Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

What Was Tested

The trial (phase 1, phase 2) is built around Setmelanotide.

The study drug (setmelanotide and placebo) will be administered in a blinded fashion.

It had three arms (groups): Setmelanotide Once Daily (active comparator), one (active comparator) and Placebo (placebo comparator).

Once daily in the morning, equivalent placebo in evening.

Placebo in the morning, placebo in the evening.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 99 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: Be between the ages of 18 and 65 years, inclusive. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures. Body Mass Index: 30 to 40 Kg/m2. Stable body weight by participant report (+/- 5 Kg) during previous 6 months. Willing to maintain a healthy diet and exercise regime throughout study as recommended by counseling at study start.

The full record lists 11 inclusion and 43 exclusion criteria; among the exclusions: TSH level outside the normal range; creatinine \> 1.5 times the upper limit of normal; liver function tests \> 2 times the upper limit of normal.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Setmelanotide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Setmelanotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2014-01 with completion listed for 2014-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Body Weight - Stage A (time frame: Baseline). Percent Change From Baseline in Body Weight at Week 12 - Stage A (time frame: Baseline, Week 12). Body Weight - Stage B (time frame: Baseline).

It also tracked 6 secondary outcomes, for example Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A, Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C, Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A, Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C, Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage A and Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage C.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Setmelanotide in 99 people.

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

More context: the Setmelanotide compound page, all human trials.