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An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Obesity, Type 2 Diabetes

Status
Terminated
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
ZGN-440 for Injectable Suspension
ZGN-440 Placebo for Injectable Suspension
Sponsored by
Zafgen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal Prince Alfred Hospital
  • Pendlebury Research
  • Australian Clinical Research Network
  • Royal North Shore Hospital
  • Illawara Diabetes Service
  • Q-Pharm
  • Ipswich Research Institute
  • AusTrials
  • CMAX
  • Box Hill Hospital
  • St. Vincent's Hospital
  • Barwon Health
  • Austin Health
  • Emeritus Research
  • Baker IDI Heart and Diabetes Institute
  • Keogh Institute for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ZGN-440 Injectable Suspension (1.2mg)

ZGN-440 Injectable Suspension (1.8mg)

Placebo

Arm Description

ZGN-440 for Injectable Suspension

ZGN-440 for Injectable Suspension

ZGN-440 Placebo for Injectable Suspension

Outcomes

Primary Outcome Measures

Change in body weight
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations

Secondary Outcome Measures

Change in body weight
Change in fasting glycemic parameters
HbA1c, plasma glucose
Change in cardiometabolic parameters
Blood pressure, lipid concentrations, hs-CRP
Change in Patient Reported Outcomes (PRO) scores

Full Information

First Posted
December 18, 2014
Last Updated
January 4, 2016
Sponsor
Zafgen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02324491
Brief Title
An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to analyze available safety and efficacy data
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zafgen, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZGN-440 Injectable Suspension (1.2mg)
Arm Type
Experimental
Arm Description
ZGN-440 for Injectable Suspension
Arm Title
ZGN-440 Injectable Suspension (1.8mg)
Arm Type
Experimental
Arm Description
ZGN-440 for Injectable Suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
ZGN-440 Placebo for Injectable Suspension
Intervention Type
Drug
Intervention Name(s)
ZGN-440 for Injectable Suspension
Other Intervention Name(s)
Beloranib, ZGN-440
Intervention Description
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
ZGN-440 Placebo for Injectable Suspension
Other Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to Week 26
Title
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
Time Frame
Baseline to Week 26 and Week 52
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to Week 52
Title
Change in fasting glycemic parameters
Description
HbA1c, plasma glucose
Time Frame
Baseline to Week 26 and Week 52
Title
Change in cardiometabolic parameters
Description
Blood pressure, lipid concentrations, hs-CRP
Time Frame
Baseline to Week 26 and Week 52
Title
Change in Patient Reported Outcomes (PRO) scores
Time Frame
Baseline to Week 26 and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Kim, MD
Organizational Affiliation
Zafgen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Pendlebury Research
City
Cardiff
State/Province
New South Wales
ZIP/Postal Code
2285
Country
Australia
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Illawara Diabetes Service
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Q-Pharm
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Ipswich Research Institute
City
Ipswich
State/Province
Queensland
ZIP/Postal Code
4305
Country
Australia
Facility Name
AusTrials
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
CMAX
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Health
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Emeritus Research
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Baker IDI Heart and Diabetes Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Keogh Institute for Medical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29992370
Citation
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.
Results Reference
derived

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An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus

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