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LY333334

Phase 1

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: Oct 23, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment251

FDA Designations

No designations recorded

Clinical trial landscape

LY333334 · 1 trial · 1 indication

Phase 1 1
NCT01250145A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal WomenOsteoporosis, Postmenopausal
COMPLETED251 Analytics
PHASE1COMPLETED
A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women
Osteoporosis, PostmenopausalUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A - Cumulative Skin Irritation by Draize Score
Day 1 through Day 22

Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter \[mm\]).

Part B - Skin Irritation and Sensitization by Draize Score
Days 1 - 19 and 34 - 37

Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).

Secondary Endpoints

Part A - Patch Adhesion Score
Day 1 through Day 22
Part B - Patch Adhesion Score
Days 1 - 19 and 34 - 37
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY333334 + placeboEXPERIMENTALPart A: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days Part B: Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks Rest phase: 2 weeks with no patch application Challenge phase: 80 microgram active patch given once for at least 6 hours

Interventions

NameTypeDescription
LY333334DRUGTransdermal patch
PlaceboDRUGTransdermal patch
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Eligibility Criteria

SexFEMALE
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Are overtly healthy postmenopausal females, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests (for example, subjects who have osteoporosis or stable and/or controlled hyperlipidemia, hypertension, and/or hypothyr...

Countries:United StatesGermanyUnited Kingdom
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Frequently asked questions about LY333334

What is LY333334 used for in postmenopausal osteoporosis?

LY333334 is an investigational small molecule being studied for postmenopausal osteoporosis. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its effects in healthy postmenopausal women, with one completed clinical trial assessing skin irritation and sensitization.

What does LY333334 target?

LY333334 is a small molecule being developed for postmenopausal osteoporosis. Its specific molecular target has not been disclosed in available information. The drug is in Phase 1 clinical trials, and its mechanism of action is not publicly detailed.

Who makes LY333334?

LY333334 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is in Phase 1 clinical development for postmenopausal osteoporosis, with one completed trial involving 251 participants.

What phase is LY333334 in?

LY333334 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, which evaluated the drug's skin irritation and sensitization profile in healthy postmenopausal women.

What clinical trials is LY333334 in?

LY333334 has one completed clinical trial, NCT01250145, titled "A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women." The trial enrolled 251 healthy postmenopausal women in the United States, Germany, and the United Kingdom.

Is LY333334 the same as teriparatide?

LY333334 is being studied as teriparatide in clinical trials. The completed trial NCT01250145 evaluated teriparatide administered transdermally in healthy postmenopausal women. The drug is in Phase 1 development for postmenopausal osteoporosis, and no alternative names have been disclosed beyond this context.