Effect on the tolerability of semaglutide in overweight adults without diabetes
Key facts
- Where
- Tartu Linn, ÉsztországSee the site
- Phase
- 4. fázis
Where in Észtország
- Tartu University HospitalTartu Linn, ÉsztországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Of Tartu
- Trial code
- EU 2025-524612-11-00
- Record updated
- 2026. május 21.
- Original description
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.Read full original descriptionShow less
Effect of an adjunctive intervention on the tolerability of semaglutide in overweight adults without diabetes: a prospective, randomised, double-blind, single-centre, placebo-controlled clinical trial (SEMTOL)
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.
Inclusion: 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; Able to provide informed consent.
Exclusion: Known hypersensitivity to semaglutide or its excipients; Baseline health status is not acceptable for outpatient therapy: o eGFR ≤45 mL/min/1.73 m²; ASAT and ALAT ≥ 3× ULN (Males ≥150 U/L; Females ≥105 U/L), bilirubin ≥1.5× ULN (≥ 31.5 µmol/L); FSH < 25,8 U/L in women reporting no menstruations ≥1 year; Positive urine strip test for pregnancy in women reporting menstruations within last year; Currently breastfeeding.