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

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

Detailed Description
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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.

Official Title
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TM30339: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Repeated Subcutaneous Dose-range Study Designed to Determine the Weight Loss in Obese Subjects.

Conditions
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Obesity

Intervention / Treatment
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* Drug: TM30339 and/or placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AM dose: 0.85 mg PM dose: placebo | Drug: TM30339 and/or placebo<br>* 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.<br>* Other names: 30339;|
| Experimental: 2<br>AM dose: 0.85 mg PM dose: 0.85 mg | Drug: TM30339 and/or placebo<br>* 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.<br>* Other names: 30339;|
| Experimental: 3<br>AM dose: 2.55 mg PM dose: placebo | Drug: TM30339 and/or placebo<br>* 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.<br>* Other names: 30339;|
| Experimental: 4<br>AM dose: placebo PM dose: 2.55 mg | Drug: TM30339 and/or placebo<br>* 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.<br>* Other names: 30339;|
| Experimental: 5<br>AM dose: 2.55 mg PM dose: 2.55 mg | Drug: TM30339 and/or placebo<br>* 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.<br>* Other names: 30339;|
| Experimental: 6<br>AM dose: placebo PM dose: placebo | Drug: TM30339 and/or placebo<br>* 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.<br>* Other names: 30339;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, weight loss, 7TM Pharma, TM30339, Y4 receptor antagonist