Study Stopped
Sponsor decision to analyze available safety and efficacy data
An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Weight Reduction, Glycemic Control, Safety, and Tolerability
1 other identifier
interventional
152
1 country
16
Brief Summary
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Dec 2014
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 6, 2016
January 1, 2016
1 year
December 18, 2014
January 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Change in body weight
Baseline to Week 52
Change in fasting glycemic parameters
Baseline to Week 26 and Week 52
Change in cardiometabolic parameters
Baseline to Week 26 and Week 52
Change in Patient Reported Outcomes (PRO) scores
Baseline to Week 26 and Week 52
Study Arms (3)
ZGN-440 Injectable Suspension (1.2mg)
EXPERIMENTALZGN-440 for Injectable Suspension
ZGN-440 Injectable Suspension (1.8mg)
EXPERIMENTALZGN-440 for Injectable Suspension
Placebo
PLACEBO COMPARATORZGN-440 Placebo for Injectable Suspension
Interventions
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Eligibility Criteria
You may qualify if:
- Obese with BMI ≥30 kg/m2
- Type 2 diabetes mellitus
- HbA1c of 7-11%
- Fasting glucose \<15.5 mmol/L
- Treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, SGLT-2 inhibitor or any combination of these agents
- Female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive
You may not qualify if:
- Current or recent use of insulin
- Severe hypoglycemia within the prior 6 months
- Metabolic disorders or genetic disorders linked to obesity (e.g., Prader-Willi Syndrome)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zafgen, Inc.lead
Study Sites (16)
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
Related Publications (1)
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.
PMID: 29992370DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dennis Kim, MD
Zafgen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2014
First Posted
December 24, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 6, 2016
Record last verified: 2016-01