NCT05442450: OSO

Efficacy of Oral Semaglutide in Overweight or Obesity

Status unknown Phase 4 Last updated 20 July 2022

What this trial tests

Phase 4 trial testing oral semaglutide in Obesity in 116 participants. Status unknown.

Timeline

10 July 2022

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Asian Institute of Gastroenterology, India
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	10 July 2022
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across India

Drugs / interventions tested

• oral semaglutide

Conditions studied

• Obesity — all drugs for Obesity →
• Weight Loss — all drugs for Weight Loss →

Sponsor

Asian Institute of Gastroenterology, India

Who can join

18 and older, any sex, with Obesity or Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.