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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01597609 | A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects | PHASE1 | COMPLETED | 60 | — | — | May 22, 2008 | Mar 4, 2010 | Jun 20, 2017 | 1 | United Kingdom |
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
estimate the changes during and after three interventions: (i) calorie restricted diet + a marketed anti-obesity drug (sibutramine), (ii) calorie restricted diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise + sibutramine placebo
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | \- 600 Kcal deficit, Sibutramine placebo |
| Cohort B | EXPERIMENTAL | \- 600 Kcal deficit, Sibutramine 10 mg once daily |
| Cohort C | EXPERIMENTAL | \- 600 Kcal deficit, Moderate exercise (The energy expenditure will be equivalent to 30 minutes of brisk walking/5 times week i.e. \~1,000 Kcal/week) /sibutramine placebo |
| Name | Type | Description |
|---|---|---|
| sibutramine | DRUG | 10 mg, taken orally once per day for 12 weeks |
| sibutramine placebo | OTHER | taken orally once per day for 12 weeks |
Inclusion Criteria: * Subject is a healthy male or female adult subject aged 20 to 55 years, inclusive. Subjects will be allowed in the study if they have medical conditions, such as asthma, which will not compromise the validity of the study in the opinion of the Principal Investigator and Medica...