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

Phase 2

Terminated

• Conditions: Obesity
• Interventions: Drug: TM30339 and/or placebo

• Registration Number: NCT00746824
• Lead Sponsor: 7TM Pharma A/S

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	TM30339 and/or placebo	AM dose: 0.85 mg PM dose: 0.85 mg
4	TM30339 and/or placebo	AM dose: placebo PM dose: 2.55 mg
5	TM30339 and/or placebo	AM dose: 2.55 mg PM dose: 2.55 mg
1	TM30339 and/or placebo	AM dose: 0.85 mg PM dose: placebo
3	TM30339 and/or placebo	AM dose: 2.55 mg PM dose: placebo
6	TM30339 and/or placebo	AM dose: placebo PM dose: placebo

Primary Outcome Measures

Name	Time	Method
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.	Visit 5 (the 29th day)

Secondary Outcome Measures

Name	Time	Method
To determine the effects of TM30339 after 28 days dosing of obese individuals on: Waist, hip, and waist/hip ratio	Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on fasting glucose and insulin, and insulin sensitivity index	Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on formation of antibodies towards the drug, TM30339	Visit 5 (the 29th day)
To determine the effects of TM30339 after 28 days dosing of obese individuals on safety and tolerability	Visit 5 (the 29th day)