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

NCT06774807 | Completed

• 1 other identifier: H-24000668
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Glucagon-Like Peptide 2; GLP-2; GLP-2 (3-33); GLP-2 (1-33); Gastrointestinal Blood Flow; Superior Mesenteric Artery; Portal Vein

Outcome Measures

Primary Outcomes (1)

• SMA blood flow

  Blood flow in the superior mesenteric artery

  85 minutes

Secondary Outcomes (1)

• PVblood flow

  85 minutes

Study Arms (4)

Saline injection + Saline infusion (SAL-SAL)

PLACEBO COMPARATOR

Saline subcutaneous injection, Intravenous saline infusion (NaCl (9 mg/ml))

Other: Saline infusion; Other: Saline injection

GLP-2 agonist injection + Saline infusion (AGO-SAL)

ACTIVE COMPARATOR

Subcutaneous injection of GLP-2 (1-33) agonist, Intravenous infusion of saline (NaCl (9 mg/ml))

Other: Saline infusion; Other: Agonist injection

GLP-2 agonist injection + GLP-2 1 nmol antagonist infusion (AGO-1ANT)

EXPERIMENTAL

Subcutaneous Injection of GLP-2 (1-33) agonist, Intravenous infusion of 1 nmol/kg/min GLP-2 (3-33) antagonist

Other: 1nmol antagonist infusion; Other: Agonist injection

GLP-2 agonist injection + GLP-2 4 nmol antagonist infusion (AGO-4ANT)

EXPERIMENTAL

Subcutaneous Injection of GLP-2 (1-33) agonist, Intravenous infusion of 4 nmol/kg/min GLP-2 (3-33) antagonist

Other: 4 nmol antagonist infusion; Other: Agonist injection

Interventions

Saline infusion OTHER

Saline/NaCl (9mg/ml) intravenous infusion

GLP-2 agonist injection + Saline infusion (AGO-SAL); Saline injection + Saline infusion (SAL-SAL)

Saline injection OTHER

Saline/NaCl (9mg/ml) subcutaneous injection

Saline injection + Saline infusion (SAL-SAL)

1nmol antagonist infusion OTHER

GLP-2 (1-33)/GLP-2(3-33) 1 nmol/kg/min

GLP-2 agonist injection + GLP-2 1 nmol antagonist infusion (AGO-1ANT)

4 nmol antagonist infusion OTHER

GLP-2 (1-33)/GLP-2 (3-33) 4 nmol/kg/min

GLP-2 agonist injection + GLP-2 4 nmol antagonist infusion (AGO-4ANT)

Agonist injection OTHER

GLP-2(1-33) subcutaneous injection

GLP-2 agonist injection + GLP-2 1 nmol antagonist infusion (AGO-1ANT); GLP-2 agonist injection + GLP-2 4 nmol antagonist infusion (AGO-4ANT); GLP-2 agonist injection + Saline infusion (AGO-SAL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• BMI 19-28 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, placebo-controlled, single-blinded, crossover-study

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 7, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)