Efficacy and Safety of ATL-962 in Obese Diabetics
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
1 other identifier
interventional
600
5 countries
37
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2004
Shorter than P25 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedAugust 29, 2006
August 1, 2006
September 8, 2005
August 25, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute weight loss compared to baseline
Secondary Outcomes (6)
Proportion of patients achieving 5% or 10% weight loss
Changes in waist circumference
Changes in lipid profiles
Changes in markers of diabetes
Incidence of gastrointestinal adverse effects
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Type II diabetes
- Body mass index 28-45kg/m2
- HbA1c 6%-10%
You may not qualify if:
- Significant weight loss in the previous 3 months
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alizymelead
Study Sites (37)
Aalborg Sygehus Nord
Aalborg, Denmark
Aarhus University Hospital
Aarhus, DK-8000, Denmark
Bispebjerg Hospital
Copenhagen, DK-2400, Denmark
Gentofte Hospital
Hellerup, DK-2900, Denmark
Hvidovre Hospital
Hvidovre, DK-2650, Denmark
Odense University Hospital
Odense, Denmark
Lääkärikeskus Minerva
Eura, 27510, Finland
Obesity Research Unit
Helsinki, 00100, Finland
Suomen Terveystalo
Jyväskylä, 40100, Finland
Oy Foodfiles Limited
Kuopio, Finland
Oulun Diakonissalaitos
Oulu, 90100, Finland
University of Oulu
Oulu, Finland
Turku University Hospital
Turku, 20520, 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, E1 2AA, 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
Related Publications (1)
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.
PMID: 19461584DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kopelman
Queen Mary's School of Medicine & Dentistry, London, UK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
December 1, 2004
Study Completion
October 1, 2005
Last Updated
August 29, 2006
Record last verified: 2006-08