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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT00189514 (opens ClinicalTrials.gov in a new tab)Other id137OB-201E
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
210 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Sept 2005
Primary completion
Jun 2007
Completion
Jun 2007
First posted
19 Sept 2005 (estimated)
Last update posted
11 Jun 2015 (estimated)
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008
  1. Ph 2

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

    NCT00189514

    Sept 2005 to Jun 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • pramlintide acetateDrug
  • placeboDrug

Arms4

  • Experimental

    1

  • Experimental

    2

  • Experimental

    3

  • Placebo comparator

    4

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · open ended

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

    Time frame · open ended

Secondary outcomes(1)

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

    Time frame · open ended

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

10 results

Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.

Smith et al. 2008Diabetes carecited by 135

PMID 18753666PMC2518351DOI 10.2337/dc08-0029PUB-18753666

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subject has completed Protocol 137OB-201.

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