Semaglutide in Auto-HSCT (PROTECT)

Klaus Gottlob Müller

Status and phase: Not yet enrolling; Phase 2

Conditions: Inflammation; Intestinal Mucositis; Chemotherapeutic Toxicity

Treatments: Drug: Placebo; Drug: Semaglutide Pen Injector [Ozempic]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06449625

2022-502139-20-00 (EU Trial (CTIS) Number)

U1111-1277-7868

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Semaglutide

Active Comparator group

Description:

Semaglutide active drug 0.25-0.5mg, once-weekly, injection

Treatment:

Drug: Semaglutide Pen Injector [Ozempic]

Placebo

Placebo Comparator group

Description:

Semaglutide placebo, once-weekly, injection

Treatment:

Drug: Placebo