes and increased physical activity however many individuals find it difficult to achieve and sustain these changes
While surgical options are available for severe cases of obesity they come with inherent risks and complications that necessitate ongoing follow-up care In this context pharmacotherapy offers a valuable adjunct to lifestyle interventions helping individuals achieve and maintain clinically relevant weight loss while potentially improving coexisting health conditions
Currently there are limited anti-obesity medications available thus there is a pressing need for more effective therapeutic options that can aid in weight maintenance and comorbidity prevention Among the medications approved for long-term use is semaglutide a glucagon-like peptide-1 receptor agonist initially developed for the treatment of T2DM Recent studies have demonstrated its effectiveness in promoting weight loss particularly in Caucasian populations
However existing trials primarily include participants from Europe and North America This raises questions about the applicability of these findings in Asian populations such as those in Bangladesh where genetic and environmental factors can influence obesity outcomes significantly Morphological differences exist between populations for instance central obesity is more prevalent among Caucasians while subcutaneous fat accumulation is common in Asians
In Bangladesh semaglutide Fitaro is available for weight management at various doses 025 mg to 24 mg but there is a lack of specific evidence regarding its efficacy and safety in this demographic This study aims to fill that gap by investigating the effectiveness of semaglutide in overweight or obese individuals with or without T2DM within the Bangladeshi population
Study Objectives and Hypothesis Research Question
What is the role of semaglutide in managing obesity and overweight among the Bangladeshi population Hypotheses
Null Hypothesis Semaglutide is not effective in managing obesity and overweight among the Bangladeshi population
Alternative Hypothesis Semaglutide is effective in managing obesity and overweight among the Bangladeshi population
Objectives
Primary Objective
To assess the efficacy and safety of semaglutide administered once weekly for weight loss in overweight or obese patients with or without T2DM
Secondary Objectives
To evaluate the efficacy and safety of semaglutide for weight reduction in overweight or obese individuals without T2DM
To investigate the efficacy and safety of semaglutide for weight reduction in overweight or obese individuals with T2DM
To compare the efficacy and safety profiles of semaglutide between diabetic and non-diabetic obese patients
To examine the effects of semaglutide on metabolic conditions associated with T2DM hypertension dyslipidemia and hyperuricemia
To assess the impact of semaglutide on quality of life in overweight or obese patients
Methodology Study Design This study will be a single-arm experimental trial conducted in real-world settings across multiple hospitals in Bangladesh including Popular Medical College Hospital Dhaka Medical College Hospital Bangabandhu Sheikh Mujib Medical University and others
Study Population Participants will be grouped into two categories Group A Overweight or obese patients without T2DM Group B Overweight or obese patients with T2DM Sample Size Using OpenEpi software with a significance level set at 95 and a power of 90 we estimate needing a total sample size of approximately 480 participants 240 per group to account for a potential dropout rate of 20
Inclusion Criteria Both diabetic and non-diabetic participants -
Must provide informed consent
Age 18 years
BMI 30 kgm² or 25 kgm² with related health conditions
For those with T2DM
Diagnosed for at least six months prior to screening
HbA1c level 12 Exclusion Criteria Exclusion criteria include
Recent significant weight loss 5 kg within the last month
Use of any anti-obesity medications within the past three months
Previous surgical interventions for obesity
Certain medical histories including pancreatitis major depressive disorder and uncontrolled thyroid diseases
Intervention Treatment Allocation All participants will receive semaglutide Fitaro administered subcutaneously once weekly at escalating doses starting from 025 mg up to a maximum of 24 mg based on tolerance and response
Dose Escalation Schedule
Weeks 0-4 Start at 025 mg
Weeks 5-8 Increase to 05 mg
Weeks 9-12 Increase to 1 mg
Weeks 13-16 Increase to 17 mg
Weeks 17 Increase to maximum dose of 24 mg if target weight loss is not achieved
Lifestyle Modifications Participants will receive counseling regarding dietary changes and physical activity tailored to their needs A balanced diet focusing on whole foods portion control and regular exercise will be emphasized
Outcome Measures Primary Endpoint
Change in body weight from baseline at week 26 Secondary Endpoints
Change in BMI
Waist circumference
HbA1c levels
Fasting blood glucose levels
Blood pressure readings
Lipid profiles
Serum uric acid levels
Overall quality of life assessed through the Obesity-Specific Quality of Life instrument OSQOL
Data Collection and Monitoring Data will be collected using semi-structured questionnaires administered at baseline and during follow-up visits at weeks 4 8 12 16 and finally at week 26
A Data and Safety Monitoring Board DSMB will oversee the study integrity by reviewing safety data at regular intervals
Statistical Analysis Plan Data will be analyzed using SPSS software applying mixed effects linear regression models for primary outcomes and appropriate statistical tests for secondary outcomes
Ethical Considerations The study will adhere to ethical standards set forth by Bangabandhu Sheikh Mujib Medical Universitys Institutional Review Board Informed consent will be obtained from all participants prior to enrollment
Conclusion This study aims to provide critical insights into the efficacy and safety of semaglutide for weight management among Bangladeshi adults struggling with obesity or overweight issues presenting an opportunity to enhance treatment strategies tailored to local populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None