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RO5093151

Phase 2

Hypertension, Glaucoma, Open-Angle | Small molecule | Cardiovascular |Roche Holding AG|Trials Updated: Mar 14, 2018

RO5093151 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Jan 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment158

FDA Designations

No designations recorded

RO5093151 clinical trials

RO5093151 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT01493271A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle GlaucomaHypertension, Glaucoma, Open-Angle
COMPLETED31 Analytics
PHASE2COMPLETED
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
Hypertension, Glaucoma, Open-AngleUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Day 7
Incidence of adverse events
Up to 12 weeks
Changes in vital signs, electrocardiogram (ECG), opthalmologic assessments, and clinical laboratory results
Up to 12 weeks
Change in mean IOP after 7 days treatment vs baseline: change from baseline for RO5093151 and latanoprost and difference in change from baseline between RO5093151 and latanoprost
Baseline (Day 1) and Day 8
Change of liver fat content measured by magnetic resonance spectroscopy (MRS)
Week 12

Secondary Endpoints

Change in mean daily intraocular pressure (IOP)
Up to 28 days
Change in mean intraocular pressure (IOP) at each assessment time-points
Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase
7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO5093151EXPERIMENTAL -
Part AEXPERIMENTALParticipants will receive up to 3 multiple ascending dose levels with the starting dose of 0.1% RO5093151 (topical ocular instillation) and sequentially 0.5% and 1% RO5093151 doses or placebo (3:1, active:placebo) twice a day (BID) on Day 1 and once a day (QD) for 6 days.
Part BEXPERIMENTALParticipants will receive highest feasible dose (HFD) or maximum tolerated dose (MTD) of RO5093151 from Part A or 0.005% latanoprost (topical ocular instillation) once daily for 7 days.
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGPlacebo to RO5093151
RO5093151DRUGoral doses twice daily for up to 28 days
LatanoprostDRUGLatanoprost is a ophthalmic solution, available in dose strength as 0.005%.
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Adult patients, at least 21 years of age, inclusive * Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye * Able to participate and willing to give informed consent Exclusion Criteria: * Presence of extreme narrow angle with complete or partia...

Countries:United StatesBulgariaCzechiaHungarySingaporeAustriaGermany
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Frequently asked questions about RO5093151

What is RO5093151?

RO5093151 is an investigational small molecule developed by Roche Holding AG. It has been studied in clinical trials for non-alcoholic fatty liver disease (NAFLD) and for ocular hypertension or open-angle glaucoma. It is not described as an approved medicine and remains in clinical development.

What is RO5093151 used for?

RO5093151 has been studied in trials for non-alcoholic fatty liver disease, including fatty liver, and for ocular hypertension and open-angle glaucoma. These studies evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is investigational and has not been described as approved for any indication.

Who makes RO5093151?

RO5093151 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical studies of the compound in patients with non-alcoholic fatty liver disease and in patients with ocular hypertension or open-angle glaucoma.

What phase is RO5093151 in?

RO5093151 is in Phase 1 development. One completed Phase 1 study enrolled 82 patients with non-alcoholic fatty liver disease, and a completed Phase 2 study enrolled 31 patients with ocular hypertension or open-angle glaucoma. The compound is investigational and is not described as FDA approved.

What clinical trials is RO5093151 in?

RO5093151 has been evaluated in completed trials including NCT01277094, a Phase 1 study in non-alcoholic fatty liver disease with 82 patients, NCT02622334, a Phase 1 study in primary open-angle glaucoma or ocular hypertension with 45 patients, and NCT01493271, a Phase 2 study in ocular hypertension or open-angle glaucoma with 31 patients.

What does RO5093151 target?

RO5093151 is a small molecule, but its specific molecular target is not identified in the available trial information. Its clinical studies assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with non-alcoholic fatty liver disease and in patients with ocular hypertension or open-angle glaucoma.