ObesityNCT07854886
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
A study testing Gastric glucose, GLP-1(7-36)NH2 and Exendin(9-39)NH2 in people with Obesity and Normal Weight, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to learn how the gut hormone glucagon-like peptide-1 (GLP-1) helps the brain sense sugar. It includes adults with healthy weight and adults with obesity. The main questions this trial aims to answer are: A. Does GLP-1 cause the brain's response to sugar? B. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Normal Weight, Glucose Intolerance
- What is being tested?
- Gastric glucose, GLP-1(7-36)NH2 and Exendin(9-39)NH2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1:
- Age 18-75 years
- BMI 18.5-25 kg/m²
- Normal glucose tolerance (Fasting glucose < 5.6 mmol/L)
- Group 2:
- Age and sex-matched with group 1
- BMI≥30 kg/m²
- Impaired glucose tolerance (Fasting glucose 5.6 - 6.9 mmol/L)
Who cannot join
- Diabetes mellitus type 1 or type 2, or fasting plasma glucose > 7.0 mmol/L
- Treatment with GLP-1 receptor agonists or other GLP-1-based therapies within the past three months
- Use of medication affecting appetite, body weight, or glucose metabolism within the past three months
- Current eating disorder (anorexia nervosa, bulimia nervosa)
- Known serious chronic disease, including but not limited to:
- Heart disease
Show all 25Show fewer
- Anemia (hemoglobin <7.0 mmol/L for women, <8.0 mmol/L for men)
- Renal impairment (eGFR <60 mL/min/1.73m²)
- Hepatic impairment (ALT or AST >3 times upper limit of normal)
- Known monogenic obesity
- Substance abuse (current or within the past year)
- Previous bariatric surgery
- Contraindications to study procedures, including:
- Esophageal or nasal obstruction (e.g. tumors, strictures)
- Coagulopathy
- History of skull base trauma
- Esophageal varices
- Hiatal hernia
- Claustrophobia
- Inability to comply with MRI requirements (e.g. remaining still)
- Presence of non-removable magnetic objects incompatible with MRI
- Any other condition or circumstance that, in the opinion of the study physician, may compromise safe participation in the study.
- Pregnancy, breastfeeding, or wish to become pregnant during the study period
- Women of childbearing potential not using adequate contraception
- Women using hormonal contraception (oral contraceptives, progestin- containing implants or hormonal intrauterine device.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, 2200
Sarah Byberg, MD, PhD
About this study
Official title: Quantifying Hypothalamic GLP-1 Response in Healthy Weight and Obesity: A Randomized Crossover Neuroimaging Infusion Study
The goal of this clinical trial is to learn how the gut hormone glucagon-like peptide-1 (GLP-1) helps the brain sense sugar. It includes adults with healthy weight and adults with obesity.
The main questions this trial aims to answer are:
Read more
- Does GLP-1 cause the brain's response to sugar? B. Do lower GLP-1 levels cause a weaker brain response to sugar in adults with obesity?
Researchers will compare each participant's brain response across four test days. On these days, GLP-1 levels will be blocked, raised, or left unchanged. Sugar will be given either into the stomach or into a vein.
Participants will:
Attend 1 screening visit Visit the clinic for 4 test days Receive sugar and get an MRI scan of their brain on each test day
- Conditions
- Obesity, Normal Weight, Glucose Intolerance
- Being tested
- Gastric glucose, GLP-1(7-36)NH2, Exendin(9-39)NH2, Isoglycemic intravenous glucose infusion
- Keywords
- GLP-1, Hypothalamus, Obesity
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric glucoseOther
Gastric glucose administration with intravenous saline infusion.
GLP-1(7-36)NH2Other
GLP-1(7-36)NH2 infusion with gastric glucose administration.
Exendin(9-39)NH2Other
Exendin(9-39)NH2 infusion with gastric glucose administration.
Isoglycemic intravenous glucose infusionOther
Glucose infusion with rate adjustment to replicate the individual plasma glucose excursion observed during gastric glucose administration on test day 1.
| Study group | Role | What they receive |
|---|---|---|
| Healthy weight | Experimental | Each participant completes all four experimental conditions. Gastric glucose administration is conducted on the first test day; the following three test days are performed in randomized order. Receives: Other: Gastric glucose; Other: GLP-1(7-36)NH2; Other: Exendin(9-39)NH2; Other: Isoglycemic intravenous glucose infusion |
| Obesity | Experimental | Each participant completes all four experimental conditions. Gastric glucose administration is conducted on the first test day; the following three test days are performed in randomized order. Receives: Other: Gastric glucose; Other: GLP-1(7-36)NH2; Other: Exendin(9-39)NH2; Other: Isoglycemic intravenous glucose infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline
Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.
Measured: During the MRI scan on three test days
Hypothalamic response to glucose ingestion during GLP-1 infusion compared with saline
Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.
Measured: During the MRI scan on three test days
Secondary outcomes (7)
Ad libitum energy intake
Energy intake at an ad libitum meal, recorded as an objective measure of satiety, reported as the difference between conditions within each group.
Measured: After the MRI scan on four test days
Subjective appetite sensations
Appetite sensations rated on visual analogue scales (0-100 mm; higher scores indicate a stronger sensation), reported as the difference between conditions within each group.
Measured: Immediately before and immediately after the MRI scan on four test days
T2 relaxation time in the mediobasal hypothalamus
T2 relaxation time is measured in the mediobasal hypothalamus using a T2-weighted sequence previously validated for quantification of hypothalamic gliosis. Longer T2 relaxation time indicates greater gliosis.
Measured: During the MRI scan on one of four test day
Plasma glucose concentration
Glucose concentration (mmol/L) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.
Measured: Fasting baseline and during the MRI scan on four test days
Plasma GLP-1 concentration
GLP-1 concentration (pmol/L) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.
Measured: Fasting baseline and during the MRI scan on four test days
Plasma insulin concentration
Insulin concentration (pmol/L) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.
Measured: Fasting baseline and during the MRI scan on four test days
Plasma C-peptide concentration
C-peptide concentration (pmol/L) measured in plasma at fasting baseline and at repeated time points during the MRI scan on each test day. Concentrations are reported for each group and compared between groups.
Measured: Fasting baseline and during the MRI scan on four test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Participants are assigned to one of two groups according to body mass index: healthy weight, or obesity, matched by age and sex. Each participant completes all four experimental conditions; randomization applies to the order of test days 2 to 4 within each participant.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Sarah Byberg, University of Copenhagen
- Investigators
- Sarah Byberg, MD, PhD, Principal investigator, University of Copenhagen, Department of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854886
- Sponsor's protocol ID
- H-26002300
- Other IDs
- 5283-00538B, 101212194
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be in accordance with EU and General Data Protection Regulation requirements and applicable local regulations, and in accordance with trial protocol and statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Hypothalamic GLP-1 Response in Healthy Weight and Obesity: A Randomized Crossover Neuroimaging Infusion Study
- ClinicalTrials.gov ID
- NCT07854886
- Acronym / sponsor ID
- H-26002300
- Conditions
- Obesity, Normal Weight, Glucose Intolerance
- Keywords
- GLP-1, Hypothalamus, Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Oct 2026 (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.
The goal of this clinical trial is to learn how the gut hormone glucagon-like peptide-1 (GLP-1) helps the brain sense sugar. It includes adults with healthy weight and adults with obesity.
The main questions this trial aims to answer are:
- Does GLP-1 cause the brain's response to sugar? B. Do lower GLP-1 levels cause a weaker brain response to sugar in adults with obesity?
Researchers will compare each participant's brain response across four test days. On these days, GLP-1 levels will be blocked, raised, or left unchanged. Sugar will be given either into the stomach or into a vein.
Participants will:
Attend 1 screening visit Visit the clinic for 4 test days Receive sugar and get an MRI scan of their brain on each test day
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups according to body mass index: healthy weight, or obesity, matched by age and sex. Each participant completes all four experimental conditions; randomization applies to the order of test days 2 to 4 within each participant.
| Arm | Type | Receives |
|---|---|---|
| Healthy weight | Experimental | Other: Gastric glucose, Other: GLP-1(7-36)NH2, Other: Exendin(9-39)NH2, Other: Isoglycemic intravenous glucose infusionEach participant completes all four experimental conditions. Gastric glucose administration is conducted on the first test day; the following three test days are performed in randomized order. |
| Obesity | Experimental | Other: Gastric glucose, Other: GLP-1(7-36)NH2, Other: Exendin(9-39)NH2, Other: Isoglycemic intravenous glucose infusionEach participant completes all four experimental conditions. Gastric glucose administration is conducted on the first test day; the following three test days are performed in randomized order. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years
- BMI 18.5-25 kg/m²
- Normal glucose tolerance (Fasting glucose < 5.6 mmol/L)
- Age and sex-matched with group 1
- BMI≥30 kg/m²
Key exclusion criteria (25 listed)
- Diabetes mellitus type 1 or type 2, or fasting plasma glucose > 7.0 mmol/L
- Treatment with GLP-1 receptor agonists or other GLP-1-based therapies within the past three months
- Use of medication affecting appetite, body weight, or glucose metabolism within the past three months
- Current eating disorder (anorexia nervosa, bulimia nervosa)
- Known serious chronic disease, including but not limited to:
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 |
|---|---|---|
| Gastric glucoseGastric glucose administration with intravenous saline infusion. | Other | Healthy weight, Obesity |
| GLP-1(7-36)NH2GLP-1(7-36)NH2 infusion with gastric glucose administration. | Other | Healthy weight, Obesity |
| Exendin(9-39)NH2Exendin(9-39)NH2 infusion with gastric glucose administration. | Other | Healthy weight, Obesity |
| Isoglycemic intravenous glucose infusionGlucose infusion with rate adjustment to replicate the individual plasma glucose excursion observed during gastric glucose administration on test day 1. | Other | Healthy weight, Obesity |
Primary outcome
Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline
Time frame: During the MRI scan on three test days
Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.
Hypothalamic response to glucose ingestion during GLP-1 infusion compared with saline
Time frame: During the MRI scan on three test days
Blood oxygen level-dependent (BOLD) time series are extracted from the hypothalamus and expressed relative to the BOLD signal during fasting. The hypothalamic response to glucose ingestion is defined as the relative difference between the gastric glucose condition and the isoglycemic intravenous glucose condition, pre-specified as the net area under the curve (netAUC). This outcome is reported as the difference between conditions in each group, and compared between groups.
7 secondary outcomes
Ad libitum energy intake
Time frame: After the MRI scan on four test days
Subjective appetite sensations
Time frame: Immediately before and immediately after the MRI scan on four test days
T2 relaxation time in the mediobasal hypothalamus
Time frame: During the MRI scan on one of four test day
Plasma glucose concentration
Time frame: Fasting baseline and during the MRI scan on four test days
Plasma GLP-1 concentration
Time frame: Fasting baseline and during the MRI scan on four test days
Plasma insulin concentration
Time frame: Fasting baseline and during the MRI scan on four test days
Plasma C-peptide concentration
Time frame: Fasting baseline and during the MRI scan on four test days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Data sharing will be in accordance with EU and General Data Protection Regulation requirements and applicable local regulations, and in accordance with trial protocol and statistical analysis plan.
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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.
Sarah Byberg, MD, PhD principal investigator
University of Copenhagen, Department of Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric glucose, GLP-1(7-36)NH2 and Exendin(9-39)NH2 in people with Obesity and Normal Weight, 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 8 inclusion and 25 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: opening soon, as of the sponsor's last update on 2 Oct 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Byberg, MD (+45 50247452, sarah.byberg@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline (time frame: During the MRI scan on three test days). 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?
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 Oct 2026.