A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

Study Overview
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Brief Summary
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This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389

Official Title
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A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: PF 05212389 or placebo
* Drug: PF 05212389 or placebo
* Drug: PF 05212389 or placebo
* Drug: PF 05212389 or placebo
* Drug: PF 05212389 or placebo
* Drug: PF 05212389 or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: PF 05212389 or placebo<br>* QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.<br>|
| Experimental: Cohort 2<br> | Drug: PF 05212389 or placebo<br>* QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.<br>|
| Experimental: Cohort 3<br> | Drug: PF 05212389 or placebo<br>* QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts<br>|
| Experimental: Cohort 4<br> | Drug: PF 05212389 or placebo<br>* QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts<br>|
| Experimental: Cohort 5<br> | Drug: PF 05212389 or placebo<br>* QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts<br>|
| Active Comparator: Cohort 6<br> | Drug: PF 05212389 or placebo<br>* QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Incidence, severity and duration of nausea and vomiting collected as adverse events. |  | Day 1 to day 28 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| - 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 |