A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 7TM Pharma A/S

Criteria

Inclusion Criteria:

1. Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive

2. Age 18-60 years inclusive

3. 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

4. Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject

Exclusion Criteria:

1. Subjects with a history of allergies toward products containing natural rubber (e.g. latex)

2. 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

3. Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes

4. Subjects who have a QTc (Bazett's correction) interval of > 450 msec at screening

5. Subjects with bradycardia (heart rate < 50)

6. Subjects with heart block

7. Clinically significant thyroid dysfunction as evidenced by TSH > 1.5 X ULN