Effect on the tolerability of semaglutide in overweight adults without diabetes

Authors
Category Primary study
Registry of TrialsClinical Trials Information System
Year 2026
INTERVENTION: Product Name: Rice flour, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: SEMAGLUTIDE, Product Code:SUB32188, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: GRANISETRON, Product Code:SUB07964MIG, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: CONDITION: Overweight and obesity Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] PRIMARY OUTCOME: Main Objective: To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non‐diabetic patients. Primary end point(s): Semaglutide treatment tolerability operationalised as the severity of nausea measured using the 0–10 numeric rating scale (NRS) during the first 96 hours after semaglutide administration. Secondary Objective: To evaluate compliance with semaglutide., To assess the subjective tolerability of semaglutide., To explore the potential modulation of appetite and body weight change., To assess the occurrence of side effects. SECONDARY OUTCOME: Secondary end point(s):Change in appetite Secondary end point(s):Change in body weight from the baseline Secondary end point(s):Incidence and severity of other side effects (vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, headache) Secondary end point(s):Patient self‐reported usage of daily oral study medication. Secondary end point(s):The period mean of the daily well‐being according to numerical rating scale compared between treatment groups. INCLUSION CRITERIA: Adults aged between 18‐70 years, Overweight with BMI 30‐35 kg/m², or BMI 27‐30 kg/m² with at least one overweight‐related comorbidity (hypertension, history of cardiovascular disease (e.g., myocardial infarction, stroke, or heart failure), metabolic dysfunction‐associated steatotic liver disease, osteoarthritis, sleep apnoea)., Has not used semaglutide or other GLP‐1 receptor agonist or acamprosate within the last 3 months, Has not used antiemetics, laxatives, or GI modulators within last 2 months, Is not currently taking medications affecting GI function, Is not diagnosed with diabetes or other serious chronic illness, Women in fertile age must agree to use effective contraception during the whole study period. Acceptable methods are hormonal contraception, intrauterine devices, intrauterine hormone‐releasing systems, bilateral tubal occlusion, vasectomised partner, condom/diaphragm/cervical cap and sexual abstinence., Willingness to comply with study procedures, A
Epistemonikos ID: 72a460bd3b583e63b3d76846ceef8ff07a1fb6c8
First added on: Jul 22, 2026