Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects

What Was Tested

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

The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.

It had 1 arm (groups): Pramlintide acetate (AC137) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 184 actual participants took part.

It was open to people of any sex aged from 25 years up to 60 years.

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

Examples of who could join: Is \<6'3" (190.5 cm) tall and weighs \<300 lb (\~136.3 kg). Is a nonsmoker (never smoked or has not smoked for at least 2 years). Does not have a clinical diagnosis of diabetes. Has not had a major change in daily physical activity within 2 months prior to study start (e.g., initiation of an exercise program). Usually consumes three major meals (morning, midday, and evening) each day and rarely (less than once a week) wakes up to eat during the night.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: is currently enrolled in a weight loss program or plans to enroll in a weight loss or exercise program within the next 3 months; is currently treated or expected to require or undergo treatment or has been treated within 2 months before screening with medications that are excluded:; systemic steroids by oral, intravenous, or intramuscular route or potent topical steroids that are known to result in high systemic absorption.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2004-08 with completion listed for 2005-05.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example To evaluate the safety and tolerability of SC infused or injected pramlintide in obese subjects.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 184 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.