Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Setmelanotide.

The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion by subcutaneous (SC) infusion or injection.

It had 12 arms (groups): Cohort 1: RM-493 SC Infusion 14 Days (active comparator), Cohort 2: RM-493 SC Infusion 28 Days (active comparator), Cohort 3: RM-493 SC Infusion 28 Days (active comparator), Cohort 4: RM-493 SC Infusion 28 Days (active comparator) and Cohort 5: RM-493 SC Injection 14 days (active comparator).

The registry classes the interventions as drug.

Who Took Part

57 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: Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures. Healthy obese male and female volunteers aged 18 to 55 years, inclusive. Heterozygous subjects may be 18 to 65 years inclusive. Body Mass Index of 30-40 kg/m2, inclusive. Heterozygous subjects may have a broader BMI range; to be eligible heterozygous subjects may have a BMI 27 -55 kg/ m2, inclusive. Stable body weight during the previous 6 months, based on Investigator judgment. Blood pressure \<140/90 mmHg at Screening and D-1. Measurement may be repeated within 24 hours, based on Investigator judgment.

The full record lists 10 inclusion and 33 exclusion criteria; among the exclusions: resting heart rate \<45 bpm or \>90 bpm at screening; abnormal thyroid stimulating hormone (tsh) or thyroxine (t4) levels on screening; presence of a skin lesion suspicious for malignancy, unless excised prior to day 1.

How the Study Was Run

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

Because people in this Setmelanotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 Setmelanotide.

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

It started in 2012-01 with completion listed for 2014-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of adverse events (time frame: Day 1 through Day 14 or Day 28 (depending on Cohort)).

It also tracked 3 secondary outcomes, for example Assessment of weight loss based on weight measurements and Assessment of blood pressure using Ambulatory blood pressure monitors.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Setmelanotide in 57 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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