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Efficacy and Safety of ATL-962 in Obese Diabetics

This study has been completed.
Sponsor:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00156897
First received: September 8, 2005
Last updated: August 25, 2006
Last verified: August 2006
History of Changes

September 8, 2005
August 25, 2006
December 2004
Not Provided
Absolute weight loss compared to baseline
Same as current
Complete list of historical versions of study NCT00156897 on ClinicalTrials.gov Archive Site
  • 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
  • Changes in other safety parameters
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Non-Insulin-Dependent Diabetes Mellitus
  • Obesity
  • Drug: ATL-962
  • Drug: Orlistat
Not Provided
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. Epub 2009 May 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
October 2005
Not Provided

Inclusion Criteria:

  • Type II diabetes
  • Body mass index 28-45kg/m2
  • HbA1c 6%-10%

Exclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Netherlands,   Sweden,   United Kingdom
 
NCT00156897
ATL-962/175/CL
Not Provided
Not Provided
Alizyme
Not Provided
Principal Investigator: Peter Kopelman Queen Mary's School of Medicine & Dentistry, London, UK
Alizyme
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP