Efficacy of Oral Semaglutide in Overweight or Obesity (OSO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Drug: oral semaglutide

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rakesh Kalapala, MD DNB; Phone Number: 9989211034; Email: drkalpala@gmail.com
• Study Contact Backup: Name: Anudeep Katrevula, MD DM; Phone Number: 9786025221; Email: anudeep.k65@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • Recruiting
      • Asian Institute of Gastroenterology Hospitals
      • Contact: Rakesh Kalapala, MD DNB; Phone Number: 9989211034; Email: drkalpala@gmail.com
      • Contact: Anudeep Katrevula, MD DM; Phone Number: 9786025221; Email: anudeep.k65@gmail.com
      • Sub-Investigator: Chandana Merugu, MD DM
      • Principal Investigator: Rakesh Kalapala, MD DNB
      • Sub-Investigator: Anudeep Katrevula, MD DNB
      • Principal Investigator: Pratik Chhabra, MD
      • Sub-Investigator: Anand V Kulkarni, MD DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet+excercise+oral semaglutide; 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)	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.; Other Names: Rybelsus tablet
No Intervention: Diet+excercise; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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) ]
Change in waist circumference	measured in cm	baseline (week 0) to end of treatment (week 28)
Change in body mass index (BMI)	measured in kg/m^2	baseline (week 0) to end of treatment (week 28)
Change in systolic blood pressure	measured in mmHg	baseline (week 0) to end of treatment (week 28)
Change in diastolic blood pressure	measured in mmHg	baseline (week 0) to end of treatment (week 28)
Change in fasting serum insulin	Ratio to baseline	baseline (week 0) to end of treatment (week 28)

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Study Chair: chandana merugu, MD DM, Asian Institute of Gastroenterology Hospitals; Study Director: pratik chhabra, MD, Asian Institute of Gastroenterology Hospitals; Principal Investigator: Rakesh kalapala, MD DNB, Asian Institute of Gastroenterology Hospitals; Study Chair: Nitin Jagtap, MD DNB, Asian Institute of Gastroenterology Hospitals; Study Chair: Anand V Kulkarni, MD DM, Asian Institute of Gastroenterology Hospitals; Study Chair: Anudeep Katrevula, MD DM, Asian Institute of Gastroenterology Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 19, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Obesity; Weight Loss; Overweight
• Other Study ID Numbers: AIG/IEC-BH@R 27 /05.2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individuals identity will not be disclosed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No