GLP-1 Peptide Atlas, by Delfa

Not yet recruitingPhase 2

Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer

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

Lead sponsor

St. James's Hospital, Ireland

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight, Oncology

Key I/E criterion

•BMI ≥25

Primary endpoints

•Body weight, absolute change (kg)•Metabolic Profile of the Tissue•Inflammatory Mediators

Identifiers

Registered as

NCT IDNCT07314528

Org study ID435911714

Timeline

Milestones

Study first posted2026-01-02actual

Last update posted2026-01-02actual

Study start2026-04estimated (month precision)

Primary completion2028-09estimated (month precision)

Study completion2028-09estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Written informed consent according to local guidelines obtained prior to any study-related activities.

•Histologically confirmed mismatch repair protein proficient adenocarcinoma of the rectum.

•BMI ≥25 kg/m²

•Radiological confirmed >T2, Node positive, Threatened Surgical Margin and/or EMVI+ by MRI

•Imaging available for radiomics analysis

•Absence of metastatic disease at registration.

•Adequate renal function is defined as calculated creatinine clearance (CrCl) >50ml/min.

•ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3, total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN

•Able to tolerate medication.

•ECOG 0-2

Exclusion criteria

•Received prior chemotherapy or radiotherapy

•Previous or concurrent active malignancy ≤ 5 years prior to registration, with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating investigator does not feel will impact the study objectives.

•Locally advanced disease T3N+ or T4 disease.

•Recurrent rectal cancer

•Metastatic disease at presentation

•Patients unable to undergo MRI

•Patients having already received weight-loss intervention (pharmacological or surgical)

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Other clinical outcomes

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

3 endpoints

Primary/protocol endpoint

Weight Loss

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Metabolic and Physiologic Outcomes:

Time frame:From enrolment to surgical resection within 1 year

change from baseline, improvement

componentsBMI, change, Waist circumference, change, Visceral fat, change

Secondary/protocol endpoint/low confidence

Metabolic and Physiologic Outcomes:

Time frame:Enrolment to 1 year

descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint/low confidence

Metabolic and Physiologic Outcomes:

Time frame:From enrolment to 1 year

change from baseline, improvement

Secondary/protocol endpoint

Translational Component: to investigate the molecular and cellular effects of GLP-1 RA therapy during TNT through analysis of tissue and blood biomarkers.

Time frame:From enrolment to1 year

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Patient-Reported Outcomes:

Time frame:2 years

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Treatment Tolerability and Safety:

Time frame:1 year

Treatment-emergent AEs (any)

descriptive, event

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint/low confidence

Oncological outcomes

Time frame:5 years

descriptive, event

componentspathological complete response, overall survival, disease-free survival, local recurrence

Secondary/protocol endpoint/low confidence

Surgical Outcomes

Time frame:Enrolment to surgical intervention and 30 days post discharge

descriptive

Secondary/protocol endpoint

Surgical Outcomes

Time frame:30 days

descriptive, event

componentsanastomotic leak, wound infection, ileus

Secondary/protocol endpoint/low confidence

Surgical Outcomes

Time frame:30 days

event count, event

componentsAll-cause hospitalization

Other (unclassified)

12 endpoints

Primary/protocol endpoint/low confidence

Metabolic Profile of the Tissue

Time frame:From enrolment to operation within 1 year

descriptive

Primary/protocol endpoint/low confidence

Inflammatory Mediators

Time frame:From enrolment to surgical resection within 1 year

descriptive

Primary/protocol endpoint/low confidence

GLP-1 effects on mitochondrial fitness

Time frame:From enrolment to surgical resection within 1 year

descriptive

Primary/protocol endpoint/low confidence

Mapping systemic inflammatory profiles

Time frame:From enrolment to surgical resection within 1 year

descriptive

Primary/protocol endpoint/low confidence

Mapping circulating immune systems

Time frame:From enrolment to surgical resection within 1 year

descriptive

Primary/protocol endpoint/low confidence

Mapping tumour resident immune system

Time frame:From enrolment to surgical resection within 1 year

descriptive

Secondary/protocol endpoint/low confidence

Translational Component: to investigate the molecular and cellular effects of GLP-1 RA therapy during TNT through analysis of tissue and blood biomarkers.

Time frame:From enrolment to surgical resection within 1 year

descriptive

Secondary/protocol endpoint/low confidence

Radiomics

Time frame:From enrolment to surgical resection within 1 year

descriptive

Secondary/protocol endpoint/low confidence

Circulating Tumor DNA (ctDNA)

Time frame:From enrolment to surgical resection within 1 year

descriptive

Secondary/protocol endpoint/low confidence

Translational Component: to investigate the molecular and cellular effects of GLP-1 RA therapy during TNT through analysis of tissue and blood biomarkers.

Time frame:Enrolment to 1 year

descriptive

Secondary/protocol endpoint/low confidence

Translational Component: to investigate the molecular and cellular effects of GLP-1 RA therapy during TNT through analysis of tissue and blood biomarkers.

Time frame:Enrolment to 1 year

descriptive

Secondary/protocol endpoint/low confidence

Translational Component: to investigate the molecular and cellular effects of GLP-1 RA therapy during TNT through analysis of tissue and blood biomarkers.

Time frame:Enrolment to 1 year

descriptive

Publications (12)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

GLP-1 receptor agonists and the risk for cancer: A meta-analysis of randomized controlled trials.
Diabetes, obesity & metabolism2025 Aug (month)PMID40437949doi:10.1111/dom.16489via CT.gov reference
GLP-1 receptor agonists in the context of cancer: the road ahead.
American journal of physiology. Cell physiology2025 Jun 1PMID40285503doi:10.1152/ajpcell.00245.2025via CT.gov reference
Glucagon-like peptide 1 receptor agonists and cancer risk: advancing precision medicine through mechanistic understanding and clinical evidence.
Biomarker research2025 Mar 27PMID40140925doi:10.1186/s40364-025-00765-3via CT.gov reference
Clinical Validity and Utility of Circulating Tumor DNA (ctDNA) Testing in Advanced Non-small Cell Lung Cancer (aNSCLC): A Systematic Literature Review and Meta-analysis.
Molecular diagnosis & therapy2024 Sep (month)PMID39093546doi:10.1007/s40291-024-00725-xvia CT.gov reference
Glucagon-Like Peptide 1 Receptor Agonists and 13 Obesity-Associated Cancers in Patients With Type 2 Diabetes.
JAMA network open2024 Jul 1PMID38967919doi:10.1001/jamanetworkopen.2024.21305via CT.gov reference
Total Neoadjuvant Therapy for Rectal Cancer: Which Regimens to Use?
Cancers2024 May 31PMID38893212doi:10.3390/cancers16112093via CT.gov reference
The impact of obesity on postoperative outcomes following surgery for colorectal cancer: analysis of the National Inpatient Sample 2015-2019.
ANZ journal of surgery2024 Jul-Aug (year)PMID38888262doi:10.1111/ans.19135via CT.gov reference
Total neoadjuvant therapy for rectal cancer: a guide for surgeons.
Canadian journal of surgery. Journal canadien de chirurgie2023 Mar-Apr (year)PMID37085291doi:10.1503/cjs.005822via CT.gov reference
Prognostic and Predictive Biomarkers in Patients with Locally Advanced Rectal Cancer (LARC) Treated with Preoperative Chemoradiotherapy.
Journal of clinical medicine2022 Oct 16PMID36294412doi:10.3390/jcm11206091via CT.gov reference
The Prognostic Importance of ctDNA in Rectal Cancer: A Critical Reappraisal.
Cancers2022 Apr 30PMID35565381doi:10.3390/cancers14092252via CT.gov reference
Once-Weekly Semaglutide in Adults with Overweight or Obesity.
The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov reference
Delivery of Personalized Care for Locally Advanced Rectal Cancer: Incorporating Pathological, Molecular Genetic, and Immunological Biomarkers Into the Multimodal Paradigm.
Frontiers in oncology2020 (year)PMID32923389doi:10.3389/fonc.2020.01369via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.