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orlistat

Phase 1

Overweight | Small molecule | Metabolic |GSK plc|Last Updated: Jan 28, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

orlistat · 1 trial · 1 indication

Phase 1 1
NCT01550926A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage FormsOverweight
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
OverweightUnlock trial analytics

Study Endpoints

Primary Endpoints

Fecal fat excretion
9 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR60 mg orlistat
Arm 2ACTIVE_COMPARATOR120 mg orlistat (2 X 60 mg capsules)
Arm 3EXPERIMENTALorlistat experimental formulation

Interventions

NameTypeDescription
120 mg orlistatDRUG2 X60 mg capsule
60 mg orlistatDRUG60 mg orlistat
orlistat experimental doseDRUGexperimental
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:United Kingdom
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Frequently asked questions about orlistat

What is orlistat used for?

Orlistat is a small molecule drug being studied for use in overweight individuals. It is in Phase 1 clinical development and is being developed by GSK plc. The drug is intended to address conditions related to being overweight, though it remains investigational and has not been approved for this use.

Who makes orlistat?

Orlistat is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's pharmacological equivalence in overweight individuals, with the drug currently in Phase 1 development.

What phase is orlistat in?

Orlistat is in Phase 1 clinical development. It is an investigational drug being studied for overweight individuals, and it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, with 48 participants enrolled in the study.

What clinical trials is orlistat in?

Orlistat has one completed clinical trial, identified as NCT01550926, which assessed the pharmacologic equivalence of two orlistat dosage forms. The trial was a Phase 1, randomized, active-controlled study conducted in the United Kingdom with 48 participants who were overweight. The study has been completed.

Is orlistat the same as any other drug?

Orlistat is the drug name used in clinical development by GSK plc. No alternative names have been reported for this drug in the context of its current Phase 1 trial. The drug is being studied specifically for its effects in overweight individuals.