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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATL-962 | Drug | |||
| Orlistat | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute weight loss compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving 5% or 10% weight loss | ||
| Changes in waist circumference | ||
| Changes in lipid profiles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kopelman | Queen Mary's School of Medicine & Dentistry, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Sygehus Nord | Aalborg | Denmark | ||||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19461584 | Derived | 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. |
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| Changes in markers of diabetes |
| Incidence of gastrointestinal adverse effects |
| Changes in other safety parameters |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C520092 | cetilistat |
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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