GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer

What Was Tested

In this early phase 1 trial, researchers set out to test Semaglutide.

There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s.

To date, no clinical trial data exists to establish safety and/or feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting.

It had three arms (groups): Metastatic Pancreatic Adenocarcinoma (PDAC) (experimental), Metastatic Colorectal Adenocarcinoma (CRC) (experimental) and Metastatic Hepatocellular Carcinoma (HCC) (experimental).

30 patients with a diagnosis of 1st line metastatic or unresectable PDAC, CRC, or HCC and a BMI \>25 will receive GLP1 RA weekly + SOC treatment for 6 months or disease progression whichever comes first. SOC treatment for pancreatic cancer is modified FOLFIRINOX.

10 patients with a diagnosis of 1st line metastatic or unresectable CRC and a BMI \>25 will receive GLP1 RA weekly + SOC treatment for 6 months or disease progression whichever comes first. SOC treatment for CRC is FOLFOX or FOLFIRI +/- bevacizumab.

10 patients with a diagnosis of 1st line metastatic or unresectable HCC and a BMI \>25 will receive GLP1 RA weekly + SOC treatment for 6 months or disease progression whichever comes first. SOC treatment for HCC is Tremelimumab/Durvalumab.

The registry classes the interventions as drug.

More on the Plan

This rise has been driven by a combination of poor dietary habits, sedentary lifestyles, and social and economic factors that limit access to healthy food and healthcare.

Disparities are evident, with higher rates among Black, Hispanic, Native American, low-income, and rural populations, largely due to systemic barriers and social determinants of health.

In response, public health initiatives have promoted better nutrition, physical activity, and early intervention programs.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the "additional HCC cohort criteria" below. The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease). Measurable disease per RECIST v1.1 as determined by the investigator. Patients must be appropriate candidates for first-line, SOC treatment. SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to:.

The full record lists 30 inclusion and 55 exclusion criteria; among the exclusions: the subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) for metastatic and/or unresectable disease; BMI \< 25 kg/m2; for colorectal cancer only - microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) tumors.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2026-10-10 with completion listed for 2028-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of Treatment Emergent Adverse Events [Safety] attributed to GLP1-RA and/or its interaction with chemotherapy (time frame: Up to 6 months or at time of disease progression, whichever comes first).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Semaglutide in 30 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.