DelfaGLP-1 Atlas

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UnknownPhase NA

A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide

A Pilot Study of the fMRI Response to Leptin and Pramlintide

Asset

Pramlintide

Intravenous · Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

10

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•FMRI response in the hypothalamus and brainstem, and whole brain

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00691158
Org study IDeIRB #2168
Secondary IDOCTRI #933Oregon Health and Sciences University

Timeline

Milestones

Study first posted2008-06-05estimated
Last update posted2022-12-16actual
Study start2006-01 (month precision)
Primary completion2024-07estimated (month precision)
Study completion2024-07estimated (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Age 18 year to 45 years of age
•MI 18 to 25 kg/m2 or ≥ 30 kg/m2
•At maximal lifetime weight
•Weight stable for at least 3 months

Exclusion criteria

•Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
•Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:
–depression
–anorexia
–bulimia
–seizure disorder.
•Exercise > 30 minutes, 3 times a week
•Alcohol consumption > 2 drinks / day
•Weight > 350 lbs (159 kg) (weight limit for MR machine)
•Illicit drug use
•Pregnancy
•Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes
•Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
•Those with claustrophobia
•Anaphylaxis and known hypersensitivity to E. coli-derived proteins
•Allergies or contraindications to metreleptin or pramlintide
•Renal or hepatic impairment
•Women who are lactating
•Tobacco use

Endpoints (2)

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

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.

Time frame:over 90 minutes

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.

Time frame:over 90 minutes

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.