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Efficacy of Oral Semaglutide in Overweight or Obesity (OSO)

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
oral semaglutide
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asian Institute of Gastroenterology hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diet+excercise+oral semaglutide

Diet+excercise

Arm Description

Participants will receive individual counselling sessions for reduced-calorie diet and physical activity (with 150 minutes per week of physical activity, such as walking). Participants in this group will receive oral Semaglutide drug 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 your symptoms (nausea, vomiting, constipation etc)

Participants in this group will receive individual counselling sessions for reduced-calorie diet and increased physical activity (with 150 minutes per week of physical activity, such as walking).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The percentage change in body weight from baseline to week 28
The percentage change in body weight will be compared between two groups.
Achievement of body weight reduction greater than or equal to 10% (Yes/No)
Count of participants
Change in waist circumference
measured in cm
Change in body mass index (BMI)
measured in kg/m^2
Change in systolic blood pressure
measured in mmHg
Change in diastolic blood pressure
measured in mmHg
Change in fasting serum insulin
Ratio to baseline

Full Information

First Posted
June 19, 2022
Last Updated
July 18, 2022
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT05442450
Brief Title
Efficacy of Oral Semaglutide in Overweight or Obesity
Acronym
OSO
Official Title
Efficacy of Oral Semaglutide in Overweight or Obesity : Randomized Controlled Trial (OSO Study - Oral Semaglutide for Obesity)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet+excercise+oral semaglutide
Arm Type
Experimental
Arm Description
Participants will receive individual counselling sessions for reduced-calorie diet and physical activity (with 150 minutes per week of physical activity, such as walking). Participants in this group will receive oral Semaglutide drug 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 your symptoms (nausea, vomiting, constipation etc)
Arm Title
Diet+excercise
Arm Type
No Intervention
Arm Description
Participants in this group will receive individual counselling sessions for reduced-calorie diet and increased physical activity (with 150 minutes per week of physical activity, such as walking).
Intervention Type
Drug
Intervention Name(s)
oral semaglutide
Other Intervention Name(s)
Rybelsus tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of patients achieving a reduction in body weight of 5% or more from baseline
Description
The proportion of patients achieving a reduction in body weight of 5% or more from baseline
Time Frame
seven months
Secondary Outcome Measure Information:
Title
The percentage change in body weight from baseline to week 28
Description
The percentage change in body weight will be compared between two groups.
Time Frame
Week 0 to week 28
Title
Achievement of body weight reduction greater than or equal to 10% (Yes/No)
Description
Count of participants
Time Frame
From baseline (week 0) to end of treatment (week 28) ]
Title
Change in waist circumference
Description
measured in cm
Time Frame
baseline (week 0) to end of treatment (week 28)
Title
Change in body mass index (BMI)
Description
measured in kg/m^2
Time Frame
baseline (week 0) to end of treatment (week 28)
Title
Change in systolic blood pressure
Description
measured in mmHg
Time Frame
baseline (week 0) to end of treatment (week 28)
Title
Change in diastolic blood pressure
Description
measured in mmHg
Time Frame
baseline (week 0) to end of treatment (week 28)
Title
Change in fasting serum insulin
Description
Ratio to baseline
Time Frame
baseline (week 0) to end of treatment (week 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rakesh kalapala, MD DNB
Phone
9989211034
Email
drkalpala@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anudeep Katrevula, MD DM
Phone
9786025221
Email
anudeep.k65@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chandana merugu, MD DM
Organizational Affiliation
Asian Institute of Gastroenterology hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
pratik chhabra, MD
Organizational Affiliation
Asian Institute of Gastroenterology hospitals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rakesh kalapala, MD DNB
Organizational Affiliation
Asian Institute of Gastroenterology hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nitin Jagtap, MD DNB
Organizational Affiliation
Asian Institute of Gastroenterology hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anand V Kulkarni, MD DM
Organizational Affiliation
Asian Institute of Gastroenterology hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anudeep Katrevula, MD DM
Organizational Affiliation
Asian Institute of Gastroenterology hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Asian Institute of Gastroenterology hospitals
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500032
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakesh Kalapala, MD DNB
Phone
9989211034
Email
drkalpala@gmail.com
First Name & Middle Initial & Last Name & Degree
Anudeep Katrevula, MD DM
Phone
9786025221
Email
anudeep.k65@gmail.com
First Name & Middle Initial & Last Name & Degree
Chandana Merugu, MD DM
First Name & Middle Initial & Last Name & Degree
Nitin Jagtap, MD DNB
First Name & Middle Initial & Last Name & Degree
Rakesh Kalapala, MD DNB
First Name & Middle Initial & Last Name & Degree
Anudeep Katrevula, MD DNB
First Name & Middle Initial & Last Name & Degree
Pratik Chhabra, MD
First Name & Middle Initial & Last Name & Degree
Anand V Kulkarni, MD DM

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individuals identity will not be disclosed

Learn more about this trial

Efficacy of Oral Semaglutide in Overweight or Obesity

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