Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RM-131, Ghrelin receptor agonist
Relamorelin · 6 trials · 9 indications
Change from baseline colonic geometric center at 24 hours
Change from baseline in body weight.
Change from baseline in gastric half-emptying time (t½)
Calculation of gastric volume by single photon emission computed tomography (SPECT)
Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink
Measurement of gastric motility by gastroduodenal manometry
Change from baseline HAPC
Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)
| Arm | Type | Description |
|---|---|---|
| RM-131 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Relamorelin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| RM-131 | DRUG | Double blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days. |
| Placebo | DRUG | Placebo delivered subcutaneously once daily for 14 days. |
| Relamorelin | DRUG | Double blind RM-131 will be delivered three times by injection during the course of the study |
Inclusion criteria * Able to provide written informed consent prior to any study procedures, and willing and able to comply with study procedures. * Diagnosis of chronic IDIOPATHIC constipation, including experiencing constipation for 12 or more weeks in the preceding 12 months (defined by Rome III...
Relamorelin is an investigational small molecule developed by Rhythm Pharmaceuticals, Inc. (ticker RYTM) for gastric motility. It is being studied in the gastrointestinal therapeutic area. Relamorelin has completed a Phase 1 clinical trial and is not yet approved for any indication.
Relamorelin targets GHSR, the growth hormone secretagogue receptor. It acts as an agonist at this receptor. This mechanism is being investigated for its effects on gastric motility.
Relamorelin is being developed by Rhythm Pharmaceuticals, Inc., which trades under the ticker symbol RYTM. The company is responsible for its clinical development program.
Relamorelin is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It remains an investigational drug and has not been approved by the FDA for any indication.
Relamorelin has been studied in one completed Phase 1 trial, NCT02466711, titled "Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers." The trial enrolled 16 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.