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This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Cohort 5 | Experimental |
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| Cohort 6 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF 05212389 or placebo | Drug | QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| - Incidence, severity and duration of nausea and vomiting collected as adverse events. | Day 1 to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| - Change in body weight from baseline | Day 1 to day 28 | |
| - Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline | Day 1 to day 28 | |
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Inclusion Criteria:
Obesity
Exclusion Criteria:
Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| PF 05212389 or placebo | Drug | QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose. |
|
| PF 05212389 or placebo | Drug | QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts |
|
| PF 05212389 or placebo | Drug | QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts |
|
| PF 05212389 or placebo | Drug | QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts |
|
| PF 05212389 or placebo | Drug | QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts |
|
| - Multiple dose PK parameters of PF 05212389 |
| Day 1 to day 28 |
| - Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason | Day 1 to day 28 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |