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RM-131

Phase 2

Diabetes Mellitus | Small molecule | Metabolic |Rhythm Pharmaceuticals, Inc.|Last Updated: Sep 23, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

RM-131 · 5 trials · 8 indications

Phase 2 3Phase 1 2
NCT01781104Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic ConstipationConstipation
COMPLETED48 Analytics
NCT01642550Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia NervosaAnorexia Nervosa
COMPLETED20 Analytics
NCT01571297Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic GastroparesisDiabetes Mellitus
COMPLETED204 Analytics
PHASE2COMPLETED
Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
Constipation
NCT0178110448
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PHASE2COMPLETED
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Anorexia Nervosa
NCT0164255020
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PHASE2COMPLETED
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Diabetes Mellitus
NCT01571297204
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Study Endpoints

Primary Endpoints

Effect of RM-131 on colonic transit
End of 14 day Baseline and end of 14 day Treatment periods

Change from baseline colonic geometric center at 24 hours

Effect of RM-131 on body weight
Baseline and Day 28

Change from baseline in body weight.

Effect of RM-131 on gastric emptying time
Screening and Day 28

Change from baseline in gastric half-emptying time (t½)

Effect of RM-131 on postprandial high amplitude propagated contractions (HAPC) per hour
Measured during the 2 hour study procedure

Change from baseline HAPC

Pharmacodynamic (PD) effects of RM-131 on gastric emptying
Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2

Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)

Secondary Endpoints

Safety and tolerability of RM-131
Duration of the study, an expected average of 9 weeks
Effect of RM-131 on stool consistency
Daily for the duration of the study, an expected average of 9 weeks
Effect of RM-131 on gastric emptying time
Baseline and Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RM-131ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RM-131DRUGDouble blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days.
PlaceboDRUGPlacebo delivered subcutaneously once daily for 14 days.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

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...

Countries:United States
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Frequently asked questions about RM-131

What is RM-131 used for?

RM-131 is an investigational small molecule being developed by Rhythm Pharmaceuticals for gastrointestinal and metabolic conditions. It has been studied in clinical trials for diabetic gastroparesis, anorexia nervosa, and chronic constipation. The drug is not approved and remains in clinical development.

What does RM-131 target?

RM-131 targets the ghrelin receptor. It is a ghrelin receptor agonist, which means it activates the receptor to stimulate gastric emptying and gastrointestinal motility. This mechanism is relevant to its studied indications, including diabetic gastroparesis and chronic constipation.

Who makes RM-131?

RM-131 is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol RYTM on the NASDAQ. Rhythm Pharmaceuticals is responsible for the clinical development of RM-131.

What phase is RM-131 in?

RM-131 has completed Phase 2 clinical trials. It has been evaluated in Phase 2 studies for diabetic gastroparesis, anorexia nervosa, and chronic constipation, as well as a Phase 1 study for chronic constipation. The drug is investigational and has not received FDA approval.

What clinical trials is RM-131 in?

RM-131 has been studied in several completed clinical trials. These include NCT01571297, a Phase 2 study in diabetic gastroparesis with 204 participants; NCT01642550, a Phase 2 pilot study in anorexia nervosa with 20 participants; NCT01781104, a Phase 2 study in chronic constipation with 48 participants; and NCT02137642, a Phase 1 study in chronic constipation with 18 participants.

Is RM-131 the same as other drugs?

RM-131 is also known as relamorelin. It is a ghrelin receptor agonist being developed by Rhythm Pharmaceuticals. The drug has been studied under the name RM-131 in clinical trials for gastrointestinal conditions such as diabetic gastroparesis and chronic constipation.