Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers

What Was Tested

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

The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.

It had two arms (groups): Relamorelin (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus. Body mass index of 18-35 kg/m².

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: unable or unwilling to provide informed consent or to comply with study procedures; diagnosis of gastrointestinal diseases; structural or metabolic diseases that affect the gi system.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Relamorelin 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.

As a double-blind Relamorelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2015-06 with completion listed for 2015-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Gastric volume measured by single photon emission computed tomography (SPECT) (time frame: Measured during the 1 hour study procedure). Satiety measured by the Hunger/Satiety questionnaire (time frame: Measured during a 1 hour study procedure). Gastric motility measured by gastroduodenal manometry (time frame: Measured during the 4 hour study procedure).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Relamorelin in 16 people.

Its size is small, so on its own it can only give an early look.

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

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