ObesityPhase 4OSONCT05442450
Efficacy of Oral Semaglutide in Overweight or Obesity
A Phase 4 study testing oral semaglutide in people with Obesity and Weight Loss, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- oral semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jul 2022to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology hospitals
Hyderabad, Telangana, 500032
Rakesh Kalapala, MD DNB, 9989211034, drkalpala@gmail.com
Anudeep Katrevula, MD DM, 9786025221, anudeep.k65@gmail.com
About this study
Official title: 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.
- Conditions
- Obesity, Weight Loss
- Being tested
- oral semaglutide
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral semaglutideDrug
Also called Rybelsus tablet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: seven months
Secondary outcomes (7)
The percentage change in body weight from baseline to week 28
The percentage change in body weight will be compared between two groups.
Measured: Week 0 to week 28
Achievement of body weight reduction greater than or equal to 10% (Yes/No)
Count of participants
Measured: From baseline (week 0) to end of treatment (week 28) ]
Change in waist circumference
measured in cm
Measured: baseline (week 0) to end of treatment (week 28)
Change in body mass index (BMI)
measured in kg/m^2
Measured: baseline (week 0) to end of treatment (week 28)
Change in systolic blood pressure
measured in mmHg
Measured: baseline (week 0) to end of treatment (week 28)
Change in diastolic blood pressure
measured in mmHg
Measured: baseline (week 0) to end of treatment (week 28)
Change in fasting serum insulin
Ratio to baseline
Measured: baseline (week 0) to end of treatment (week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start10 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Kalapala, Asian Institute of Gastroenterology, India
- Investigators
- chandana merugu, MD DM, Study chair, Asian Institute of Gastroenterology Hospitalspratik chhabra, MD, Study director, Asian Institute of Gastroenterology HospitalsRakesh kalapala, MD DNB, Principal investigator, Asian Institute of Gastroenterology HospitalsNitin Jagtap, MD DNB, Study chair, Asian Institute of Gastroenterology HospitalsAnand V Kulkarni, MD DM, Study chair, Asian Institute of Gastroenterology HospitalsAnudeep Katrevula, MD DM, Study chair, Asian Institute of Gastroenterology Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442450
- Sponsor's protocol ID
- AIG/IEC-BH@R 27 /05.2022-03
- Acronym
- OSO
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individuals identity will not be disclosed
Publications
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. 2026 Oct;45(5):872-883. doi: 10.1007/s12664-025-01856-7. Epub 2025 Oct 9.
PubMed 41066034
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Semaglutide in Overweight or Obesity : Randomized Controlled Trial (OSO Study - Oral Semaglutide for Obesity)
- ClinicalTrials.gov ID
- NCT05442450
- Acronym / sponsor ID
- OSO / AIG/IEC-BH@R 27 /05.2022-03
- Conditions
- Obesity, Weight Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet+excercise+oral semaglutide | Experimental | Drug: oral semaglutideParticipants 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) |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- • Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral semaglutideAlso: Rybelsus tabletParticipants 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. | Drug | Diet+excercise+oral semaglutide |
Primary outcome
The proportion of patients achieving a reduction in body weight of 5% or more from baseline
Time frame: seven months
The proportion of patients achieving a reduction in body weight of 5% or more from baseline
7 secondary outcomes
The percentage change in body weight from baseline to week 28
Time frame: Week 0 to week 28
Achievement of body weight reduction greater than or equal to 10% (Yes/No)
Time frame: From baseline (week 0) to end of treatment (week 28) ]
Change in waist circumference
Time frame: baseline (week 0) to end of treatment (week 28)
Change in body mass index (BMI)
Time frame: baseline (week 0) to end of treatment (week 28)
Change in systolic blood pressure
Time frame: baseline (week 0) to end of treatment (week 28)
Change in diastolic blood pressure
Time frame: baseline (week 0) to end of treatment (week 28)
Change in fasting serum insulin
Time frame: baseline (week 0) to end of treatment (week 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 41066034Katrevula 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. 2026 Oct;45(5):872-883. doi: 10.1007/s12664-025-01856-7. Epub 2025 Oct 9.
- Individual participant dataSharing planned: No. Individuals identity will not be disclosed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chandana merugu, MD DM study chair
Asian Institute of Gastroenterology Hospitals
pratik chhabra, MD study director
Asian Institute of Gastroenterology Hospitals
Rakesh kalapala, MD DNB principal investigator
Asian Institute of Gastroenterology Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral semaglutide in people with Obesity and Weight Loss, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rakesh kalapala, MD DNB (9989211034, drkalpala@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving a reduction in body weight of 5% or more from baseline (time frame: seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.