Incretin EffectH-21044858NCT06194955

The Effect of GIP, GLP-1 and GLP-2 in Individuals With Genetically Altered Receptor Function

A study testing GIP(1-42), GLP-1 and GLP-2 in people with Incretin Effect, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This project will characterize the physiological effect of the hormones, GIP-, GLP-1- and GLP-2 infusions in a group of individuals that are carriers of GIP-, GLP-1- and GLP-2 receptor gene variants, respectively. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Incretin Effect
What is being tested?: GIP(1-42), GLP-1 and GLP-2
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteDenmark
Study dates: 4 Jan 2023to 1 Apr 2026
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI 19-35 kg/m2

Who cannot join

Treatment with medication or supplements that can not be discontinued for 12 hours
>10 objects of alcohol weekly or abuse of narcotics
Liver disease (defined as ALAT and/or ASAT ≥ 2 x normal levels)
Decreased kidney function (creatine levels over reference interval)
Uncontrollable increased blood pressure (> 140/90 mmHg)
Low blood percentage (hemoglobin < 8.3 mmol/l)
Special diet or planned weight change during trial period
Other conditions that could be expected to affect the primary or secondary outcomes

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900

Other trials in Denmark

About this study

Official title: The Effect of Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon-like Peptide-1 (GLP-1) and Glucagon-like Peptide-2 (GLP-2) in Individuals With Genetically Altered Receptor Function

Read the detailed description

Participants with mutations in their GLP-1- and GIP receptor will attend five randomized experimental days, A1, A2, B, C and D. On day A1 an oral glucose tolerance test (OGTT) will be performed, and on day A2, an intravenous isoglycaemic glucose infusion (IIGI) will be performed. On experimental day B and C, the study participants will receive GLP-1 and GIP hormones, respectively, under stable glucose infusions and on experimental day D, they will receive infusion of salt water (placebo) under stable glucose infusion.

Participants with mutations in their GLP-2 receptor will attend three randomized experimental days, E, F and G. A mixed meal test (MMT) will be performed on day E, an infusion with GLP-2 during fasting blood glucose levels will be performed on day F, and infusion with salt water (placebo) during fasting blood glucose levels will be performed on day G.

Additionally, a DXA scan and arginine test will be performed on all study participants.

Conditions: Incretin Effect
Being tested: GIP(1-42), GLP-1, GLP-2, Placebo
Keywords: Gut hormones, single nucleotide variants (SNVs), GIP, GLP-1, GLP-2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GIP(1-42)Drug
Infusion
GLP-1Drug
Infusion
GLP-2Drug
Infusion
PlaceboOther
Saline

Study groups in NCT06194955
Study group	Role	What they receive
GIPR variant carriers	Active comparator	Inidividuals with GIPR variants: Determination of the incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp. Receives: Drug: GIP(1-42); Drug: GLP-1; Other: Placebo
GIPR variant carrier controls	Placebo comparator	Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp. Receives: Drug: GIP(1-42); Drug: GLP-1; Other: Placebo
GLP-1R variant carrier	Active comparator	Individuals with GLP-1R variants: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp Receives: Drug: GIP(1-42); Drug: GLP-1; Other: Placebo
GLP-1R variant carrier controls	Placebo comparator	Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of to GIP and GLP-1 infusions during hyperglycemic clamp. Receives: Drug: GIP(1-42); Drug: GLP-1; Other: Placebo
GLP-2R variant carrier	Active comparator	Individuals with GLP-2R variants: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels Receives: Drug: GLP-2; Other: Placebo
GLP-2R variant carrier control	Placebo comparator	Healthy matched individuals: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels Receives: Drug: GLP-2; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide)
Blood sample
Measured: 240 minutes
For GLP-2 receptor variants: CTX (bone resorption marker)
Blood sample
Measured: 120 minutes

Secondary outcomes (8)

GIP levels
Blood sample
Measured: 240 minutes
GLP-1 levels
Blood sample
Measured: 240 minutes
GLP-2 levels
Blood sample
Measured: 240 minutes
CTX (bone resorption marker)
Blood sample
Measured: 240 minutes
P1NP (bone formation marker)
Blood Sample
Measured: 240 minutes
Heart rate
Beats/minute
Measured: 240 minutes
Insulin
Blood sample
Measured: 240 minutes
Glucagon
Blood sample
Measured: 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 20231 Apr 2026

First posted8 Jan 2024
Study start4 Jan 2023
Primary completion10 Dec 2025
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Incretin EffectStudies 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: Single-blind, randomized, crossover study
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06194955
Sponsor's protocol ID: H-21044858
Acronym: H-21044858
Status last verified: Apr 2026
First submitted: 22 Dec 2023
Last updated: 29 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Incretin Effect trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon-like Peptide-1 (GLP-1) and Glucagon-like Peptide-2 (GLP-2) in Individuals With Genetically Altered Receptor Function
ClinicalTrials.gov ID: NCT06194955
Acronym / sponsor ID: H-21044858 / H-21044858
Conditions: Incretin Effect
Keywords: Gut hormones, single nucleotide variants (SNVs), GIP, GLP-1, GLP-2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of CopenhagenUniversity, hospital or other
Collaborators: Gentofte Hospital, Denmark
Study start: 4 Jan 2023 (actual)
Primary completion: 10 Dec 2025 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 8 Jan 2024 (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.

Detailed description

Additionally, a DXA scan and arginine test will be performed on all study participants.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6
Model description: Single-blind, randomized, crossover study

Arm	Type	Receives
GIPR variant carriers	Active comparator	Drug: GIP(1-42), Drug: GLP-1, Other: PlaceboInidividuals with GIPR variants: Determination of the incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp.
GIPR variant carrier controls	Placebo comparator	Drug: GIP(1-42), Drug: GLP-1, Other: PlaceboHealthy matched individuals: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp.
GLP-1R variant carrier	Active comparator	Drug: GIP(1-42), Drug: GLP-1, Other: PlaceboIndividuals with GLP-1R variants: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp
GLP-1R variant carrier controls	Placebo comparator	Drug: GIP(1-42), Drug: GLP-1, Other: PlaceboHealthy matched individuals: Determination of incretin effect, and the insulinotropic actions of to GIP and GLP-1 infusions during hyperglycemic clamp.
GLP-2R variant carrier	Active comparator	Drug: GLP-2, Other: PlaceboIndividuals with GLP-2R variants: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels
GLP-2R variant carrier control	Placebo comparator	Drug: GLP-2, Other: PlaceboHealthy matched individuals: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

BMI 19-35 kg/m2

Key exclusion criteria (8 listed)

Treatment with medication or supplements that can not be discontinued for 12 hours
>10 objects of alcohol weekly or abuse of narcotics
Liver disease (defined as ALAT and/or ASAT ≥ 2 x normal levels)
Decreased kidney function (creatine levels over reference interval)
Uncontrollable increased blood pressure (> 140/90 mmHg)

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
GIP(1-42)Infusion	Drug	GIPR variant carrier controls, GIPR variant carriers, GLP-1R variant carrier, GLP-1R variant carrier controls
GLP-1Infusion	Drug	GIPR variant carrier controls, GIPR variant carriers, GLP-1R variant carrier, GLP-1R variant carrier controls
GLP-2Infusion	Drug	GLP-2R variant carrier, GLP-2R variant carrier control
PlaceboSaline	Other	GIPR variant carrier controls, GIPR variant carriers, GLP-1R variant carrier, GLP-1R variant carrier controls, GLP-2R variant carrier, GLP-2R variant carrier control

Primary outcome

For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide)
Time frame: 240 minutes
Blood sample
For GLP-2 receptor variants: CTX (bone resorption marker)
Time frame: 120 minutes
Blood sample

8 secondary outcomes

GIP levels
Time frame: 240 minutes
GLP-1 levels
Time frame: 240 minutes
GLP-2 levels
Time frame: 240 minutes
CTX (bone resorption marker)
Time frame: 240 minutes
P1NP (bone formation marker)
Time frame: 240 minutes
Heart rate
Time frame: 240 minutes
Insulin
Time frame: 240 minutes
Glucagon
Time frame: 240 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 29 Apr 2026.
Individual participant dataSharing planned: Yes

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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 GIP(1-42), GLP-1 and GLP-2 in people with Incretin Effect, 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 1 inclusion and 8 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 29 Apr 2026. 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?

For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide) (time frame: 240 minutes). The study lists 2 primary outcomes in all. 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 NCT06194955.

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 29 Apr 2026.