RecruitingPhase NA

Hypothalamic GLP-1 Response in Healthy Weight and Obesity

Quantifying Hypothalamic GLP-1 Response in Healthy Weight and Obesity: A Randomized Crossover Neuroimaging Infusion Study

Lead sponsor

University of Copenhagen

Asset

Avexitide

GLP-1 receptor antagonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Normal Weight, Obesity / overweight, Prediabetes / glucose intolerance

Eligibility highlights

•BMI 18.5-25

Primary endpoints

•Hypothalamic response to glucose ingestion during GLP-1 receptor blockade•Hypothalamic response to glucose ingestion during GLP-1 infusion

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07854886

Org study IDH-26002300

Secondary ID101212194European Commission (Horizon Europe, MSCA Postdoctoral Fellowship)

Secondary ID5283-00538BDanmarks Frie Forskningsfond (Independent Research Fund Denmark)

Timeline

Milestones

Study start2026-10-01estimated

Study first posted2026-10-02actual

Last update posted2026-11-02actual

Primary completion2028-09-30estimated

Study completion2028-09-30estimated

Assets

Investigational agents

Avexitide

Who this study enrolls

Normal WeightObesity / overweightPrediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

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)

Exclusion criteria

•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

-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.

Exclusion criteria for women:

•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.)

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Hypothalamic response to glucose ingestion during GLP-1 receptor blockade compared with saline

Time frame:During the MRI scan on three test days

descriptive

Primary/protocol endpoint

Hypothalamic response to glucose ingestion during GLP-1 infusion compared with saline

Time frame:During the MRI scan on three test days

descriptive

Secondary/protocol endpoint

Plasma glucose concentration

Time frame:Fasting baseline and during the MRI scan on four test days

concentration, descriptive

Secondary/protocol endpoint

Plasma insulin concentration

Time frame:Fasting baseline and during the MRI scan on four test days

concentration, descriptive

Secondary/protocol endpoint

Plasma C-peptide concentration

Time frame:Fasting baseline and during the MRI scan on four test days

concentration, descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Ad libitum energy intake

Time frame:After the MRI scan on four test days

descriptive

Secondary/protocol endpoint/low confidence

Subjective appetite sensations

Time frame:Immediately before and immediately after the MRI scan on four test days

descriptive

Secondary/protocol endpoint/low confidence

T2 relaxation time in the mediobasal hypothalamus

Time frame:During the MRI scan on one of four test day

descriptive

Secondary/protocol endpoint/low confidence

Plasma GLP-1 concentration

Time frame:Fasting baseline and during the MRI scan on four test days

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.