Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
600 participants
INTERVENTIONAL
2004-12-31
2005-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ATL-962
Orlistat
Eligibility Criteria
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Inclusion Criteria
* Body mass index 28-45kg/m2
* HbA1c 6%-10%
Exclusion Criteria
* Weight gain during the run-in period
* Other serious systemic conditions, except controlled hypertension, mild asthma, and primary hypothyroidism
* History of GI disorders
* Previous surgery for weight loss
18 Years
65 Years
ALL
No
Sponsors
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Alizyme
INDUSTRY
Principal Investigators
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Peter Kopelman
Role: PRINCIPAL_INVESTIGATOR
Queen Mary's School of Medicine & Dentistry, London, UK
Locations
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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
Oulun Diakonissalaitos
Oulu, , Finland
University of Oulu
Oulu, , Finland
Turku University Hospital
Turku, , Finland
Allevon
Den Bosch Ziekenhuis, , Netherlands
Allevon
DN de Bilt, , Netherlands
Zeikenhuisgroep Twente
Hengelo, , Netherlands
Nederlandse Obesitas Klinik
Hilversum, , Netherlands
Sint Franciscus Gasthuis
Rotterdam, , Netherlands
Sahlgrenska University Hospital
Gothenburg, , Sweden
Linkoping University Hospital
Linköping, , Sweden
Karolinsaka University Hospital
Stockholm, , Sweden
Norrlands Universitetssjukhus
Umeå, , Sweden
Samariterhemmets Sjukhus
Uppsala, , Sweden
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Clinical Research Centre Edgbaston
Birmingham, , United Kingdom
Walsgrave Hospital
Coventry, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Clinical Research Centre, Crosby
Liverpool, , United Kingdom
Liverpool University Hospital
Liverpool, , United Kingdom
Queen Mary's School of Medicine & Dentistry
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Luton & Dunstable Hospital
Luton, , United Kingdom
Clinical Research Centre
Manchester, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Clinical Research Centre
Wigan, , United Kingdom
Countries
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References
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Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI. Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical). Obesity (Silver Spring). 2010 Jan;18(1):108-15. doi: 10.1038/oby.2009.155. Epub 2009 May 21.
Other Identifiers
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ATL-962/175/CL
Identifier Type: -
Identifier Source: org_study_id