Semaglutide in Auto-HSCT

Sponsor
Klaus Gottlob Müller
Study ID
NCT06449625
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chemotherapeutic Toxicity
  • Inflammation
  • Intestinal Mucositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 12, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Semaglutide
    Semaglutide active drug 0.25-0.5mg, once-weekly, injection
  • Placebo Comparator: Placebo
    Semaglutide placebo, once-weekly, injection

Primary Outcome Measure

gastrointestinal mucositis severity [ Time Frame: from day of stem cell infusion (day 0) to week +3 ]

Central Contacts

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