Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01041677 | A Study of the Safety of R256918 in Obese Patients | PHASE2 | COMPLETED | 71 | — | — | Feb 1, 2008 | Oct 1, 2008 | Jan 24, 2013 | 3 | Finland, Netherlands +1 |
| NCT00622765 | A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients | PHASE2 | COMPLETED | 321 | — | — | Nov 1, 2007 | Jun 1, 2008 | May 13, 2014 | 18 | Belgium, Denmark +5 |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | R256918 10 mg capsule twice daily |
| 002 | EXPERIMENTAL | R256918 15 mg capsule twice daily |
| 003 | PLACEBO_COMPARATOR | placebo placebo capsule twice daily |
| 004 | PLACEBO_COMPARATOR | placebo Placebo capsule twice daily |
| Name | Type | Description |
|---|---|---|
| R256918 | DRUG | 10 mg capsule twice daily |
| placebo | DRUG | placebo capsule twice daily |
Inclusion Criteria: * Liver fat content (HTGC) between 3% and 15% * Obese defined as BMI between 30 and 50 kg/square meter * Fasting plasma glucose \< 7.0 mmol/liter Exclusion Criteria: * History of Obesity with a known cause (eg. Cushings disease) * Diabetes Mellitus * Weight reducing diet or re...