LivingGLP1
Study S002389

A Phase II Multi-institutional Randomized Trial Evaluating the Impact of GLP-1 Receptor Agonists in Combination With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

ClinicalTrials.gov record

Registration

Registration
NCT07314528
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
NONE
Status
NOT_YET_RECRUITING
Enrollment
42
Start
2026-04
Primary completion
2028-09
Lead sponsor
St. James's Hospital, Ireland
Conditions
Rectal Cancer Patients; Obesity &Amp; Overweight; Locally Advanced Rectal Cancer (LARC); Total Neoadjuvant Therapy; GLP-1
Interventions
DRUG:GLP-1 receptor agonist; DRUG:Total neoadjuvant therapy (TNT)
Results posted
FALSE
Individual participant data sharing
NO

Registered primary outcomes

  • Weight Loss [6 months]
  • Metabolic Profile of the Tissue [From enrolment to operation within 1 year]
  • Inflammatory Mediators [From enrolment to surgical resection within 1 year]
  • GLP-1 effects on mitochondrial fitness [From enrolment to surgical resection within 1 year]
  • Mapping systemic inflammatory profiles [From enrolment to surgical resection within 1 year]
  • Mapping circulating immune systems [From enrolment to surgical resection within 1 year]
  • Mapping tumour resident immune system [From enrolment to surgical resection within 1 year]

Linked records (6)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0001224Evaluating the impact of GLP-1 receptor agonists in combination with total neoadjuvant therapy for locally advanced rectal cancer.
Temperley HC, The British journal of surgery
2026Narrative reviewPMID 41806363DOIcites ClinicalTrials.gov:NCT07314528; registry reference DERIVED:41806363
R0002557GLP-1 receptor agonists in the context of cancer: the road ahead.
Miousse IR, American journal of physiology. Cell physiology
2025Narrative reviewPMID 40285503DOIregistry reference RESULT:40285503
R0002927Glucagon-like peptide 1 receptor agonists and cancer risk: advancing precision medicine through mechanistic understanding and clinical evidence.
Lin A, Biomarker research
2025Narrative reviewPMID 40140925DOIregistry reference RESULT:40140925
R0006091GLP-1 receptor agonists and the risk for cancer: A meta-analysis of randomized controlled trials.
Silverii GA, Diabetes, obesity & metabolism
2025Systematic reviewPMID 40437949DOIregistry reference RESULT:40437949
R0006897Glucagon-Like Peptide 1 Receptor Agonists and 13 Obesity-Associated Cancers in Patients With Type 2 Diabetes.
Wang L, JAMA network open
2024Nonrandomized studyPMID 38967919DOIregistry reference RESULT:38967919
R0023399Once-Weekly Semaglutide in Adults with Overweight or Obesity.
Wilding JPH, The New England journal of medicine
2021Randomized trialPMID 33567185DOIregistry reference RESULT:33567185