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ObesityPhase 2NCT00239174

A Multicenter Study to Evaluate the Efficacy and Safety of of Four Doses of SR147778 in Obese Patients

A Phase 2 study testing SR147778 in people with Obesity, run by Sanofi at 5 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
SR147778
How many people
394 participants
Where
5 sitesin 5 countries
Study dates
Nov 2004to Nov 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%).

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

5 sites in 5 countries.

5 sites in 5 countries

Argentina1 site

  • Sanofi-Aventis Administrative Office

    Buenos Aires

Other trials in Argentina

Australia1 site

  • sanofi-aventis Australia & New Zealand administrative office

    Macquarie Park

Other trials in Australia

Finland1 site

  • Sanofi-Aventis Administrative Office

    Helsinki

Other trials in Finland

France1 site

  • Sanofi-Aventis Administrative Office

    Paris

Other trials in France

Spain1 site

  • Sanofi-Aventis Administrative Office

    Barcelona

Other trials in Spain

About this study

Official 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

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.

Conditions
Obesity
Being tested
SR147778
Keywords
obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SR147778Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss at 6 months.

Secondary outcomes (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionNov 2005
  4. Study completionNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00239174
Sponsor's protocol ID
DRI5029
Status last verified
Dec 2008
First submitted
13 Oct 2005
Last updated
10 Dec 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SR147778 in people with Obesity, run by Sanofi at 5 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Argentina, Australia, Finland, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss at 6 months.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00239174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2008.

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Clinical Trial NCT00239174 | AzTrials