Intestinal MucositisPhase 2PROTECTNCT06449625
Semaglutide in Auto-HSCT
A Phase 2 study testing Semaglutide Pen Injector [Ozempic] in people with Intestinal Mucositis and Inflammation, run by Klaus Gottlob Müller.
Trial summary
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Mucositis, Inflammation, Chemotherapeutic Toxicity
- What is being tested?
- Semaglutide Pen Injector [Ozempic]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2024to 1 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma
- Age ≥ 18 years
- BMI ≥ 18.5
- ECOG performance status* ≤ 2
- Literate in Danish and/or English
Who cannot join
- Diabetes
- Inflammatory bowel disease
- Previous or current gastrointestinal malignancy
- Personal or family history of medullary thyroid carcinoma or MEN syndrome
- Genetic disorders with defective tissue repair (e.g., Fanconi anaemia)
- History of pancreatitis (acute or chronic)
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- Renal impairment measured as eGFR value of < 30 ml/min/1.73 m2
- Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times upper normal limit at screening
- Known or suspected hypersensitivity to semaglutide or other GLP-1RA
- Pregnant or nursing females
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.
Study design:
Read more
The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up.
Study population:
A planned total number of 40 patients will be randomized.
- Being tested
- Semaglutide Pen Injector [Ozempic], Placebo
- Keywords
- Gut epithelial barrier, Chemotherapy-induced toxicity, Growth factor
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen Injector [Ozempic]Drug
Semaglutide active drug
PlaceboDrug
semaglutide placebo
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Active comparator | Semaglutide active drug 0.25-0.5mg, once-weekly, injection Receives: Drug: Semaglutide Pen Injector [Ozempic] |
| Placebo | Placebo comparator | Semaglutide placebo, once-weekly, injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal mucositis severity
mean severity grade (0-II)
Measured: from day of stem cell infusion (day 0) to week +3
Secondary outcomes (4)
CRP increment
AUC
Measured: from day of stem cell infusion (day 0) to week +3
Quality of life general
evaluated by EORTC QLQ-C30 questionnaire. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores (excluding global QoL and financial impact). Final scoring range: 0-100 with a higher score indicating a better quality of life
Measured: change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Quality of life - high-dose chemotherapy treatment specific
evaluated by EORTC QLQ-HDC29 questionnaire. The QLQ HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 singleitems. Final scoring range: 0-100 with a higher score indicating a better quality of life
Measured: change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Safety profile evaluated by number of SARs
SAR will be estimated according to ICH-GCP guidelines
Measured: Start of study drug treatment (week 1) until study week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start12 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klaus Gottlob Müller
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Independent Research Fund Denmark
- Responsible party
- Sponsor-investigator, Klaus Gottlob Müller, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449625
- Sponsor's protocol ID
- U1111-1277-7868
- Other IDs
- 2022-502139-20-00
- Acronym
- PROTECT
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorum ME, Gang AO, Tholstrup DM, Gudbrandsdottir S, Kissow H, Kornblit B, Muller K, Knop FK. Semaglutide treatment for PRevention Of Toxicity in high-dosE Chemotherapy with autologous haematopoietic stem-cell Transplantation (PROTECT): study protocol for a randomised, double-blind, placebo-controlled, investigator-initiated study. BMJ Open. 2024 Oct 9;14(10):e089862. doi: 10.1136/bmjopen-2024-089862.
PubMed 39384243
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06449625
- Acronym / sponsor ID
- PROTECT / U1111-1277-7868
- Keywords
- Gut epithelial barrier, Chemotherapy-induced toxicity, Growth factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Klaus Gottlob MüllerUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Independent Research Fund Denmark
- Study start
- 12 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.
Study design:
The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up.
Study population:
A planned total number of 40 patients will be randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Active comparator | Drug: Semaglutide Pen Injector [Ozempic]Semaglutide active drug 0.25-0.5mg, once-weekly, injection |
| Placebo | Placebo comparator | Drug: PlaceboSemaglutide placebo, once-weekly, injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma
- Age ≥ 18 years
- BMI ≥ 18.5
- ECOG performance status* ≤ 2
- Literate in Danish and/or English
Key exclusion criteria (10 listed)
- Diabetes
- Inflammatory bowel disease
- Previous or current gastrointestinal malignancy
- Personal or family history of medullary thyroid carcinoma or MEN syndrome
- Genetic disorders with defective tissue repair (e.g., Fanconi anaemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen Injector [Ozempic]Semaglutide active drug | Drug | Semaglutide |
| Placebosemaglutide placebo | Drug | Placebo |
Primary outcome
gastrointestinal mucositis severity
Time frame: from day of stem cell infusion (day 0) to week +3
mean severity grade (0-II)
4 secondary outcomes
CRP increment
Time frame: from day of stem cell infusion (day 0) to week +3
Quality of life general
Time frame: change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Quality of life - high-dose chemotherapy treatment specific
Time frame: change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Safety profile evaluated by number of SARs
Time frame: Start of study drug treatment (week 1) until study week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Derived from this study: PubMed 39384243Sorum ME, Gang AO, Tholstrup DM, Gudbrandsdottir S, Kissow H, Kornblit B, Muller K, Knop FK. Semaglutide treatment for PRevention Of Toxicity in high-dosE Chemotherapy with autologous haematopoietic stem-cell Transplantation (PROTECT): study protocol for a randomised, double-blind, placebo-controlled, investigator-initiated study. BMJ Open. 2024 Oct 9;14(10):e089862. doi: 10.1136/bmjopen-2024-089862.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide Pen Injector [Ozempic] in people with Intestinal Mucositis and Inflammation, run by Klaus Gottlob Müller.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ebbesen Sørum, MD, PhD (004540638545, maria.ebbesen.soerum@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal mucositis severity (time frame: from day of stem cell infusion (day 0) to week +3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.