Efficacy and Safety of ATL-962 in Obese Diabetics

Phase 2

Completed

• Conditions: Non-Insulin-Dependent Diabetes Mellitus; Obesity

• Registration Number: NCT00156897
• Lead Sponsor: Alizyme

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2005-10
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-25
• Last Update Posted: 2006-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absolute weight loss compared to baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (35)

Aalborg Sygehus Nord; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Lääkärikeskus Minerva; 🇫🇮 Eura, Finland

Obesity Research Unit; 🇫🇮 Helsinki, Finland

Suomen Terveystalo; 🇫🇮 Jyvaskyla, Finland

Oy Foodfiles Limited; 🇫🇮 Kuopio, Finland

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