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

What Was Tested

In this phase 2 trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).

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

It had two arms (groups): Pramlintide Acetate (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 400 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: 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.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Amylin (Islet Amyloid Polypeptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2005-05 with completion listed for 2005-11.

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: 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).

It also tracked 1 secondary outcome, for example To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 400 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.