Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Overweight and obesity
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.
Key facts
- Sponsor
- University Of Tartu
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2026-05-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate whether coadministration of adjunctive therpay affects tolerability of semaglutide in overweight non-diabetic patients.
Secondary objectives 4
- 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.
Conditions and MedDRA coding
Overweight and obesity
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- 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 criteria 6
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 5
- The period mean of the daily well-being according to numerical rating scale compared between treatment groups.
- Patient self-reported usage of daily oral study medication.
- Change in body weight from the baseline
- Change in appetite
- Incidence and severity of other side effects (vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, headache)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.75 mg milligram(s)
- Max total dose
- 0.75 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 1
SUB07964MIG · Substance
- Active substance
- Granisetron
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 6 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Tartu
- Sponsor organisation
- University Of Tartu
- Address
- Ravila Tn 19
- City
- Tartu Linn
- Postcode
- 50411
- Country
- Estonia
Scientific contact point
- Organisation
- University Of Tartu
- Contact name
- UNIVERSITY OF TARTU
Public contact point
- Organisation
- University Of Tartu
- Contact name
- UNIVERSITY OF TARTU
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Tartu University Hospital
Endokrinoloogia osakond, A006, L. Puusepa Tn 8, Tartu Linn
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Annex1_reducted | 1 |
| Protocol (for publication) | Annex2_reducted | 1 |
| Protocol (for publication) | Annex3_reducted | 1 |
| Protocol (for publication) | Annex4 | 1 |
| Protocol (for publication) | Annex5 | 1 |
| Protocol (for publication) | Annex6_redacted | 1.1 |
| Protocol (for publication) | Annex7 | 1 |
| Protocol (for publication) | Annex8 | 1.1 |
| Protocol (for publication) | D1_protocol_redacted_eng_version1 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_eng | 1.1 |
| Recruitment arrangements (for publication) | K2_RecruitmentPosterTextAdditionalInformation_est | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_est_reducted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_rus_reducted | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_semaglutiid_est | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-19 | Estonia | Acceptable 2026-05-12
|
2026-05-21 |