A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01472848

Enrollment

Registered

2011-11-17

Start date

2011-04-30

Completion date

2011-08-31

Last updated

2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

Interventions

DRUGPF 05212389 or placebo

QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026