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Relamorelin

Phase 1

Gastric Motility | Small molecule | Gastrointestinal |Rhythm Pharmaceuticals, Inc.|Last Updated: Sep 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Relamorelin · 1 trial · 1 indication

Phase 1 1
NCT02466711Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy VolunteersGastric Motility
COMPLETED16 Analytics
PHASE1COMPLETED
Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
Gastric MotilityUnlock trial analytics

Study Endpoints

Primary Endpoints

Gastric volume measured by single photon emission computed tomography (SPECT)
Measured during the 1 hour study procedure

Calculation of gastric volume by single photon emission computed tomography (SPECT)

Satiety measured by the Hunger/Satiety questionnaire
Measured during a 1 hour study procedure

Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink

Gastric motility measured by gastroduodenal manometry
Measured during the 4 hour study procedure

Measurement of gastric motility by gastroduodenal manometry

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
RelamorelinACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RelamorelinDRUGDouble blind RM-131 will be delivered three times by injection during the course of the study
PlaceboDRUGDouble blind Placebo will be delivered three times by injection during the course of the study
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures 2. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus 3. Body mass index of 18-35 kg/m² 4. Female subjects must have...

Countries:United States
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Frequently asked questions about Relamorelin

What is Relamorelin used for?

Relamorelin is an investigational small molecule being developed for gastric motility, a gastrointestinal condition. It is intended to affect stomach function, though it is not yet approved and remains in clinical development.

Who makes Relamorelin?

Relamorelin is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RYTM.

What phase is Relamorelin in?

Relamorelin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Its only clinical trial to date has been completed.

What clinical trials is Relamorelin in?

Relamorelin has one completed Phase 1 trial, NCT02466711, which studied its effect on satiation, gastric volume, gastric accommodation, and distal gastric function in healthy volunteers in the United States. The trial enrolled 16 participants and was randomized, double-blind, and placebo-controlled.

Is Relamorelin the same as any other drug?

No alternative names for Relamorelin have been disclosed. It is identified by its single name in clinical development.