Title
A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.
TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.
Phase
Phase 2Lead Sponsor
7TM Pharma A/SStudy Type
InterventionalStatus
TerminatedIndication/Condition
ObesityIntervention/Treatment
tm-30339 ...Study Participants
192The 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.
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.
Inclusion Criteria: Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive Age 18-60 years inclusive 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 Stable weight over past 2 months i.e. a change in body weight < 3 kg as reported by the subject Exclusion Criteria: Subjects with a history of allergies toward products containing natural rubber (e.g. latex) 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 Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes Subjects who have a QTc (Bazett's correction) interval of > 450 msec at screening Subjects with bradycardia (heart rate < 50) Subjects with heart block Clinically significant thyroid dysfunction as evidenced by TSH > 1.5 X ULN
