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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:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00148382
First received: September 7, 2005
Last updated: April 10, 2007
Last verified: April 2007
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148382

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

No publications provided

ClinicalTrials.gov Identifier: NCT00148382     History of Changes
Other Study ID Numbers: ATL-962/191/CL
Study First Received: September 7, 2005
Last Updated: April 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Alizyme:
Obesity
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013