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MK0773

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jul 12, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

MK0773 · 1 trial · 1 indication

Phase 1 1
NCT01017458Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)Healthy
COMPLETED68 Analytics
PHASE1COMPLETED
Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects with Clinical Adverse Events (CAE)
12 weeks
Number of subjects with Serious CAEs
12 weeks
Number of subjects with drug-related CAEs
12 weeks
Number of subjects with serious drug-related CAEs
12 weeks
Number of subjects that discontinued with CAEs
12 weeks
Number of subjects with Laboratory Adverse Events (LAE)
12 weeks
Number of subjects with drug-related LAEs
12 weeks
Number of subjects with serious LAEs
12 weeks
Number of subjects with serious drug-related LAEs
12 weeks
Number of subjects that discontinued with LAEs
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMK0773 + placebo injection
2ACTIVE_COMPARATORplacebo to MK0773 + testosterone injection
3PLACEBO_COMPARATORplacebo to MK0773 + placebo injection

Interventions

NameTypeDescription
MK0773DRUGThree 25mg oral tablets MK0773 bid, for 12 weeks
Comparator: testosterone enanthateDRUGintramuscular injection 200mg testosterone enanthate q14d, for 12 weeks
Comparator: placebo oral tabletDRUGplacebo oral tablet bid, for 12 weeks
Comparator: placebo injectionDRUGplacebo intramuscular injection q14d, for 12 weeks
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Eligibility Criteria

Age Range50 Years to 75 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good general health * Subject agrees to avoid excess alcohol and strenuous physical activity during the study * Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study Exclusion...

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Frequently asked questions about MK0773

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.