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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014