A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

What Was Tested

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

This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.

It had four arms (groups): Placebo and Metreleptin (experimental), Pramlintide Acetate and Placebo (experimental), Pramlintide Acetate and Metreleptin (experimental) and Lead-In Period (other).

The registry classes the interventions as drug.

Who Took Part

177 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Is a nonsmoker (has not smoked for at least 6 months prior to the study). Consumes a morning and evening meal each day.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: is diagnosed with type 2 diabetes; has previously received treatment with recombinant leptin or pramlintide.

How the Study Was Run

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

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.

As a double-blind Amylin (Islet Amyloid Polypeptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-10 with completion listed for 2007-09.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population (time frame: Baseline to Week 16).

It also tracked 25 secondary outcomes, for example LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population, LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population, LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population, LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population, Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population and LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 177 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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