NCT00112021

Brief Summary

This is a study 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
400

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2 obesity

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

May 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

May 27, 2005

Last Update Submit

April 9, 2015

Conditions

Obesity

Keywords

obesityweight lossAmylinpramlintideSymlin

Outcome Measures

Primary Outcomes (2)

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

    Approximately 16 weeks

  • To examine the safety and tolerability of pramlintide in obese subjects

    Approximately 16 weeks

Secondary Outcomes (1)

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

    Approximately 16 weeks

Study Arms (2)

Pramlintide Acetate

EXPERIMENTAL
Drug: pramlintide acetate

Placebo

PLACEBO COMPARATOR

Interventions

pramlintide acetateDRUG
Also known as: Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection
Pramlintide Acetate

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2005

First Posted

May 30, 2005

Study Start

May 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(21)