A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

What Was Tested

In this phase 3 trial, researchers set out to test Relamorelin.

At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

It had five arms (groups): Treatment Period: Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 467 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: Participants are eligible to be included in the study only if all the following criteria apply:. Participant met all inclusion/.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: able to provide written informed consent (ic) prior to any study procedures and willing and able to comply with study procedures; participants are excluded from the study if any of the following criteria apply:; participant is not willing or able to abide by the restrictions regarding concomitant medicine use.

How the Study Was Run

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

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

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 Relamorelin.

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

It started in 2018-01-24 with completion listed for 2020-10-30.

It ran at 337 sites in United States (161), Ukraine (22), India (21), Mexico (13), Colombia (11) and Russia (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) of the Treatment Period (time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study). Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period (time frame: Week 6 to Week 12).

It also tracked 15 secondary outcomes, for example Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period, Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period, Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period, Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period, Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period and 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 467 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.