Efficacy of Oral Semaglutide in Overweight or Obesity

Summary

All the eligible participants after screening will be randomized into two groups (Group 1 and 2) by block randomization (block size of 4 and 6) using computer generated random number. Randomization is performed by the individual not involved in the study.

Participants in both groups will receive individual counselling sessions to help them adhere to a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time) and increased physical activity (with 150 minutes per week of physical activity, such as walking). Both diet and activity will be recorded daily in a diary or by use of a smartphone application or other tools and were reviewed during counselling sessions. Participants in group 1 also receive oral Semaglutide along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance. Dose escalation schedule will be used to decrease the gastrointestinal side effects. Participants will be assessed for gastrointestinal complaints (nausea, vomiting) during escalation and follow-up. Once the desired dose is achieved, patient will remain at the maximum 14mg daily dose unless a reduction was warranted owing to problems with side effects. In such cases, investigators will reescalate the dose once symptoms are resolved or diminished.The absorption of oral Semaglutide is affected by food and fluid in the stomach, hence patients receiving oral Semaglutide will be instructed to take each tablet with up to 120 mL of water in the morning, in a fasting state, and a minimum of 30 min before the first meal of the day. Counselling will be done by a dietician or a similar qualified healthcare professional every 4th week via visits/phone contacts till the completion of the study. Participants have to physically visit the hospital at the end of 28 weeks for assessment.

Conditions

• Obesity
• Weight Loss

Interventions

DRUG

oral semaglutide

Participants in Experimental group will receive oral Semaglutide along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India

  lead OTHER

Principal Investigators

• chandana merugu, MD DM · Asian Institute of Gastroenterology Hospitals

• pratik chhabra, MD · Asian Institute of Gastroenterology Hospitals

• Rakesh kalapala, MD DNB · Asian Institute of Gastroenterology Hospitals

• Nitin Jagtap, MD DNB · Asian Institute of Gastroenterology Hospitals

• Anand V Kulkarni, MD DM · Asian Institute of Gastroenterology Hospitals

• Anudeep Katrevula, MD DM · Asian Institute of Gastroenterology Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-10

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• India

Study Locations