Phase II, multicentre, double blind, placebo controlled, parallel group, dose ranging study of ATL-962 (cetilistat) to assess weight loss, safety and tolerability in obese patients with Type II diabetes being treated with metformin, in comparison with orlistat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Peter Kopelman
Scientific

Barts and The London
Queen Mary's School of Medicine & Dentistry
30-32 Newark Street
London
E1 2AA
United Kingdom

Primary study design	Interventional
Study design	Randomised three arm placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does ATL-962 induce weight loss in diabetic patients and is its safety and tolerability profile superior to that of orlistat in such patients?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Obesity in patients with Type II diabetes
Intervention	ATL-962 (40 mg, 80 mg, or 120 mg), or placebo, or orlistat (120 mg) three times a day for 12 weeks
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	ATL-962 (cetilistat), orlistat, metformin
Primary outcome measure(s)	Absolute weight loss compared to baseline
Key secondary outcome measure(s)	Proportion of patients achieving 5% or 10% weight loss; changes in waist circumference; changes in lipid profiles; changes in markers of diabetes; incidence of GI adverse events; changes in other safety parameters
Completion date	30/06/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Not Specified
Target sample size at registration	600
Key inclusion criteria	1. Type II diabetic patients 2. Aged 18-65 3. Body Mass Index (BMI) between 28 kg/m2 and 45 kg/m2 4. Glycosylated haemaglobin (HbA1c) value between 6% and 10% 5. Being treated with a stable dose of metformin
Key exclusion criteria	1. Significant weight loss in the previous 3 months 2. Weight gain during the run-in period 3. Other serious systemic disease, except for controlled hypertension, mild asthma, and primary hypothyroidism 4. History of GI disorders 5. Previous surgery for weight loss
Date of first enrolment	01/12/2004
Date of final enrolment	30/06/2005

Barts and The London

London
E1 2AA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No