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Sponsor decision to analyze available safety and efficacy data
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The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.
Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZGN-440 Injectable Suspension (1.2mg) | Experimental | ZGN-440 for Injectable Suspension |
|
| ZGN-440 Injectable Suspension (1.8mg) | Experimental | ZGN-440 for Injectable Suspension |
|
| Placebo | Placebo Comparator | ZGN-440 Placebo for Injectable Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZGN-440 for Injectable Suspension | Drug | Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline to Week 26 | |
| Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations | Baseline to Week 26 and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline to Week 52 | |
| Change in fasting glycemic parameters | HbA1c, plasma glucose | Baseline to Week 26 and Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Kim, MD | Zafgen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Pendlebury Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29992370 | Derived | Proietto J, Malloy J, Zhuang D, Arya M, Cohen ND, de Looze FJ, Gilfillan C, Griffin P, Hall S, Nathow T, Oldfield GS, O'Neal DN, Roberts A, Stuckey BGA, Yue D, Taylor K, Kim D. Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial. Diabetologia. 2018 Sep;61(9):1918-1922. doi: 10.1007/s00125-018-4677-0. Epub 2018 Jul 11. |
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|
| ZGN-440 Placebo for Injectable Suspension | Drug | Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks. |
|
|
| Change in cardiometabolic parameters | Blood pressure, lipid concentrations, hs-CRP | Baseline to Week 26 and Week 52 |
| Change in Patient Reported Outcomes (PRO) scores | Baseline to Week 26 and Week 52 |
| Cardiff |
| New South Wales |
| 2285 |
| Australia |
| Australian Clinical Research Network | Maroubra | New South Wales | 2035 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Illawara Diabetes Service | Wollongong | New South Wales | 2500 | Australia |
| Q-Pharm | Herston | Queensland | 4006 | Australia |
| Ipswich Research Institute | Ipswich | Queensland | 4305 | Australia |
| AusTrials | Sherwood | Queensland | 4075 | Australia |
| CMAX | Adelaide | South Australia | 5000 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| St. Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| Barwon Health | Geelong | Victoria | 3220 | Australia |
| Austin Health | Heidelberg West | Victoria | 3081 | Australia |
| Emeritus Research | Malvern East | Victoria | 3145 | Australia |
| Baker IDI Heart and Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
| Keogh Institute for Medical Research | Nedlands | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C487952 | CKD732 |
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