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NOT YET RECRUITING
NCT06616961
PHASE3

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

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Semaglutide in Weight Reduction in Overweight or Obese Bangladeshi Adults With or Without Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2024-11-01

Completion Date

2026-10

Last Updated

2024-09-27

Healthy Volunteers

No

Interventions

DRUG

Semaglutide Pen

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.

Locations (1)

Popular Medical College Hospital

Dhaka, Bangladesh