Subcutaneous oxyntomodulin reduces body-weight in overweight subjects

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof S R Bloom
Scientific

Hammersmith Hospital
Commonwealth Building
Department of Metabolic Medicine
Du Cane Road
London
W12 0NN
United Kingdom

Phone	+44 (0)20 8383 3242
Email	s.bloom@imperial.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Subcutaneous oxyntomodulin reduces body-weight in overweight subjects
Study objectives	The effect of self-administered subcutaneous oxyntomodulin on overweight volunteers was investigated in a four-week community-based study. We hypothesised oxyntomodulin would reduce body weight and appetite.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Obesity
Intervention	Healthy overweight volunteers self-administered either saline or oxyntomodulin subcutaneously for four weeks, three times daily, 30 minutes before each meal, in a randomised double-blind parallel-group protocol. The volunteers were asked to maintain their regular diet and level of physical exercise. Subjects' body weight, energy intake and levels of adipose hormones were assessed at the start and end of the study.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Oxyntomodulin
Primary outcome measure(s)	Body weight, energy intake and adipose hormones.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/08/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	26
Key inclusion criteria	1. Healthy male and female volunteers, aged 18 to 55 years 2. A stable Body Mass Index (BMI) between 25 and 40 kg/m^2
Key exclusion criteria	1. Abnormal eating behaviour 2. A current medical condition 3. Abnormal ElectroCardioGram (ECG) 4. Abnormal blood tests 5. Pregnancy or breastfeeding 6. Blood donation or participation in another research study within the last three months
Date of first enrolment	02/01/2004
Date of final enrolment	01/07/2004

Hammersmith Hospital

London
W12 0NN
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	01/08/2005		Yes	No