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Clinical Trial Details

Trial ID: L2167
Source ID: NCT02324491
Associated Drug: Zgn-440 For Injectable Suspension
Title: An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Obesity|Type 2 Diabetes
Interventions: DRUG: ZGN-440 for Injectable Suspension|DRUG: ZGN-440 Placebo for Injectable Suspension
Outcome Measures: Primary: 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 | Secondary: Change in body weight, Baseline to Week 52|Change in fasting glycemic parameters, HbA1c, plasma glucose, Baseline to Week 26 and Week 52|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
Sponsor/Collaborators: Sponsor: Zafgen, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 152
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-12
Completion Date: 2015-12
Results First Posted:
Last Update Posted: 2016-01-06
Locations: Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia|Pendlebury Research, 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
URL: https://clinicaltrials.gov/show/NCT02324491