DelfaGLP-1 Atlas

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PROSPECT

RecruitingPhase 1

Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Obesity / overweight, Oncology

Key I/E criterion

•BMI 27-40

Primary endpoint

•Urinary PGE-M

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07095517
Org study ID25-460
Secondary ID1OT2CA297680-01
Secondary IDCGCATF-2023/100036Cancer Research UK

Timeline

Milestones

Study first posted2025-07-31actual
Study start2026-02-24actual
Last update posted2026-02-27actual
Primary completion2027-03-31estimated
Study completion2028-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age 18-50 years Because no dosing or adverse event data are currently available on the use of tirzepatide in participants <18 years of age, children are excluded from this study. Because we are specifically studying the prevention of EOCRC, which is defined as CRC occurring prior to age 50, the study population will only enroll participants under the age of 50 at baseline.
•BMI between 27 and 40 kg/m2
•Underwent a screening or surveillance colonoscopy within the prior 9 months.
•Removal of multiple (at least 2) colon or rectal adenomas (including sessile serrated adenomas but excluding hyperplastic polyps) or a single adenoma ≥6mm in size during the last colonoscopy
•Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

•Participants who have ever taken incretin mimetic therapies.
•Participants with a history of medullary thyroid cancer or MEN 2 syndrome.
•Participants at high risk of pancreatitis or otherwise contraindicated for use of tirzepatide according to clinical labeling.
•Participants with a history of cancer (excluding non-melanoma skin) within the last three years
•Participants with a history of diabetes mellitus
•Participants with a history of bowel surgery
•Participants with hereditary cancer syndromes, including HNPCC/Lynch syndrome or familial adenomatous polyposis
•Participants with a history of inflammatory bowel disease, Crohn's, or colitis.
•Participants with incomplete or partial polypectomy during prior colonoscopy.
•Participants who are pregnant. Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating on the study should immediately inform their doctor.

Endpoints (4)

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.

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Change in Urinary PGE-M

Time frame:From enrollment to the end of treatment at 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Plasma GDF-15

Time frame:From enrollment to the end of treatment at 24 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Microbiome

Time frame:From enrollment to the end of treatment at 24 weeks

descriptive

Other/protocol endpoint/low confidence

Change in ISC Marker Gene Expression

Time frame:From enrollment to the end of treatment at 24 weeks

change from baseline, descriptive

Publications (2)

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

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.