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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT00112021 (opens ClinicalTrials.gov in a new tab)Other id137OB-201
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
May 2005
Primary completion
Nov 2005
Completion
Nov 2005
First posted
30 May 2005 (estimated)
Last update posted
10 Apr 2015 (estimated)
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006
  1. Ph 2

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

    NCT00112021

    May 2005 to Nov 2005

Registry summary

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

This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Interventions

  • pramlintide acetateDrug

Arms2

  • Experimental

    Pramlintide Acetate

  • Placebo comparator

    Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Approximately 16 weeks

  2. To examine the safety and tolerability of pramlintide in obese subjects

    Time frame · Approximately 16 weeks

Secondary outcomes(1)

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

    Time frame · Approximately 16 weeks

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: * 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.

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