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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148382
First Posted: September 8, 2005
Last Update Posted: April 11, 2007
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.
Information provided by:
Alizyme
  Purpose
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 Intervention Phase
Obesity Drug: ATL-962 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Alizyme:

Primary Outcome Measures:
  • Pharmacokinetics of metabolites of ATL-962

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

Estimated Enrollment: 80
Study Start Date: April 2005
Estimated Study Completion Date: July 2005
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00148382


Locations
United States, Florida
SFBCI
Miami, Florida, United States, 33181
Sponsors and Collaborators
Alizyme
Investigators
Principal Investigator: Lawrence Galitz SFBCI
  More Information

ClinicalTrials.gov Identifier: NCT00148382     History of Changes
Other Study ID Numbers: ATL-962/191/CL
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: April 11, 2007
Last Verified: April 2007

Keywords provided by Alizyme:
Obesity
Pharmacokinetics
Pharmacodynamics