Semaglutide in Auto-HSCT

NCT06449625 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: U1111-1277-78682022-502139-20-00
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Intestinal Mucositis; Inflammation; Chemotherapeutic Toxicity

Keywords

Gut epithelial barrier; Chemotherapy-induced toxicity; Growth factor

Outcome Measures

Primary Outcomes (1)

• gastrointestinal mucositis severity

  mean severity grade (0-II)

  from day of stem cell infusion (day 0) to week +3

Secondary Outcomes (4)

• CRP increment

  from day of stem cell infusion (day 0) to week +3

• Quality of life general

  change from baseline (start of high-dose chemotherapy) to study week 9 and 18

• Quality of life - high-dose chemotherapy treatment specific

  change from baseline (start of high-dose chemotherapy) to study week 9 and 18

• Safety profile evaluated by number of SARs

  Start of study drug treatment (week 1) until study week 10

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

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

Drug: Semaglutide Pen Injector [Ozempic]

Placebo

PLACEBO COMPARATOR

Semaglutide placebo, once-weekly, injection

Drug: Placebo

Interventions

Semaglutide Pen Injector [Ozempic] DRUG

Semaglutide active drug

Semaglutide

Placebo DRUG

semaglutide placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klaus Gottlob Müller: lead
• Novo Nordisk A/S: collaborator
• Independent Research Fund Denmark: collaborator

Related Publications (1)

• 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.

  PMID: 39384243 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Ebbesen Sørum, MD, PhD

CONTACT

004540638545; maria.ebbesen.soerum@regionh.dk

Klaus Müller, DMSc

CONTACT

004525325559; klaus.mueller@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, consultant

Model Details: randomized 1:1

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 10, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share