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Effect on the tolerability of semaglutide in overweight adults without diabetes
EU CTIS ID: 2025-524612-11-00
What this study is testing
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- 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)
- Known hypersensitivity to semaglutide or its excipients.
- Currently breastfeeding.
See the full eligibility 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
- Able to provide informed consent
- 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
- 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)
- Known hypersensitivity to semaglutide or its excipients.
- Currently breastfeeding.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.