NCT00189514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 11, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

September 12, 2005

Last Update Submit

June 10, 2015

Conditions

Obesity

Keywords

obesityweight lossAmylinpramlintide

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    open ended

Study Arms (4)

1

EXPERIMENTAL
Drug: pramlintide acetate

2

EXPERIMENTAL
Drug: pramlintide acetate

3

EXPERIMENTAL
Drug: pramlintide acetate

4

PLACEBO COMPARATOR
Drug: placebo

Interventions

pramlintide acetateDRUG

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

Also known as: Symlin
123
placeboDRUG

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

4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has completed Protocol 137OB-201.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Chula Vista, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

Walnut Creek, California, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Augusta, Georgia, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Indianapolis, Indiana, United States

Location

Research Site

Overland Park, Kansas, United States

Location

Research Site

Baton Rouge, Louisiana, United States

Location

Research Site

Detroit, Michigan, United States

Location

Research Site

Edina, Minnesota, United States

Location

Research Site

St Louis, Missouri, United States

Location

Research Site

Butte, Montana, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Austin, Texas, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

Olympia, Washington, United States

Location

Related Publications (1)

  • Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20.

    PMID: 18753666DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

pramlintide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Lisa Porter, MD

    Amylin Pharmaceuticals, LLC.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 11, 2015

Record last verified: 2015-05

Locations

US(21)