Phase
Condition
Obesity
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Body mass index (BMI)> 25 kg/m²
Exclusion
Exclusion Criteria:
Absence of stable weight (variation < 5 kg) within three months prior to screeningvisit),
Absence of effective contraceptive method for females of childbearing potential,
Presence of treated or untreated type 1 or type 2 diabetes,
Systolic blood pressure > 165 mm Hg and/or diastolic blood pressure > 105 mm Hg on 2consecutive visits from the screening to the inclusion visit,
Presence of secondary hypertension,
Patients with conditions/concomitant diseases making them non evaluable for theprimary efficacy endpoint (presence of any clinically significant endocrine diseaseaccording to the Investigator, obesity of known endocrine origin...)
Presence of any severe medical or psychological condition or chronicconditions/infections that in the opinion of the Investigator would compromise thepatient's safety or successful participation in the study,
Presence of any clinically significant abnormality according to the Investigator onthe ECG performed on the inclusion visit.
Presence or history of cancer within the past five years with the exception ofadequately treated localized basal cell skin cancer or in situ uterine cervicalcancer.
Related to previous or concomitant medications :
Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
Antidiabetic drugs.
Related to laboratory findings:
Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
Abnormal TSH level (TSH > ULN or < LLN).
Positive urine pregnancy test.
Study Design
Connect with a study center
Sanofi-Aventis
Shangai, 200040
ChinaSite Not Available
Sanofi-Aventis
Seoul, 135-755
Korea, Republic ofSite Not Available
Sanofi-Aventis
Taipei, 105
TaiwanSite Not Available

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