Efficacy and Safety of ATL-962 in Obese Diabetics

Alizyme

Status and phase

Completed

Phase 2

Conditions

Obesity

Non-Insulin-Dependent Diabetes Mellitus

Treatments

Drug: ATL-962

Drug: Orlistat

Study type

Interventional

Funder types

Industry

Identifiers

NCT00156897

ATL-962/175/CL

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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