Recent Updates
Recently added Catalysts

MK0557

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment2,356

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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)

Unlock Eligibility Criteria

Frequently asked questions about MK0557

What is MK0557 used for?

MK0557 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for the treatment of obesity and paranoid schizophrenia. It is in Phase 3 clinical development for obesity, with completed trials in this indication. The drug is not approved and remains under clinical investigation.

Who makes MK0557?

MK0557 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials of this investigational small molecule for obesity and paranoid schizophrenia. Merck is responsible for the drug's development and clinical testing.

What phase is MK0557 in?

MK0557 is in Phase 3 clinical development for obesity. It has completed four clinical trials, including two Phase 3 studies and two Phase 2 studies, all in obese patients. The drug remains investigational and is not yet approved for any use.

What clinical trials is MK0557 in?

MK0557 has completed four clinical trials. These include NCT00092859, a 2-year Phase 3 study in 1500 obese patients; NCT00092872, a 1-year Phase 3 study in 359 obese patients; NCT00533481, a Phase 2 combination study with sibutramine or orlistat in 497 patients; and NCT00533598, a Phase 2 study in obese subjects.

Is MK0557 the same as other obesity drugs?

MK0557 is a distinct investigational drug developed by Merck. It has been studied alone and in combination with other weight-loss medications like sibutramine and orlistat in clinical trials. No alternative names for MK0557 have been reported in the available trial data.