Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
orlistat experimental dose · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | 60 mg orlistat |
| Arm 2 | ACTIVE_COMPARATOR | 120 mg orlistat (2 X 60 mg capsules) |
| Arm 3 | EXPERIMENTAL | orlistat experimental formulation |
| Name | Type | Description |
|---|---|---|
| 120 mg orlistat | DRUG | 2 X60 mg capsule |
| 60 mg orlistat | DRUG | 60 mg orlistat |
| orlistat experimental dose | DRUG | experimental |
Inclusion Criteria: * age: 18-60 years * Body Mass Index: 25-33 Exclusion Criteria: * gastrointestinal disease * organ transplant * HIV, hepatitis B or C * food allergies * alcohol or other substance abuse * smoking
Orlistat experimental dose is an investigational small molecule developed by GSK plc (ticker GSK) for overweight. It is a Phase 1 candidate that has been studied in a single completed clinical trial. It is not an approved product and remains in clinical development.
Orlistat experimental dose is being developed for overweight. The only clinical trial of this asset enrolled 48 participants with overweight as the studied condition. Because it is still in Phase 1 testing, it is investigational and has no approved use.
Orlistat experimental dose targets LIPF and PNLIP. It is an inhibitor of these targets, which are lipases involved in fat digestion. Inhibiting LIPF and PNLIP is the mechanism by which this small molecule is designed to act in overweight.
Orlistat experimental dose is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this Phase 1 small molecule candidate in overweight.
Orlistat experimental dose is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program has one completed Phase 1 trial, and no active trials are ongoing.
Orlistat experimental dose has been studied in one completed Phase 1 trial, NCT01550926, titled A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms. It enrolled 48 healthy adult volunteers in the United Kingdom, was randomized and active controlled, and has completed.