Blocking of the Gut Hormone Receptor for Glucagon-like Peptide 2 (GLP-2) by the GLP-2 Receptor Antagonist GLP-2(3-33) (GLP-2ant)

April 29, 2025 updated by: University of Copenhagen

Antagonist of the Glucagon-like Peptide 2 (GLP-2) Receptor

This project will describe the role of physiological levels of GLP-2 in regulating the blood flow to the intestines and the effect of the antagonist GLP-2(3-33) in blocking these effects of GLP-2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ten healthy participants will meet fasting and attend four randomized experimental days of MRI-scans of the abdomen. Each day will include subcutaneous injections of GLP-2 or saline and intravenous infusion of either the GLP-2 (3-33) antagonist or saline. The infusion start at timepoint -20, while the subcutaneous injection is given to timepoint 0 and the participant will lay in the scanner in one hour after injection. Eight MR-scans are done repeatedly to measure the blood flow in larger abdominal vessels and four blood samples are taken during the experimental day for analysis of GLP-2(1-33), GLP-2(3-33) and bone markers.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-70 years
  • BMI 19-28 kg/m2

Exclusion Criteria:

  • Chronic illness that affects the cardiovascular system or gastrointestinal tract
  • Treatment with medicine or supplements that cannot be paused for 12 hours
  • Intake of above 14 alcoholic drinks per week or substance abuse
  • Liver enzymes (ALAT) above 2 times normal values
  • Decreased kidney function (eGFR below 90 or creatinine levels over reference value)
  • Low blood percentage (hemoglobin below reference value)
  • Any condition or disease that the persons responsible for the study find would interfere with the participation of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline injection + Saline infusion (SAL-SAL)
Saline subcutaneous injection, Intravenous saline infusion (NaCl (9 mg/ml))
Other: Saline infusion
Saline/NaCl (9mg/ml) intravenous infusion
Other: Saline injection
Saline/NaCl (9mg/ml) subcutaneous injection
Active Comparator: GLP-2 agonist injection + Saline infusion (AGO-SAL)
Subcutaneous injection of GLP-2 (1-33) agonist, Intravenous infusion of saline (NaCl (9 mg/ml))
Other: Saline infusion
Saline/NaCl (9mg/ml) intravenous infusion
Other: Agonist injection
GLP-2(1-33) subcutaneous injection
Experimental: GLP-2 agonist injection + GLP-2 1 nmol antagonist infusion (AGO-1ANT)
Subcutaneous Injection of GLP-2 (1-33) agonist, Intravenous infusion of 1 nmol/kg/min GLP-2 (3-33) antagonist
Other: Agonist injection
GLP-2(1-33) subcutaneous injection
Other: 1nmol antagonist infusion
GLP-2 (1-33)/GLP-2(3-33) 1 nmol/kg/min
Experimental: GLP-2 agonist injection + GLP-2 4 nmol antagonist infusion (AGO-4ANT)
Subcutaneous Injection of GLP-2 (1-33) agonist, Intravenous infusion of 4 nmol/kg/min GLP-2 (3-33) antagonist
Other: Agonist injection
GLP-2(1-33) subcutaneous injection
Other: 4 nmol antagonist infusion
GLP-2 (1-33)/GLP-2 (3-33) 4 nmol/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SMA blood flow
Time Frame: 85 minutes
Blood flow in the superior mesenteric artery
85 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PVblood flow
Time Frame: 85 minutes
Blood flow in the portal vein
85 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 7, 2024

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-24000668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be shared upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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