Efficacy and Safety of ATL-962 in Obese Diabetics

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156897
• Other study ID #: ATL-962/175/CL
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: August 25, 2006
• Start date: December 2004
• Est. completion date: October 2005

Study information

• Verified date: August 2006
• Source: Alizyme
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Non-Insulin-Dependent Diabetes Mellitus
• Obesity

Intervention

Drug:
• ATL-962

• Orlistat

Locations

Country	Name	City	State
Denmark	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
Finland	Lääkärikeskus Minerva	Eura
Finland	Obesity Research Unit	Helsinki
Finland	Suomen Terveystalo	Jyvaskyla
Finland	Oy Foodfiles Limited	Kuopio
Finland	Oulun Diakonissalaitos	Oulu
Finland	University of Oulu	Oulu
Finland	Turku University Hospital	Turku
Netherlands	Allevon	Den Bosch Ziekenhuis
Netherlands	Allevon	DN de Bilt
Netherlands	Zeikenhuisgroep Twente	Hengelo
Netherlands	Nederlandse Obesitas Klinik	Hilversum
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Sweden	Sahlgrenska University Hospital	Goteborg
Sweden	Linkoping University Hospital	Linkoping
Sweden	Karolinsaka University Hospital	Stockholm
Sweden	Norrlands Universitetssjukhus	Umea
Sweden	Samariterhemmets Sjukhus	Uppsala
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Royal United Hospital	Bath
United Kingdom	Clinical Research Centre Edgbaston	Birmingham
United Kingdom	Walsgrave Hospital	Coventry
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Clinical Research Centre, Crosby	Liverpool
United Kingdom	Liverpool University Hospital	Liverpool
United Kingdom	Hammersmith Hospital	London
United Kingdom	Queen Mary's School of Medicine & Dentistry	London
United Kingdom	Luton & Dunstable Hospital	Luton
United Kingdom	Clinical Research Centre	Manchester
United Kingdom	James Cook University Hospital	Middlesborough
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury
United Kingdom	Clinical Research Centre	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Alizyme

Countries where clinical trial is conducted

Denmark,  Finland,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute weight loss compared to baseline
Secondary	Proportion of patients achieving 5% or 10% weight loss
Secondary	Changes in waist circumference
Secondary	Changes in lipid profiles
Secondary	Changes in markers of diabetes
Secondary	Incidence of gastrointestinal adverse effects
Secondary	Changes in other safety parameters