CompletedPhase 2

Evaluation of the Effect of Pramlintide on Satiety and Food Intake

A Single Center, Randomized, Double-blind, Placebo-controlled, Two-period, Crossover Study Evaluating the Acute Effect of Pramlintide on Satiety and Food Intake in Normal-weight and Obese Non-diabetic Subjects and in Insulin Treated Subjects With Type 1 and Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight, Type 1 diabetes, Type 2 diabetes

Eligibility highlights

•BMI 20-25•HbA1c 6.5-10%•Male

Primary endpoints

•Satiety of participants on Pramlintide•Food intake of participants on Pramlintide

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 IDNCT00042601

Org study ID137-149

Timeline

Milestones

Study first posted2002-08-05estimated

Last update posted2015-10-21estimated

Study start2002-07 (month precision)

Primary completion2003-10actual (month precision)

Study completion2003-10actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Healthy volunteersObesity / overweightType 1 diabetesType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexMale

Healthy volunteersNot accepted

Eligibility criteria

For Healthy Volunteers:

•BMI >=20 to <=25kg/m2 or >=30 to <=40 kg/m2

For Subjects with Type 1 or Type 2 Diabetes:

•Treated with insulin for at least 6 months prior to screening

•HbA1c value between 6.5-10% inclusive

•BMI between 20-40kg/m2

Endpoints (3)

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

Other clinical outcomes

Other (unclassified)

Other clinical outcomes

2 endpoints

Primary/protocol endpoint/low confidence

Change in satiety of participants on Pramlintide

Time frame:2 Weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in food intake of participants on Pramlintide

Time frame:2 Weeks

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Effect of pramlintide on postprandial metabolic and hormonal responses

Time frame:2 Weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.