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OpenTrials
Completed

NCT Number: NCT00148382

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SFBCI

Miami, Florida, 33181, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATL-962

Drug

Primary outcomes

  1. Pharmacokinetics of metabolites of ATL-962

Secondary outcomes

  1. Effect of ATL-962 on faecal fat excretion

  2. Safety and tolerability of ATL-962

Sponsors and collaborators

Lead sponsor

Alizyme

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Apr 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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