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IW-9179

Phase 2

Diabetic Gastroparesis | Small molecule | Gastrointestinal |Ironwood Pharmaceuticals, Inc.|Last Updated: Dec 5, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

IW-9179 · 1 trial · 1 indication

Phase 2 1
NCT02289846Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)Diabetic Gastroparesis
COMPLETED90 Analytics
PHASE2COMPLETED
Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
Diabetic GastroparesisUnlock trial analytics

Study Endpoints

Primary Endpoints

Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo BIDPLACEBO_COMPARATORPlacebo once in the morning and once in the evening.
IW-9179 QD AM + Placebo QD PMEXPERIMENTALIW-9179 once in the morning and placebo once in the evening.
Placebo QD AM + IW-9179 QD PMEXPERIMENTALPlacebo once in the morning and IW-9179 once in the evening.
IW-9179 BIDEXPERIMENTALIW-9179 once in the morning and once in the evening

Interventions

NameTypeDescription
IW-9179DRUG -
Matching PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit. * Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus. * Patient has a diagnosis of DGP with no history or evidence of mechanical o...

Countries:United States
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Frequently asked questions about IW-9179

What is IW-9179 used for?

IW-9179 is an investigational small molecule being developed for the treatment of diabetic gastroparesis, a gastrointestinal condition characterized by delayed stomach emptying in patients with diabetes. It is currently in clinical development and has not been approved by the FDA.

Who makes IW-9179?

IW-9179 is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with diabetic gastroparesis.

What phase is IW-9179 in?

IW-9179 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval. Further studies would be needed to establish its safety and effectiveness for diabetic gastroparesis.

What clinical trials is IW-9179 in?

IW-9179 has been studied in a completed Phase 2 clinical trial identified as NCT02289846, titled "Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)." This randomized, double-blind, placebo-controlled trial enrolled 90 participants in the United States and included adults aged 18 years and older.

Is IW-9179 the same as any other drug?

IW-9179 is the primary name used for this investigational drug in clinical research. No alternative names have been reported in the context of its development for diabetic gastroparesis. It is a distinct small molecule being evaluated by Ironwood Pharmaceuticals.