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CompletedPhase 2

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

Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

21

Recruiting sites

-

Actual enrollment

210

Study population

Obesity / overweight

Eligibility highlights

-

Primary endpoints

•Examine the long-term effect of subcutaneously (SC) injected pramlintide•Examine the long-term safety and tolerability of SC injected 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 IDNCT00189514
Org study ID137OB-201E

Timeline

Milestones

Study first posted2005-09-19estimated
Last update posted2015-06-11estimated
Study start2005-09 (month precision)
Primary completion2007-06actual (month precision)
Study completion2007-06actual (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

Eligibility criteria

•Subject has completed Protocol 137OB-201.

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

Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.

Time frame:open ended

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.

Time frame:open ended

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.

Time frame:open ended

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.