Efficacy of Oral Semaglutide in Overweight or Obesity

Obesity Clinical Trial

— OSO  

Official title:

Efficacy of Oral Semaglutide in Overweight or Obesity : Randomized Controlled Trial (OSO Study - Oral Semaglutide for Obesity)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442450
• Other study ID #: AIG/IEC-BH@R 27 /05.2022-03
• Status: Recruiting
• Phase: Phase 4
• Start date: July 10, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Asian Institute of Gastroenterology, India
• Contact: Rakesh kalapala, MD DNB
• Phone: 9989211034
• Email: drkalpala[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive consenting patients of both genders with either a BMI of 30 or greater or a BMI of 27 or greater with one or more treated or untreated weight-related coexisting conditions (i.e., prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).

Exclusion Criteria:

• • Diabetes mellitus

• A glycated haemoglobin level of 48 mmol per mole (6.5%) or greater,

• A history of chronic pancreatitis

• Acute pancreatitis within 180 days before enrolment

• Previous surgical obesity treatment

• Use of antiobesity medication within 90 days before enrolment

• Pregnancy and planning for pregnancy

• Known malignancy

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients achieving a reduction in body weight of 5% or more from baseline	The proportion of patients achieving a reduction in body weight of 5% or more from baseline	seven months
Secondary	The percentage change in body weight from baseline to week 28	The percentage change in body weight will be compared between two groups.	Week 0 to week 28
Secondary	Achievement of body weight reduction greater than or equal to 10% (Yes/No)	Count of participants	From baseline (week 0) to end of treatment (week 28) ]
Secondary	Change in waist circumference	measured in cm	baseline (week 0) to end of treatment (week 28)
Secondary	Change in body mass index (BMI)	measured in kg/m^2	baseline (week 0) to end of treatment (week 28)
Secondary	Change in systolic blood pressure	measured in mmHg	baseline (week 0) to end of treatment (week 28)
Secondary	Change in diastolic blood pressure	measured in mmHg	baseline (week 0) to end of treatment (week 28)
Secondary	Change in fasting serum insulin	Ratio to baseline	baseline (week 0) to end of treatment (week 28)