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Multicentre Double Blind Placebo Controlled Parallel Group Dose Ranging Study of ATL-962 to Assess Weight Loss, Safety and Tolerability in Obese Patients With Type II Diabetes Being Treated With Metformin, in Comparison With Orlistat
The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic patients and whether its safety and tolerability profile is superior to that of orlistat in such patients
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. In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will investigate the amount of weight lost after 12 weeks' treatment and will compare the safety and tolerability profile of ATL-962 and orlistat.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Aalborg Sygehus Nord
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Odense University Hospital
Odense, Denmark
Lääkärikeskus Minerva
Eura, Finland
Obesity Research Unit
Helsinki, Finland
Suomen Terveystalo
Jyväskylä, Finland
Oy Foodfiles Limited
Kuopio, Finland
Start Date
December 1, 2004
Completion Date
October 1, 2005
Last Updated
August 29, 2006
600
Estimated participants
ATL-962
DRUG
Orlistat
DRUG
Lead Sponsor
Alizyme
NCT07472881
NCT01143454
Data Source & Attribution
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