Efficacy of Oral Semaglutide in Overweight or Obesity
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.