HealthyGLP-2antNCT06774807
Blocking of the Gut Hormone Receptor for Glucagon-like Peptide 2 (GLP-2) by the GLP-2 Receptor Antagonist GLP-2(3-33)
A study testing Saline infusion, Saline injection and 1nmol antagonist infusion in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saline infusion, Saline injection and 1nmol antagonist infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2024to 7 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- BMI 19-28 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Saline infusion, Saline injection, 1nmol antagonist infusion, 4 nmol antagonist infusion, Agonist injection
- Keywords
- Glucagon-Like Peptide 2, GLP-2, GLP-2 (3-33), GLP-2 (1-33), Gastrointestinal Blood Flow, Superior Mesenteric Artery, Portal Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline infusionOther
Saline/NaCl (9mg/ml) intravenous infusion
Saline injectionOther
Saline/NaCl (9mg/ml) subcutaneous injection
1nmol antagonist infusionOther
GLP-2 (1-33)/GLP-2(3-33) 1 nmol/kg/min
4 nmol antagonist infusionOther
GLP-2 (1-33)/GLP-2 (3-33) 4 nmol/kg/min
Agonist injectionOther
GLP-2(1-33) subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Saline injection + Saline infusion (SAL-SAL) | Placebo comparator | Saline subcutaneous injection, Intravenous saline infusion (NaCl (9 mg/ml)) Receives: 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)) Receives: 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 Receives: 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 Receives: Other: 4 nmol antagonist infusion; Other: Agonist injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SMA blood flow
Blood flow in the superior mesenteric artery
Measured: 85 minutes
Secondary outcomes (1)
PVblood flow
Blood flow in the portal vein
Measured: 85 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion7 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, placebo-controlled, single-blinded, crossover-study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774807
- Sponsor's protocol ID
- H-24000668
- Acronym
- GLP-2ant
- Status last verified
- Apr 2025
- First submitted
- 7 Jan 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be shared upon request
Publications
Gasbjerg LS, Ostergaard FH, Rasmussen RS, Langberg LS, Nielsen SW, Alstrup L, Larsson TSW, Andersen UB, Larsson HBW, Asmar A, Haddock B, Vestergaard MB. Reproducibility of Splanchnic Blood Flow Measured Using Phase-Contrast MRI. NMR Biomed. 2026 Aug;39(8):e70348. doi: 10.1002/nbm.70348.
PubMed 42373095
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antagonist of the Glucagon-like Peptide 2 (GLP-2) Receptor
- ClinicalTrials.gov ID
- NCT06774807
- Acronym / sponsor ID
- GLP-2ant / H-24000668
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 7 Sep 2024 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomised, placebo-controlled, single-blinded, crossover-study
| Arm | Type | Receives |
|---|---|---|
| Saline injection + Saline infusion (SAL-SAL) | Placebo comparator | Other: Saline infusion, Other: Saline injectionSaline subcutaneous injection, Intravenous saline infusion (NaCl (9 mg/ml)) |
| GLP-2 agonist injection + Saline infusion (AGO-SAL) | Active comparator | Other: Saline infusion, Other: Agonist injectionSubcutaneous injection of GLP-2 (1-33) agonist, Intravenous infusion of saline (NaCl (9 mg/ml)) |
| GLP-2 agonist injection + GLP-2 1 nmol antagonist infusion (AGO-1ANT) | Experimental | Other: 1nmol antagonist infusion, Other: Agonist injectionSubcutaneous Injection of GLP-2 (1-33) agonist, Intravenous infusion of 1 nmol/kg/min GLP-2 (3-33) antagonist |
| GLP-2 agonist injection + GLP-2 4 nmol antagonist infusion (AGO-4ANT) | Experimental | Other: 4 nmol antagonist infusion, Other: Agonist injectionSubcutaneous Injection of GLP-2 (1-33) agonist, Intravenous infusion of 4 nmol/kg/min GLP-2 (3-33) antagonist |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70 years
- BMI 19-28 kg/m2
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline infusionSaline/NaCl (9mg/ml) intravenous infusion | Other | GLP-2 agonist injection + Saline infusion (AGO-SAL), Saline injection + Saline infusion (SAL-SAL) |
| Saline injectionSaline/NaCl (9mg/ml) subcutaneous injection | Other | Saline injection + Saline infusion (SAL-SAL) |
| 1nmol antagonist infusionGLP-2 (1-33)/GLP-2(3-33) 1 nmol/kg/min | Other | GLP-2 agonist injection + GLP-2 1 nmol antagonist infusion (AGO-1ANT) |
| 4 nmol antagonist infusionGLP-2 (1-33)/GLP-2 (3-33) 4 nmol/kg/min | Other | GLP-2 agonist injection + GLP-2 4 nmol antagonist infusion (AGO-4ANT) |
| Agonist injectionGLP-2(1-33) subcutaneous injection | Other | 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) |
Primary outcome
SMA blood flow
Time frame: 85 minutes
Blood flow in the superior mesenteric artery
1 secondary outcome
PVblood flow
Time frame: 85 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Derived from this study: PubMed 42373095Gasbjerg LS, Ostergaard FH, Rasmussen RS, Langberg LS, Nielsen SW, Alstrup L, Larsson TSW, Andersen UB, Larsson HBW, Asmar A, Haddock B, Vestergaard MB. Reproducibility of Splanchnic Blood Flow Measured Using Phase-Contrast MRI. NMR Biomed. 2026 Aug;39(8):e70348. doi: 10.1002/nbm.70348.
- Individual participant dataSharing planned: Yes. Will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline infusion, Saline injection and 1nmol antagonist infusion in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMA blood flow (time frame: 85 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.