A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

What Was Tested

The trial (phase 2) is built around Amylin (Islet Amyloid Polypeptide).

Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period.

Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks.

It had two arms (groups): Group A (experimental) and Group B (placebo comparator).

Pramlintide+Metreleptin.

Placebo.

The registry classes the interventions as drug.

Who Took Part

213 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: Is obese with a BMI ≥35 to ≤45 kg/m2. Meets certain requirements with respect to concomitant medications. Has not smoked or used nicotine-containing products for at least 12 months prior to study start.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: has not been enrolled in a weight loss program within 2 months prior to study start.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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 2011-01 with completion listed for 2011-09.

It ran at 18 sites in United States (18).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population (time frame: Day 1 up to Month 6 Follow-Up). Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population (time frame: Baseline to Month 6 Follow Up). Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population (time frame: Week 1 to Month 6 Follow-Up).

It also tracked 1 secondary outcome, for example Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 213 people.

It ended early (terminated); 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.