Clinical trial NCT00746824: A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
Official title: TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
weight loss
7TM Pharma
TM30339
Y4 receptor antagonist
Lead sponsor: 7TM Pharma A/S
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 increasing both in developed and developing countries. There is a great need for further medicinal treatments that effectively will support life style changes or surgical procedures in reducing or maintaining bodyweight.

7TM Pharma has identified TM30339 as a clinical development candidate molecule with potential to assist in the control and amelioration of obesity in humans.

Eligibility 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

Primary outcomes:
measure: The primary endpoint is the change in body weight from baseline (Visit 1) to Visit 5 (the 29th day),which will be computed for each patient and then averaged for each dose arm.
timeFrame: Visit 5 (the 29th day)
Secondary outcomes:
measure: To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio
timeFrame: Visit 5 (the 29th day)
measure: To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index
timeFrame: Visit 5 (the 29th day)
measure: To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339
timeFrame: Visit 5 (the 29th day)
measure: To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability
timeFrame: Visit 5 (the 29th day)
Other outcomes:
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