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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00148382
Enrollment
80
Registered
2005-09-08
Start date
2005-04-30
Completion date
2005-07-31
Last updated
2007-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Pharmacokinetics, Pharmacodynamics

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

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.

Interventions

Sponsors

Alizyme
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics of metabolites of ATL-962

Secondary

MeasureTime frame
Effect of ATL-962 on faecal fat excretion
Safety and tolerability of ATL-962

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026