Clinical trial

Semaglutide in Auto-HSCT

Opening soon · Phase 2 · 0 countries · Registry ID NCT06449625

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionIntestinal Mucositis, Inflammation, Chemotherapeutic Toxicity

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

Treatments and study arms

Semaglutide Pen Injector [Ozempic]

Drug

Semaglutide active drug

Placebo

Drug

semaglutide placebo

Primary outcomes

gastrointestinal mucositis severityfrom day of stem cell infusion (day 0) to week +3

mean severity grade (0-II)

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.