A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

What Was Tested

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

This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and 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

Enrollment: 258 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: Has been obese or overweight for at least one year prior to study start.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: is currently enrolled in or is planning to enroll in a formal weight-loss program; is unwilling or unable to participate in a lifestyle intervention program as part of the study; has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

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

In this single-blind Amylin (Islet Amyloid Polypeptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2006-11 with completion listed for 2007-08.

It ran at 16 sites in United States (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: All treatment-emergent adverse events occurring during the 24-week treatment period (time frame: 24 weeks). Absolute change in body weight from baseline to Week 12 (time frame: 12 weeks).

It also tracked 7 secondary outcomes, for example Percent change in body weight from baseline to Week 12, Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24, Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24, Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24, Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24 and Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 258 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.