Efficacy and Safety of Semaglutide for Weight Loss in Overweight or Obese Adults in Bangladesh With or Without Type 2 Diabetes Mellitus

NCT06616961 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: No.BSMMU/2024/7591
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes Mellitus (T2DM)

Keywords

Semaglutide; Obesity; Overweight; Type 2 Diabetes Mellitus (T2DM); Weight Loss; Efficacy; Safety; Bangladesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• BMI (kg/m²)

  26 weeks

• Waist circumference (cm)

  26 weeks

• HbA1C (%)

  26 weeks

• FPG (mmol/l)

  26 weeks

• Systolic blood pressure (mmHg)

  26 weeks

Study Arms (1)

Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide Pen

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.

Also known as: Semaglutide Pen without ADA

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent will be obtained before any trial-related activities
• Male or female, aged ≥ 18 years at the time of signing the informed consent form
• Body mass index (BMI) ≥30 kg/m2 with or without any weight-related comorbidities or ≥25-29.9 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease (more than three months) For subjects with T2DM
• Patients diagnosed with T2DM more than or equal to 180 days prior to the day of screening.
• HbA1c up to 12.0%

You may not qualify if:

• A self-reported reduction in body weight of more than 5 kg within 30 days before screening, irrespective of medical records
• Treatment with any medication for the indication of obesity within the past 90 days before screening (eg. Orlistat, liraglutide, naltrexone/bupropion, diethylpropion, phendimetrazine, and Setmelanotide etc.)
• Any previous obesity treatment with surgery or a weight loss device during lifetime
• Continued treatment with other GLP-1 agonists, SGLT-2 inhibitor and/or metformin. However, if these drugs can be stopped based on the best clinical judgement of the investigator, the patient can be recruited after stopping the drug and a washout period of two weeks. In case of semaglutide (ORSEMA) the wash out period will be 10 weeks.
• Patient taking oral or injectable steroid for other indications
• Past history of pancreatitis
• Diagnosed case of eating disorders eg. Bulimia nervosa
• Patients with a previous history of suicide attempts and major depressive disorder (MDD) according to the DSM-V criteria, schizophrenia or anti-psychotic drug induced obesity
• Patients with a personal or family history of medullary thyroid carcinoma (MTC) and/or multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Known hypersensitivity to Semaglutide or any of the product components.
• History of recent MI (within past three months)
• Pregnancy and lactation Laboratory criteria
• Incidental diagnosis or Uncontrolled thyroid disease, defined as a thyroid stimulating hormone (TSH) level \> 6.0 mIU/L or \<0.4 mIU/L as measured by the central laboratory at screening. However, well-controlled thyroid disorder can be included if TSH\<6.0 or \>0.4 mIU/L.
• Renal impairment, measured as the estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m2 For subjects without T2DM
• HbA1c more than or equal to 48 mmol/mol (6.5%) For subjects with T2DM

Sponsors & Collaborators

• Popular Medical College Hospital: lead
• Pi Research and Development Center, Bangladesh: collaborator
• Incepta Pharmaceuticals Ltd: collaborator

Study Sites (1)

Popular Medical College Hospital

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Central Study Contacts

Mohammad Jahid Hasan, MBBS, MPH

CONTACT

+8801767818973; dr.jahid61@gmail.com

Tamanna Tabassum, MBBS, MPH

CONTACT

+8801755383138; dr.tabassum1991@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 27, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)