Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 4:09 PM
Study NCT ID:
NCT06616961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
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:
Popular Medical College Hospital
Organization:
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:
False
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 (2.4 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 (2.4 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 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, with a notable mortality rate of 62.6 deaths per 100,000 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 (0.25 mg to 2.4 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 kg/m² or ≥25 kg/m² 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 0.25 mg up to a maximum of 2.4 mg, based on tolerance and response.
Dose Escalation Schedule
* Weeks 0-4: Start at 0.25 mg
* Weeks 5-8: Increase to 0.5 mg
* Weeks 9-12: Increase to 1 mg
* Weeks 13-16: Increase to 1.7 mg
* Weeks 17+: Increase to maximum dose of 2.4 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 University's 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 (0.25 mg to 2.4 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 kg/m² or ≥25 kg/m² 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 0.25 mg up to a maximum of 2.4 mg, based on tolerance and response.
Dose Escalation Schedule
* Weeks 0-4: Start at 0.25 mg
* Weeks 5-8: Increase to 0.5 mg
* Weeks 9-12: Increase to 1 mg
* Weeks 13-16: Increase to 1.7 mg
* Weeks 17+: Increase to maximum dose of 2.4 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 University's 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:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: