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Adjusted LOA
ML Risk
sibutramine · 1 trial · 1 indication
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...
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Sibutramine is used for obesity. It is being studied as a small molecule treatment for weight loss and regain in healthy obese subjects. The drug is currently in Phase 1 clinical development and is being developed by GSK plc.
Sibutramine targets the reuptake of neurotransmitters, specifically serotonin and norepinephrine, in the brain. By inhibiting their reuptake, it increases their levels in the synaptic cleft, which can help reduce appetite and promote weight loss in obese individuals.
Sibutramine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials for the treatment of obesity.
Sibutramine is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its effects on weight loss and regain in obese subjects.
Sibutramine has one completed clinical trial, NCT01597609, which was a Phase 1 study in the United Kingdom. The trial enrolled 60 healthy obese subjects and was designed to characterize the physiology of weight loss and regain under dietary, behavioral, and pharmacological interventions.
Sibutramine is the same as Meridia, a brand name previously used for the drug. However, the current development program by GSK plc uses the generic name sibutramine. The drug is being studied for obesity in a Phase 1 clinical trial.