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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00239174




Registration number
NCT00239174
Ethics application status
Date submitted
13/10/2005
Date registered
14/10/2005
Date last updated
10/12/2008

Titles & IDs
Public title
A Multicenter Study to Evaluate the Efficacy and Safety of of Four Doses of SR147778 in Obese Patients
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study Evaluating the Efficacy and Safety of Four Doses of SR147778 in Obese Patients
Secondary ID [1] 0 0
DRI5029
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR147778

Treatment: Drugs: SR147778


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weight loss at 6 months.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Waist circumference,lipid parameters,glycemic parameters,metabolic syndrome,blood pressure,adipokines,CRP,IL-6,IL-2,patient satisfaction,food behavior,daily caloric intake, and dietary compliance at 6 months.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Patients must voluntarily sign the informed consent,

- Patients must be male or female and aged 18 to 65 years,

- Patients must be able to follow verbal and written instructions,

- Female patients of childbearing potential (pre-menopausal women) must have a confirmed
negative urine b-hCG pregnancy test prior to enrollment and Baseline Visit. They must
use an acceptable double method of birth control (e.g., oral or implanted
contraceptive therapy, or IUDs, plus a barrier such as condom, diaphragm or
spermicide) throughout the study, and accept to repeat urine b-hCG pregnancy test at
designated visits,

- Patients must have a BMI >=30 and <= 40 at screening

- Patients must have had a stable weight (variation of less than 5 kg during the 90 days
preceding the Screening Visit)

- Patients must have shown to be compliant to dietary recommendations between the
Screening and the Baseline Visits

- Patients' physical examination, laboratory evaluations, 12-lead ECG must be within
normal limits (with the exception of abnormalities considered as clinically
insignificant in the opinion of the Investigator and the Center Monitor), or within
predefined limits for hemoglobin (>= 11 g/dL), total cholesterolemia (<= 3 g/L, i.e.
7.7 mmol/L), triglyceridemia (<= 7 g/L, i.e. 7.9 mmol/L), fasting glycemia (<= 1.6
g/L, i.e. 8.9 mmol/L), and hemoglobin A1c (<= 8%).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Female patients who are pregnant or lactating,

- Patients who are considered by the Investigator to be unsuitable candidates for
receipt of an investigational drug,

- Myocardial infarction within 12 months,

- Hypertension (SBP > 160 mmHg; DBP > 95 mmHg),

- Secondary hypertension- Confirmed heart rate < 60 beats/minute,

- Type 1 diabetes, or treated with insulin

- History or presence of pancreatitis,

- History or presence of clinically significant cardiac valve disorder or abnormal
cardiac echography.

- History or concurrent DSM-IV bulimia or anorexia nervosa,

- Patients with mental retardation or any clinically significant psychiatric disorder
(including organic mental disorder) other than mild mood or anxiety,

- History (during the past six months) or concurrent DSM-IV substance abuse or
dependence (excluding nicotine and caffeine as far as patient agrees not to modify
her/his consumption throughout the study),

- Severe or multiple drug allergies,

- Any disorder that may interfere with drug absorption, metabolism distribution or
excretion,

- Presence of any clinically significant gastrointestinal, cardiovascular, hepatic,
renal, hematological, endocrine, dermatological or respiratory disease, or any other
medical condition that might interfere with the evaluation of study medication,

- Prolonged QTcB: > 450 msec for men and > 470 msec for women.

- Patients who test positive for any illicit drug included in the urine drug screen
(THC) at the Screening or the Baseline Visit. Patients positive for benzodiazepines
only may be admitted, if prescribed with stable dose regimen.

- Patients who test positive at the Screening Visit for hepatitis B surface antigen,
hepatitis C antibody, or ALT and/or AST > 2 x upper limit of normal,

- Hb < 11g/dL, fasting glycemia > 1.6 g/L i.e. 8.9 mmol/L, HbA1c > 8%, total
cholesterolemia > 3 g/L i.e. 7.7 mmol/L, or TG > 7 g/L i.e. 7.9 mmol/L, creatinemia >
150 mmol/l- Patients who have received anti-obesity drugs or other drug(s) or
preparation(s) including herbal for weight reduction within three months of Screening
Visit,

- Thyroid therapy, except on replacement therapy.

- Patients using nicotine substitutes or taking bupropion,

- Treated with antidepressant or neuroleptics drug(s) for more than one week within
three months of Screening Visit,

- Treated with non selective systemic antihistamines

- Systemic corticosteroids or inhaled corticosteroids

- Treated with potent inhibitors of CYP3A4

- Consuming more than 20 g/day of alcohol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effect of SR147778 on weight loss over a period of
24 weeks when prescribed with a hypocaloric diet in obese patients. The secondary objective
is to assess the safety and tolerability of SR147778 and to assess the effect of SR147778 on
several secondary parameters (such as waist, metabolic parameters) over a period of 24 weeks
when prescribed with a hypocaloric diet in obese patients.
Trial website
https://clinicaltrials.gov/show/NCT00239174
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martine Laville, MD
Address 0 0
Hôpital Edouard Herriot, Endocrinologie-Diabète-Nutrition, 5 Place d'Arsonval, 69437 LYON cedex 03, France
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications