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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1196-7527 | Registry Identifier | International Clinical Trials Registry Platform |
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The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.05 mg ZGN-1061 (A) | Experimental | 0.05 mg ZGN-1061 subcutaneous injection once every 3 days |
|
| 0.3 mg ZGN-1061 (B) | Experimental | 0.3 mg ZGN-1061 subcutaneous injection once every 3 days |
|
| 0.9 mg ZGN-1061 (C) | Experimental | 0.9 mg ZGN-1061 subcutaneous injection once every 3 days |
|
| 1.8 mg ZGN-1061 (CC) | Experimental | 1.8 mg ZGN-1061 subcutaneous injection once every 3 days |
|
| Placebo (D) | Placebo Comparator | Placebo subcutaneous injection once every 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZGN-1061 | Drug | ZGN-1061 is a methionine aminopeptidase 2 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 12 weeks | |
| Safety and tolerability as assessed by incidence of adverse events | 12 weeks | |
| Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | 12 weeks | |
| Change in fasting plasma glucose | 12 weeks | |
| Change in insulin |
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Inclusion Criteria:
Subjects must meet the following criteria to participate in this study:
Exclusion Criteria:
Subjects cannot participate in this research study if they meet any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Kim, MD | Zafgen, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coffs Harbour GP SuperClinic | Coffs Harbour | New South Wales | 2450 | Australia | ||
| Northside Health |
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| Placebo | Drug | Placebo has the same excipients and appearance as ZGN-1061 |
|
| 12 weeks |
| Change in C-peptide | 12 weeks |
| Change in proinsulin | 12 weeks |
| Change in glucagon | 12 weeks |
| Proportion of subjects achieving HbA1c <7% and ≤6.5% | 12 weeks |
| Change in beta-cell function | 12 weeks |
| Change in insulin sensitivity | 12 weeks |
| Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects | 12 weeks |
| Change in waist and hip circumference | 12 weeks |
| Change in biomarkers relevant to obesity and/or type 2 diabetes | 12 weeks |
| Change in patient reported outcomes measures | 12 weeks |
| Coffs Harbour |
| New South Wales |
| 2450 |
| Australia |
| The Aim Centre | Merewether | New South Wales | 2291 | Australia |
| The Boden Institute | Sydney | New South Wales | 2006 | Australia |
| Holdsworth House Medical Practice | Sydney | New South Wales | 2010 | Australia |
| Pendlebury Research | Sydney | New South Wales | 2289 | Australia |
| Q-Pharm | Herston | Queensland | 4006 | Australia |
| Griffith University, Gold Coast Campus | Southport | Queensland | 4222 | Australia |
| Southern Adelaide Diabetes & Endocrine Services | Daw Park | South Australia | 5041 | Australia |
| Eastern Clinical Research Unit (ECRU) | Box Hill | Victoria | 3128 | Australia |
| Barwon Health | Geelong | Victoria | 3218 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Optimal Clinical Trials | Auckland | 1021 | New Zealand |
| Middlemore Hospital | Auckland | 2025 | New Zealand |
| Christchurch Diabetes Centre | Christchurch | 8011 | New Zealand |
| Southern Clinical Trials | Christchurch | 8024 | New Zealand |
| Lipid and Diabetes Research Group | Christchurch | 8140 | New Zealand |
| Clinical Trials New Zealand Ltd | Hamilton | 3206 | New Zealand |
| P3 Research Hawkes Bay | Hastings | 4130 | New Zealand |
| P3 Research Wellington | Newtown | 6021 | New Zealand |
| Lakeland Clinical Trials | Rotorua | 3010 | New Zealand |
| P3 Research Tauranga | Tauranga | 3110 | New Zealand |
| Wellington Hospital | Wellington | 6021 | New Zealand |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629660 | ZGN-1061 |
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