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Could a diabetes drug boost rectal cancer treatment?

NCT ID NCT07314528

Disease control Sponsor: St. James's Hospital, Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a weight-loss medication (a GLP-1 drug) to standard chemo-radiation before surgery helps rectal cancer patients with a high BMI. About 42 participants will either get the drug plus standard treatment or standard treatment alone. Researchers will measure weight loss, tumor response, and survival to see if the drug improves outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight rectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLP - 1 Locally advanced rectal cancer (LARC) Obesity & overweight Rectal cancer patients Total neoadjuvant therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.