Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-08-12
2027-02-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Semaglutide
Semaglutide active drug 0.25-0.5mg, once-weekly, injection
Semaglutide Pen Injector [Ozempic]
Semaglutide active drug
Placebo
Semaglutide placebo, once-weekly, injection
Placebo
semaglutide placebo
Interventions
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Semaglutide Pen Injector [Ozempic]
Semaglutide active drug
Placebo
semaglutide placebo
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* BMI ≥ 18.5
* ECOG performance status\* ≤ 2
* Literate in Danish and/or English
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Independent Research Fund Denmark
INDUSTRY
Klaus Gottlob Müller
OTHER
Responsible Party
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Klaus Gottlob Müller
Professor, consultant
Central Contacts
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References
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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.
Other Identifiers
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2022-502139-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1277-7868
Identifier Type: -
Identifier Source: org_study_id
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