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Taking people in EstoniaPhase 4

Tests an add-on treatment with semaglutide in adults with overweight

Tests whether an added treatment changes how well semaglutide is tolerated by adults with overweight.

Key facts

Who runs it
University Of Tartu
Where
Tartu Linn, EstoniaSee the site
Registry title
Effect on the tolerability of semaglutide in overweight adults without diabetes
Status
Recruiting
Phase
Phase 4
People taking part
100 people, planned
Started
20 Jul 2026
Expected to end
31 Oct 2028
Type of study
Interventional
Record updated
21 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Estonia

  • Tartu University HospitalTartu Linn, EstoniaTaking people

About the trial

What the trial wants to find out

To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests an add-on treatment with semaglutide in adults with overweightGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
21 May 2026