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

NCT ID: NCT06774807

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-09-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised, placebo-controlled, single-blinded, crossover-study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Saline injection + Saline infusion (SAL-SAL)

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

Group Type PLACEBO_COMPARATOR

Saline infusion

Intervention Type OTHER

Saline/NaCl (9mg/ml) intravenous infusion

Saline injection

Intervention Type OTHER

Saline/NaCl (9mg/ml) subcutaneous injection

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

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

Group Type ACTIVE_COMPARATOR

Saline infusion

Intervention Type OTHER

Saline/NaCl (9mg/ml) intravenous infusion

Agonist injection

Intervention Type OTHER

GLP-2(1-33) subcutaneous injection

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

Group Type EXPERIMENTAL

1nmol antagonist infusion

Intervention Type OTHER

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

Agonist injection

Intervention Type OTHER

GLP-2(1-33) subcutaneous injection

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

Group Type EXPERIMENTAL

4 nmol antagonist infusion

Intervention Type OTHER

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

Agonist injection

Intervention Type OTHER

GLP-2(1-33) subcutaneous injection

Interventions

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Saline infusion

Saline/NaCl (9mg/ml) intravenous infusion

Intervention Type OTHER

Saline injection

Saline/NaCl (9mg/ml) subcutaneous injection

Intervention Type OTHER

1nmol antagonist infusion

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

Intervention Type OTHER

4 nmol antagonist infusion

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

Intervention Type OTHER

Agonist injection

GLP-2(1-33) subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H-24000668

Identifier Type: -

Identifier Source: org_study_id

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