Official Title: “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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: ATL-962
• Drug: Orlistat

Primary Measures

• Absolute weight loss compared to baseline

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alizyme

Overall Clinical Trial Officials and Contacts

Peter Kopelman Principal Investigator Queen Mary's School of Medicine & Dentistry, London, UK  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00156897

Study ID Number: ATL-962/175/CL

ClinicalTrials.gov Identifier: NCT00156897

Health Authority: United Kingdom: Department of Health