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RM-131

Phase 2

Anorexia Nervosa | Small molecule | Psychiatry |Rhythm Pharmaceuticals, Inc.|Last Updated: Sep 23, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment20

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
ConstipationUnlock trial analytics
PHASE2COMPLETED
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
Anorexia NervosaUnlock trial analytics
PHASE2COMPLETED
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
Diabetes MellitusUnlock trial analytics

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 studied for multiple conditions, including diabetic gastroparesis in patients with type 1 or type 2 diabetes, anorexia nervosa, and chronic constipation. It has been evaluated in Phase 2 clinical trials for these indications, though it remains investigational and is not approved.

Who makes RM-131?

RM-131 is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker RYTM. The company has sponsored clinical trials of RM-131 in the United States across several gastrointestinal and psychiatric indications.

What phase is RM-131 in?

RM-131 has completed Phase 2 clinical trials for diabetic gastroparesis, anorexia nervosa, and chronic constipation, as well as a Phase 1 study for chronic constipation. It is an investigational drug still in clinical development and has not been approved by regulatory authorities.

What clinical trials is RM-131 in?

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

Is RM-131 the same as any other drug?

RM-131 is the investigational name used by Rhythm Pharmaceuticals for this small molecule compound. No alternative names have been reported in the clinical trial records, so it is not known to be marketed under any other designation.