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LX1033

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Lexicon Pharmaceuticals, Inc.|Trials Updated: Mar 23, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment373

FDA Designations

No designations recorded

LX1033 clinical trials

LX1033 · 1 trial · 1 indication

Phase 2 1
NCT01494233A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel SyndromeIrritable Bowel Syndrome
COMPLETED373 Analytics
PHASE2COMPLETED
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in stool consistency
4 weeks

Secondary Endpoints

Change from baseline in plasma 5-HIAA levels
4 weeks
Change from baseline in worst abdominal pain in past 24 hours
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low doseEXPERIMENTAL500 mg LX1033 two times daily
Mid doseEXPERIMENTAL500 mg LX1033 three times daily
High doseEXPERIMENTAL1000 mg LX1033 two times daily
PlaceboPLACEBO_COMPARATORMatching placebo dosing

Interventions

NameTypeDescription
250 mg LX1033 tabletsDRUG250 mg LX1033 tablets administered orally
Placebo tabletDRUGMatching placebo tablet administered orally
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites81

Inclusion Criteria: * Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis * Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale) * Weekly average of wor...

Countries:United States
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Competitive Landscape -Irritable Bowel Syndrome 15 trials

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Frequently asked questions about LX1033

What is LX1033?

LX1033 is an investigational small molecule developed by Lexicon Pharmaceuticals, Inc. for irritable bowel syndrome. It was studied specifically in patients with diarrhea-predominant IBS. LX1033 has completed a Phase 2 clinical trial and is not an approved therapy. It is also referred to as 250 mg LX1033 tablets.

What is LX1033 used for?

LX1033 was being developed for the treatment of irritable bowel syndrome, specifically the diarrhea-predominant subtype. Its clinical program evaluated safety and efficacy in adults with this condition. LX1033 remains investigational and is not approved for any use.

Who makes LX1033?

LX1033 is developed by Lexicon Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker LXRX. Lexicon is the sponsor of the clinical program evaluating LX1033 in irritable bowel syndrome.

What phase is LX1033 in?

LX1033 has completed a Phase 2 clinical trial in irritable bowel syndrome. It is an investigational drug and has not been approved by the FDA. No active trials of LX1033 are currently listed.

What clinical trials is LX1033 in?

LX1033 was evaluated in one completed Phase 2 trial, NCT01494233, titled a multi-center trial to determine the safety and efficacy of LX1033 in subjects with diarrhea-predominant irritable bowel syndrome. The trial enrolled 373 participants across sites in the United States and was randomized, double-blind, and placebo-controlled.