A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

What Was Tested

The trial (phase 3) is built around Relamorelin.

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

The registry classes the interventions as drug.

Who Took Part

450 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: They had vomiting episodes and an average daily DGSSS of ≥12 but \<16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device. Compliance with the entry of data into the hand-held electronic device during the Run-in Period. Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period. The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12.

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: rollover participants; history of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of the screening visit; history of intestinal malabsorption or pancreatic exocrine insufficiency.

How the Study Was Run

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

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

The Relamorelin group and the comparison group ran side by side rather than switching.

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 and investigator.

It started in 2018-02-01 with completion listed for 2020-11-05.

It ran at 349 sites in United States (183), India (22), Ukraine (16), Mexico (13), Colombia (11) and United Kingdom (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS). Change From Baseline to Week 52 in the Weekly Average DGSSS. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Relamorelin in 450 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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