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NCT00189514·Phase 2·INTERVENTIONAL

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

PramlintideWeight lossCompleted

Status

Completed

Phase

Phase 2

Enrollment

210

Locations

21

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

pramlintide acetate

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

DRUG

placebo

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

Timeline

From registration to results.

  1. First posted

    Sep 19, 2005

  2. Study start

    Sep 2005

  3. Primary completion

    Jun 2007

  4. Study completion

    Jun 2007

  5. Results posted

    Not reported

  6. Registry updated

    Jun 11, 2015

Outcomes

What the study measures.

Primary outcomes

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

Time frame · open ended

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

Time frame · open ended

Secondary outcomes

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

Time frame · open ended

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Subject has completed Protocol 137OB-201.

Study locations

21 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Chula Vista, California, United States

Research Site

San Diego, California, United States

Research Site

Walnut Creek, California, United States

Research Site

Miami, Florida, United States

Research Site

Augusta, Georgia, United States

Research Site

Chicago, Illinois, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Overland Park, Kansas, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

Detroit, Michigan, United States

Research Site

Edina, Minnesota, United States

Research Site

St Louis, Missouri, United States

Research Site

Butte, Montana, United States

Research Site

New York, New York, United States

Research Site

Cincinnati, Ohio, United States

Research Site

Portland, Oregon, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Austin, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Olympia, Washington, United States

Publications

Results and literature.

PMID 18753666 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsPramlintide trial dashboard →