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

Phase 2TerminatedNCT00746824

7TM Pharma A/S192 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

192

Conditions

Obesity

Interventions

TM30339 and/or placeboDRUG

The drug and/or placebo will be injected in the abdominal area (site to vary for each injection). Injections will be administered twice daily for 28 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.