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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189514

Enrollment

210

Registered

2005-09-19

Start date

2005-09-30

Completion date

2007-06-30

Last updated

2015-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, weight loss, Amylin, pramlintide

Brief summary

This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Interventions

DRUGpramlintide acetate

Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg

DRUGplacebo

subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Subject has completed Protocol 137OB-201.

Design outcomes

Primary

Measure	Time frame
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.	open ended
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.	open ended

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026