Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148382
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 11, 2007
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Brief Summary:
The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces in subjects who are obese

Condition or disease Intervention/treatment Phase
Obesity Drug: ATL-962 Phase 1

Detailed Description:
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Parallel Group, Repeat Dose Pharmacokinetic and Pharmacodynamic Study of Four Doses of ATL-962 (40mg, 80mg, 120mg 240mg) in Otherwise-Healthy Obese Volunteers
Study Start Date : April 2005
Study Completion Date : July 2005

Primary Outcome Measures :
  1. Pharmacokinetics of metabolites of ATL-962

Secondary Outcome Measures :
  1. Effect of ATL-962 on faecal fat excretion
  2. Safety and tolerability of ATL-962

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Obese, otherwise-healthy subjects
  • Body mass index 30-45kg/m2

Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Any drug treatment within 2 weeks of commencement of dosing in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148382

United States, Florida
Miami, Florida, United States, 33181
Sponsors and Collaborators
Principal Investigator: Lawrence Galitz SFBCI Identifier: NCT00148382     History of Changes
Other Study ID Numbers: ATL-962/191/CL
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007

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