Obesity
Conditions
Keywords
Obesity, weight loss, 7TM Pharma, TM30339, Y4 receptor antagonist
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.
Interventions
DRUGTM30339 and/or placebo
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.
Sponsors
7TM Pharma A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
Outcome results
None listed