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
Study ID
NCT06616961
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Obesity
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pen — DRUG
    In this study, the intervention involves administering semaglutide (Fitaro) to participants for weight management. The treatment protocol includes the following steps: Initial 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. Dose Escalation: After the initial period, the dose will be increased at four-week intervals as follows: Week 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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Sep 2024
Primary completion
Feb 28, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
480 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    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.

Primary Outcome Measure

Body Weight (kg) [ Time Frame: 26 weeks ]

Central Contacts

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