Clinical trial NCT05442450: Efficacy of Oral Semaglutide in Overweight or Obesity
Official title: Efficacy of Oral Semaglutide in Overweight or Obesity : Randomized Controlled Trial (OSO Study - Oral Semaglutide for Obesity)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Weight Loss
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The proportion of patients achieving a reduction in body weight of 5% or more from baseline
timeFrame: seven months
Secondary outcomes:
measure: The percentage change in body weight from baseline to week 28
timeFrame: Week 0 to week 28
measure: Achievement of body weight reduction greater than or equal to 10% (Yes/No)
timeFrame: From baseline (week 0) to end of treatment (week 28) ]
measure: Change in waist circumference
timeFrame: baseline (week 0) to end of treatment (week 28)
measure: Change in body mass index (BMI)
timeFrame: baseline (week 0) to end of treatment (week 28)
measure: Change in systolic blood pressure
timeFrame: baseline (week 0) to end of treatment (week 28)
measure: Change in diastolic blood pressure
timeFrame: baseline (week 0) to end of treatment (week 28)
measure: Change in fasting serum insulin
timeFrame: baseline (week 0) to end of treatment (week 28)
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology hospitals
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology Hospitals
name: chandana merugu, MD DM
role: STUDY_CHAIR
affiliation: Asian Institute of Gastroenterology Hospitals
name: pratik chhabra, MD
role: STUDY_DIRECTOR
affiliation: Asian Institute of Gastroenterology Hospitals
name: Rakesh kalapala, MD DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Institute of Gastroenterology Hospitals
name: Nitin Jagtap, MD DNB
role: STUDY_CHAIR
affiliation: Asian Institute of Gastroenterology Hospitals
name: Anand V Kulkarni, MD DM
role: STUDY_CHAIR
affiliation: Asian Institute of Gastroenterology Hospitals
name: Anudeep Katrevula, MD DM
role: STUDY_CHAIR
References: