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MK0773

Phase 2

Sarcopenia | Small molecule | Musculoskeletal |Merck & Company, Inc.|Trials Updated: Aug 10, 2016

MK0773 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment237

FDA Designations

No designations recorded

MK0773 clinical trials

MK0773 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00529659A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)Sarcopenia
COMPLETED170 Analytics
PHASE2COMPLETED
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
SarcopeniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Participant Lean Body Mass
Baseline, Month 6
Change From Baseline in Bilateral Leg Press (BLP) Measurement
Baseline, Month 6

BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.

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

Secondary Endpoints

Change From Baseline in Participant Short Physical Performance Battery (SPPB)
Baseline, Month 6
Change From Baseline in Participant Gait Speed
Baseline, Month 6
Change From Baseline in Stair Climbing Power
Baseline, Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-0773EXPERIMENTALMK-0773
PlaceboPLACEBO_COMPARATORPlacebo
Postmenopausal Women- Active Agent GroupEXPERIMENTAL -
Postmenopausal Women- PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Comparator: MK-0773DRUGMK-0773 50 mg tablets twice daily, 6 month treatment period
Comparator: PlaceboDRUGPlacebo tablets twice daily, 6 month treatment period
MK 0773DRUG25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
PlaceboDRUGPlacebo oral tablet b.i.d for 12 weeks
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Eligibility Criteria

Age Range65 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Patient is a woman who is 65 years of age or older * Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population * Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activ...

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Frequently asked questions about MK0773

What is MK0773?

MK0773 is an investigational small molecule developed by Merck & Company, Inc. for endocrine-related conditions. It has been studied in clinical trials for osteoporosis and sarcopenia, which is the loss of muscle mass. MK0773 is not approved and remains in clinical development.

What is MK0773 used for?

MK0773 has been studied for the treatment of osteoporosis and sarcopenia. Osteoporosis is a condition characterized by weakened bones, while sarcopenia refers to the loss of muscle mass. Both indications were evaluated in clinical trials, but MK0773 is not approved for any use.

Who makes MK0773?

MK0773 is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical trials evaluating MK0773 in osteoporosis and sarcopenia.

What phase is MK0773 in?

MK0773 is in Phase 1 clinical development. One Phase 1 trial has been completed, and a Phase 2 trial in sarcopenia has also been completed. The drug is investigational and has not been approved by the FDA.

What clinical trials is MK0773 in?

MK0773 has been evaluated in two completed clinical trials. NCT01011725 was a Phase 1 study of safety, tolerability, and efficacy in healthy postmenopausal women with osteoporosis. NCT00529659 was a Phase 2 study of safety and efficacy in women with sarcopenia.

Is MK0773 the same as MK 0773?

Yes, MK0773 is the same as MK 0773. The alternative spelling with a space is sometimes used in study titles and references, such as Comparator: MK-0773. Both names refer to the same investigational drug developed by Merck.