Efficacy of Oral Semaglutide in Overweight or Obesity

NCT05442450 | Unknown Phase 4

• 1 other identifier: AIG/IEC-BH@R 27 /05.2022-03
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The percentage change in body weight from baseline to week 28

  Week 0 to week 28

• Achievement of body weight reduction greater than or equal to 10% (Yes/No)

  From baseline (week 0) to end of treatment (week 28) ]

• Change in waist circumference

  baseline (week 0) to end of treatment (week 28)

• Change in body mass index (BMI)

  baseline (week 0) to end of treatment (week 28)

• Change in systolic blood pressure

  baseline (week 0) to end of treatment (week 28)

Study Arms (2)

Diet+excercise+oral semaglutide

EXPERIMENTAL

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

Diet+excercise

NO INTERVENTION

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).

Interventions

oral semaglutide DRUG

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.

Also known as: Rybelsus tablet

Diet+excercise+oral semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (1)

• Katrevula A, Kalapala R, Agrawal S, Jagtap N, Chhabra P, Kulkarni AV, Merugu C, Katukuri GR, Duvvur NR. Oral semaglutide for weight loss and liver fibrosis in overweight and obesity: A randomized controlled trial. Indian J Gastroenterol. 2025 Oct 9. doi: 10.1007/s12664-025-01856-7. Online ahead of print.

  PMID: 41066034 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• chandana merugu, MD DM

  Asian Institute of Gastroenterology Hospitals

  STUDY CHAIR

• pratik chhabra, MD

  Asian Institute of Gastroenterology Hospitals

  STUDY DIRECTOR

• Rakesh kalapala, MD DNB

  Asian Institute of Gastroenterology Hospitals

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Rakesh kalapala, MD DNB

CONTACT

9989211034; drkalpala@gmail.com

Anudeep Katrevula, MD DM

CONTACT

9786025221; anudeep.k65@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Endoscopy (Center for Obesity and Metabolic Therapy)

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: July 5, 2022
• Study Start: July 10, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)