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NCT00112021·Phase 2·INTERVENTIONAL

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

PramlintideWeight lossCompleted

Status

Completed

Phase

Phase 2

Enrollment

400

Locations

21

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This is a study 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

Timeline

From registration to results.

  1. First posted

    May 30, 2005

  2. Study start

    May 2005

  3. Primary completion

    Nov 2005

  4. Study completion

    Nov 2005

  5. Results posted

    Not reported

  6. Registry updated

    Apr 10, 2015

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Approximately 16 weeks

To examine the safety and tolerability of pramlintide in obese subjects

Time frame · Approximately 16 weeks

Secondary outcomes

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

Time frame · Approximately 16 weeks

Eligibility

Who can take part.

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

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.

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.

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TrialsPramlintide trial dashboard →