Skip to main content
Delfa

← All trials/NCT00112021

CompletedPhase 2

A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

A Phase 2B, Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging, Multicenter Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Lead sponsor

AstraZeneca

Asset

Pramlintide

Amylin analog

Listed sites

21

Recruiting sites

-

Actual enrollment

400

Study population

Obesity / overweight

Eligibility highlights

•BMI 30-50

Primary endpoints

•Effect of pramlintide on body weight in obese subjects•Safety and tolerability of pramlintide in obese subjects

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 IDNCT00112021
Org study ID137OB-201

Timeline

Milestones

Study first posted2005-05-30estimated
Last update posted2015-04-10estimated
Study start2005-05 (month precision)
Primary completion2005-11actual (month precision)
Study completion2005-11actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening.
•Usually consumes at least three major meals (morning, midday, and evening) each day.

Exclusion criteria

•Is currently enrolled in a formal weight-loss program.
•Has had liposuction within 1 year before screening or is planning to have liposuction during the study.
•Has received any investigational drug within 3 months before screening.
•Has previously participated in a study using pramlintide.

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

Weight & body composition
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

To examine the effect of pramlintide on body weight in obese subjects

Time frame:Approximately 16 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

To examine the safety and tolerability of pramlintide in obese subjects

Time frame:Approximately 16 weeks

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters

Time frame:Approximately 16 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.