Efficacy and Safety of ATL-962 in Obese Diabetics

A

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

37

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Data sourced from clinicaltrials.gov

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