Status:
TERMINATED
A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
Lead Sponsor:
7TM Pharma A/S
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.
Detailed Description
Obesity is a disease with large socioeconomic consequences and many serious health consequences including Type 2 diabetes, dyslipidemia and cardiovascular diseases. The prevalence of obesity is increa...
Eligibility Criteria
Inclusion
- Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive
- Age 18-60 years inclusive
- Stable lifestyle e.g. smoking, exercise and eating patterns and times for at least 6 months, and willing to maintain these habits during the course of the study
- Stable weight over past 2 months i.e. a change in body weight \< 3 kg as reported by the subject
Exclusion
- Subjects with a history of allergies toward products containing natural rubber (e.g. latex)
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (including bariatric surgery), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, or other major disorders
- Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes
- Subjects who have a QTc (Bazett's correction) interval of \> 450 msec at screening
- Subjects with bradycardia (heart rate \< 50)
- Subjects with heart block
- Clinically significant thyroid dysfunction as evidenced by TSH \> 1.5 X ULN
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00746824
Start Date
August 1 2008
End Date
March 1 2009
Last Update
September 3 2012
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