2025-524612-11-00RecruitingPhase 4
Effect on the tolerability of semaglutide in overweight adults without diabetes
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 May 2026
Brief summary (registry, in English)
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Feb 2026
- Start date
- 20 Jul 2026
- Lead sponsor
- University Of Tartu
- Diseases
- Obesity
- EU CT number
- 2025-524612-11-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-70 who are overweight and do not have diabetes. It tests whether an add-on treatment changes how well semaglutide is tolerated.
- Age
- 18-70 years
- Sex
- All sexes can join.
- Disease stage
- Overweight with BMI 30-35 kg/m², or BMI 27-30 kg/m² with at least one overweight-related condition (high blood pressure, past heart disease such as heart attack, stroke or heart failure, fatty liver disease, osteoarthritis, sleep apnoea).
- Earlier treatment
- No semaglutide, other GLP-1 receptor agonist or acamprosate in the last 3 months. No antiemetics, laxatives or gut-modulating medicines in the last 2 months. No current medicines that affect gut function.
Main reasons for not taking part
- Diabetes or another serious long-term illness
- Pregnancy, or currently breastfeeding
- eGFR 45 mL/min/1.73 m² or lower
- High liver tests: ASAT and ALAT 3 times the upper limit of normal or more, or bilirubin 1.5 times the upper limit or more
- Known allergy to semaglutide or its ingredients
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to semaglutide or its excipients.
Lab values
- 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)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tartu University Hospital | Tartu Linn | Estonia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.