Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants

What Was Tested

This registered phase 2 trial tested Setmelanotide.

The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion.

It had two arms (groups): Setmelanotide (experimental) and Placebo (placebo comparator).

Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 74 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 age of 18 and 65. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures. Stable body weight (+/- 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 42 exclusion criteria; among the exclusions: thyroid stimulating hormone (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.

The participants were allocated by chance, so the Setmelanotide group and the comparison group should start out alike.

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 2013-01-14 with completion listed for 2013-09-28.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Body Weight (time frame: Baseline and Day 90).

It also tracked 11 secondary outcomes, for example Change From Baseline in Body Weight, Number of Participants Who Consistently Achieved Targeted Plasma Concentration of ~6 Nanogram Per Milliliter (ng/mL), Percentage of Participants With Treatment Emergent Adverse Events, Change From Baseline in Ambulatory Blood Pressure Monitoring Parameter (ABPM) - Systolic Blood Pressure, Change From Baseline in ABPM - Diastolic Blood Pressure and Change From Baseline in ABPM - Mean Arterial Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Setmelanotide in 74 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.