Overview
Sponsor-declared trial summary
Mucositis and systemical inflammation, which is a treatment-related complication after treatment with high-dose chemotherapy
To evaluate the effect of semaglutide in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) hematopoietic stem cell transplantation (HSCT).
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Sep 2024 → ongoing
- Decision date (initial)
- 2023-03-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502139-20-00
- WHO UTN
- U1111-1277-7868
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Prophylaxis
To evaluate the effect of semaglutide in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) hematopoietic stem cell transplantation (HSCT).
Secondary objectives 1
- To evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.
Conditions and MedDRA coding
Mucositis and systemical inflammation, which is a treatment-related complication after treatment with high-dose chemotherapy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma
- Age ≥ 18 years
- BMI ≥ 18.5
- ECOG performance status ≤ 2
- Literate in Danish and/or English
Exclusion criteria 10
- Diabetes
- Previous or current gastrointestinal malignancy
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. Family is defined as a first degree relative
- Genetic disorders with defective tissue repair (e.g. Fanconi anaemia)
- History of pancreatitis (acute or chronic)
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 30 ml/min/1.73 m2 as defined by KDIGO 2012 classification4
- Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
- Known or suspected hypersensitivity to semaglutide or other GLP-1RA
- Inflammatory bowel disease
- Pregnant or nursing females
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- GI mucositis severity: mean severity grade (0-II) from study week 5 to 9
Secondary endpoints 3
- CRP increment in the early post-transplant phase: area under the plasma concentration-time curve (AUC) from study week 5 to 8
- Quality of life (QOL): change from baseline (study week 4) to study week 9 and 18 evaluated by EORTC QLQ-C30 and EORTC QLQ-HDC29 questionnaires
- Safety profile: evaluated by SAR according to ICH-GCP guidelines
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ozempic 0.25 mg solution for injection in pre-filled pen
PRD6392561 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/002
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Klaus Müller
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Klaus Müller
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| University Of Copenhagen ORG-100030460
|
Frederiksberg C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-09-09 | 2024-09-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study Protocol_PROTECT | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | ozempic-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | Protocol summary_PROTECTv2 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-22 | Denmark | Acceptable 2023-02-22
|
2023-03-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-19 | Denmark | Acceptable 2023-02-22
|
2025-05-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-02 | Denmark | Acceptable 2025-06-18
|
2025-06-18 |