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The trial is terminated due to re-evaluation of the compound
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This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0070-0002-0182 | Drug | 4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses | after 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of NNC 0070-0002-0182 and its isomer | at 8 weeks | |
| Assessment of changes in food consumption and hunger | at 6 weeks | |
| Change in weight, waist and hip measurements and mood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Evansville | Indiana | 47710 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Placebo for s.c. injection |
|
| NNC 0070-0002-0182 | Drug | 12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial |
|
| NNC 0070-0002-0182 | Drug | 32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial |
|
| NNC 0070-0002-0182 | Drug | 60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial |
|
| at 6 weeks |
| Change in body composition and resting metabolism | at 6 weeks |
| Intervention arm D only: Change in insulin sensitivity (HOMA) | at 6 weeks |
| Intervention arm D only: Change from baseline in body fat (DEXA) | at 6 weeks |
| Intervention arm D only: Change from baseline in indirect calorimetry | at 6 weeks |
| Intervention arm D only: Change from baseline in adiponectin, hsCRP | at 6 weeks |
| Intervention arm D only: Antibody assessment | at 10 weeks |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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