- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02324491
An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
January 4, 2016 updated by: Zafgen, Inc.
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
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
-
Cardiff, New South Wales, Australia, 2285
- Pendlebury Research
-
Maroubra, New South Wales, Australia, 2035
- Australian Clinical Research Network
-
St. Leonards, New South Wales, Australia, 2065
- Royal North Shore Hospital
-
Wollongong, New South Wales, Australia, 2500
- Illawara Diabetes Service
-
-
Queensland
-
Herston, Queensland, Australia, 4006
- Q-Pharm
-
Ipswich, Queensland, Australia, 4305
- Ipswich Research Institute
-
Sherwood, Queensland, Australia, 4075
- AusTrials
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX
-
-
Victoria
-
Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
-
Fitzroy, Victoria, Australia, 3065
- St. Vincent's Hospital
-
Geelong, Victoria, Australia, 3220
- Barwon Health
-
Heidelberg West, Victoria, Australia, 3081
- Austin Health
-
Malvern East, Victoria, Australia, 3145
- Emeritus Research
-
Melbourne, Victoria, Australia, 3004
- Baker IDI Heart and Diabetes Institute
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Keogh Institute for Medical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ZGN-440 Injectable Suspension (1.2mg)
ZGN-440 for Injectable Suspension
|
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
Other Names:
|
Experimental: ZGN-440 Injectable Suspension (1.8mg)
ZGN-440 for Injectable Suspension
|
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
Other Names:
|
Placebo Comparator: Placebo
ZGN-440 Placebo for Injectable Suspension
|
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body weight
Time Frame: Baseline to Week 26
|
Baseline to Week 26
|
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
Time Frame: Baseline to Week 26 and Week 52
|
Baseline to Week 26 and Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body weight
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
|
Change in fasting glycemic parameters
Time Frame: Baseline to Week 26 and Week 52
|
HbA1c, plasma glucose
|
Baseline to Week 26 and Week 52
|
Change in cardiometabolic parameters
Time Frame: Baseline to Week 26 and Week 52
|
Blood pressure, lipid concentrations, hs-CRP
|
Baseline to Week 26 and Week 52
|
Change in Patient Reported Outcomes (PRO) scores
Time Frame: Baseline to Week 26 and Week 52
|
Baseline to Week 26 and Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 18, 2014
First Submitted That Met QC Criteria
December 23, 2014
First Posted (Estimate)
December 24, 2014
Study Record Updates
Last Update Posted (Estimate)
January 6, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZAF-203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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