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The IND was withdrawn.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AM dose: 0.85 mg PM dose: placebo |
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| 2 | Experimental | AM dose: 0.85 mg PM dose: 0.85 mg |
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| 3 | Experimental | AM dose: 2.55 mg PM dose: placebo |
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| 4 | Experimental | AM dose: placebo PM dose: 2.55 mg |
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| 5 | Experimental | AM dose: 2.55 mg PM dose: 2.55 mg |
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| 6 | Experimental | AM dose: placebo PM dose: placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TM30339 and/or placebo | Drug | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| 7TM Pharma website | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |