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

Plain-language guide to NCT00189514: phase 2 randomized trial of Amylin (Islet Amyloid Polypeptide), 210 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00189514
Phase: phase 2
Status: completed
Start: 2005-09
Completion (planned or actual): 2007-06
Participants: 210 (actual)
Design: randomized, double-blind, treatment
Conditions studied: Obesity
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Amylin (Islet Amyloid Polypeptide).

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.

It had four arms (groups): 1 (experimental), 2 (experimental), 3 (experimental) and 4 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 210 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subject has completed Protocol 137OB-201.

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

The Amylin (Islet Amyloid Polypeptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Amylin (Islet Amyloid Polypeptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2005-09 with completion listed for 2007-06.

It ran at 21 sites in United States (21).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 210 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.

Our Notes on the Compound

Amylin (Islet Amyloid Polypeptide): A 37-amino-acid hormone released with insulin that slows stomach emptying and signals fullness; pramlintide (Symlin) is a synthetic version.

Amylin (Islet Amyloid Polypeptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.