Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

What Was Tested

This registered phase 2 trial tested Amylin (Islet Amyloid Polypeptide).

It had eight arms (groups): Placebo-P + Placebo-M (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

Placebo matched to pramlintide BID plus placebo matched to metreleptin BID.

The registry classes the interventions as drug.

Who Took Part

The registry lists 636 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18 to 65 years old. Is obese (Body Mass Index \[BMI\]\>=30kg/m\^2 and \<=35kg/m\^2); or overweight (BMI\>=27kg/m\^2 and \<30kg/m\^2. Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study. Is a nonsmoker (has not smoked for at least 6 months prior to the study).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (symlin®); has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.

How the Study Was Run

Design: randomized, factorial and double-blind.

Because people in this Amylin (Islet Amyloid Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Amylin (Islet Amyloid Polypeptide).

Those kept unaware of assignments: participant and investigator.

It started in 2008-04 with completion listed for 2009-04.

It ran at 36 sites in United States (36).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population (time frame: Baseline to Week 28).

It also tracked 26 secondary outcomes, for example Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population, LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population, LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population, Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide, Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population and LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 636 people.

With 636 participants it is a large trial for this field.

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.