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MK0557

Phase 3

Obesity | Small molecule | Metabolic |Merck & Company, Inc.|Trials Updated: Jan 2, 2017

MK0557 development status

Highest phase Phase 3
Registered trials 5 across 1 sponsor since Sep 2004

MK0557 target and mechanism

Molecular targetNPY5R
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment2,406

FDA Designations

No designations recorded

MK0557 clinical trials

MK0557 · 5 trials · 3 indications

Phase 3 2Phase 2 3
NCT00092872A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)Obesity
COMPLETED359 Analytics
NCT00092859A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)Obesity
COMPLETED1,500 Analytics
PHASE3COMPLETED
A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
ObesityUnlock trial analytics
PHASE3COMPLETED
A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Body weight after 1 year of treatment.
After 1 year of treatment
Safety and tolerability.
After 1 year of treatment
Body weight after 1 year of treatment. Safety and tolerability for 2 years.
After 1 & 2 years of treatment
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
at 4 weeks of treatment

Secondary Endpoints

Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years
After 2 years
Durability of weight loss over two years.
Over two years.
Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory
at 4 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1OTHERMK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd.
2OTHERMK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd.

Interventions

NameTypeDescription
MK0557DRUG -
Comparator: Placebo (unspecified)DRUGMK0557 Pbo tablet qd for a 15-wk treatment period
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study. Exclusion Criteria: * Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

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Frequently asked questions about MK0557

What is MK0557 used for?

MK0557 was studied for the treatment of obesity and for paranoid schizophrenia, specifically cognitive impairment in patients with schizophrenia. It is an investigational small molecule that was developed by Merck & Company, Inc. and tested in four completed clinical trials across these two indications.

What does MK0557 target?

MK0557 targets NPY5R, the neuropeptide Y Y5 receptor, and acts as an antagonist. By blocking this receptor, the drug was designed to interfere with neuropeptide Y signaling, a pathway implicated in appetite regulation and body weight control, which is why obesity was a primary focus of its clinical development.

Who makes MK0557?

MK0557 was developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the clinical trial program for the compound, including studies in obesity and in cognitive impairment associated with schizophrenia.

What phase is MK0557 in?

MK0557 reached Phase 3 in obesity, with a one-year study in obese patients. All four clinical trials of MK0557 are listed as completed, and no trials are currently active. The compound remains an investigational drug and is not approved for any indication.

What clinical trials is MK0557 in?

MK0557 has been evaluated in four completed trials: NCT00533598 and NCT00533481 in obesity, NCT00482430 in cognitive impairment in schizophrenia, and NCT00092872, a Phase 3 one-year obesity study. Total enrollment across these trials was approximately 2,356 participants.