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MK 0773

Phase 1

Osteoporosis | Small molecule | Endocrine |Merck & Company, Inc.|Last Updated: Aug 10, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

MK 0773 · 1 trial · 1 indication

Phase 1 1

NCT01011725Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)Osteoporosis

COMPLETED67 Analytics

PHASE1COMPLETED

Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)

Osteoporosis

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Study Endpoints

Primary Endpoints

Number of Participants with Serious Clinical Adverse Events

From date of enrollment through 12 weeks of study

Number of Participants with Nonerserious Clinical Adverse Events

From date of enrollment through 12 weeks of study

Number of Participants with Serious Laboratory Adverse Events

From date of enrollment through 12 weeks of study

Number of Participants with Nonserious Laboratory Adverse Events

From date of enrollment through 12 weeks of study

Number of Participants Who Discontinued Due to Any Adverse Event

From date of enrollment through 12 weeks of study

Number of Participants Who Withdrew Consent and Discontinued the Study

From date of enrollment through 12 weeks of study

Least Squares Mean Change in Lean Body Mass

From baseline, at 12 weeks

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Postmenopausal Women- Active Agent Group	EXPERIMENTAL	-
Postmenopausal Women- Placebo	PLACEBO_COMPARATOR	Placebo

Interventions

Name	Type	Description
MK 0773	DRUG	25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
Placebo	DRUG	Placebo oral tablet b.i.d for 12 weeks

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Eligibility Criteria

Age Range18 Years to 65 Years

SexFEMALE

Healthy VolunteersYes

Inclusion Criteria: * Subject is a nonsurgical postmenopausal female * Subject is neither grossly overweight nor underweight for her height * Subject is in good health * Subject is willing to avoid excess alcohol and strenuous physical activity during the study * Subject agrees to refrain from cons...

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Competitive Landscape -Osteoporosis 8 trials

Company	Ticker	Trials	Lead Phase	Drugs
Zimmer Biomet Holdings, Inc.	ZBH	1	-	Undisclosed
Precision BioSciences, Inc.	DTIL	1	N/A	Undisclosed
SI-BONE, Inc.	SIBN	1	-	Undisclosed

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Frequently asked questions about MK 0773

What is MK-0773 used for?

MK-0773 is an investigational small molecule being studied for sarcopenia, or loss of muscle mass, in women aged 65 years and older. It has also been evaluated in healthy postmenopausal women and healthy older men. The drug is being developed by Merck & Company, Inc. (MRK).

Who makes MK-0773?

MK-0773 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company has conducted clinical trials of the drug in sarcopenia, osteoporosis, and healthy volunteers.

What phase is MK-0773 in?

MK-0773 has completed a Phase 2 clinical trial in women with sarcopenia. It has also completed two Phase 1 trials, one in healthy postmenopausal women and one in healthy older men. The drug is investigational and not approved.

What clinical trials is MK-0773 in?

MK-0773 has been studied in three completed trials. NCT00529659 was a Phase 2 study in women with sarcopenia. NCT01011725 was a Phase 1 study in healthy postmenopausal women with osteoporosis. NCT01017458 was a Phase 1 study in healthy older men.

Is MK-0773 the same as MK0773?

Yes, MK-0773 and MK0773 refer to the same drug. Clinical trial records use both spellings, with NCT00529659, NCT01011725, and NCT01017458 all studying this compound.