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Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus, Overweight and Obesity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZGN-1061
Placebo
Sponsored by
Zafgen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Methionine Aminopeptidase 2 Inhibitor, Diabetes Mellitus, Type 2, Blood Glucose, Overweight, Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must meet the following criteria to participate in this study:

  • Be between the ages of 18 and 70 years, inclusive.
  • Overweight or obese with a body mass index of at least 27 kg/m².
  • Have type 2 diabetes with HbA1c between 7% and 11%.
  • For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
  • For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.

Exclusion Criteria:

Subjects cannot participate in this research study if they meet any of the following:

  • Have taken another study drug or study device within the past 6 months.
  • Are taking certain prescribed medications including narcotics or opiates.
  • Consistent recent use of insulin.
  • Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
  • Have a history of bleeding disorders or risk factors for excessive blood clotting.
  • Have difficulty giving blood.
  • Have a history of drug and/or alcohol abuse.

Sites / Locations

  • Coffs Harbour GP SuperClinic
  • Northside Health
  • The Aim Centre
  • The Boden Institute
  • Holdsworth House Medical Practice
  • Pendlebury Research
  • Q-Pharm
  • Griffith University, Gold Coast Campus
  • Southern Adelaide Diabetes & Endocrine Services
  • Eastern Clinical Research Unit (ECRU)
  • Barwon Health
  • Royal Melbourne Hospital
  • Optimal Clinical Trials
  • Middlemore Hospital
  • Christchurch Diabetes Centre
  • Southern Clinical Trials
  • Lipid and Diabetes Research Group
  • Clinical Trials New Zealand Ltd
  • P3 Research Hawkes Bay
  • P3 Research Wellington
  • Lakeland Clinical Trials
  • P3 Research Tauranga
  • Wellington Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

0.05 mg ZGN-1061 (A)

0.3 mg ZGN-1061 (B)

0.9 mg ZGN-1061 (C)

1.8 mg ZGN-1061 (CC)

Placebo (D)

Arm Description

0.05 mg ZGN-1061 subcutaneous injection once every 3 days

0.3 mg ZGN-1061 subcutaneous injection once every 3 days

0.9 mg ZGN-1061 subcutaneous injection once every 3 days

1.8 mg ZGN-1061 subcutaneous injection once every 3 days

Placebo subcutaneous injection once every 3 days

Outcomes

Primary Outcome Measures

Change in HbA1c
Safety and tolerability as assessed by incidence of adverse events
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results

Secondary Outcome Measures

Change in body weight
Change in fasting plasma glucose
Change in insulin
Change in C-peptide
Change in proinsulin
Change in glucagon
Proportion of subjects achieving HbA1c <7% and ≤6.5%
Change in beta-cell function
Change in insulin sensitivity
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Change in waist and hip circumference
Change in biomarkers relevant to obesity and/or type 2 diabetes
Change in patient reported outcomes measures

Full Information

First Posted
August 7, 2017
Last Updated
May 22, 2019
Sponsor
Zafgen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03254368
Brief Title
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Official Title
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
November 12, 2018 (Actual)
Study Completion Date
February 22, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
Detailed Description
Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight and Obesity
Keywords
Methionine Aminopeptidase 2 Inhibitor, Diabetes Mellitus, Type 2, Blood Glucose, Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.05 mg ZGN-1061 (A)
Arm Type
Experimental
Arm Description
0.05 mg ZGN-1061 subcutaneous injection once every 3 days
Arm Title
0.3 mg ZGN-1061 (B)
Arm Type
Experimental
Arm Description
0.3 mg ZGN-1061 subcutaneous injection once every 3 days
Arm Title
0.9 mg ZGN-1061 (C)
Arm Type
Experimental
Arm Description
0.9 mg ZGN-1061 subcutaneous injection once every 3 days
Arm Title
1.8 mg ZGN-1061 (CC)
Arm Type
Experimental
Arm Description
1.8 mg ZGN-1061 subcutaneous injection once every 3 days
Arm Title
Placebo (D)
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous injection once every 3 days
Intervention Type
Drug
Intervention Name(s)
ZGN-1061
Intervention Description
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo has the same excipients and appearance as ZGN-1061
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
12 weeks
Title
Safety and tolerability as assessed by incidence of adverse events
Time Frame
12 weeks
Title
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
12 weeks
Title
Change in fasting plasma glucose
Time Frame
12 weeks
Title
Change in insulin
Time Frame
12 weeks
Title
Change in C-peptide
Time Frame
12 weeks
Title
Change in proinsulin
Time Frame
12 weeks
Title
Change in glucagon
Time Frame
12 weeks
Title
Proportion of subjects achieving HbA1c <7% and ≤6.5%
Time Frame
12 weeks
Title
Change in beta-cell function
Time Frame
12 weeks
Title
Change in insulin sensitivity
Time Frame
12 weeks
Title
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Time Frame
12 weeks
Title
Change in waist and hip circumference
Time Frame
12 weeks
Title
Change in biomarkers relevant to obesity and/or type 2 diabetes
Time Frame
12 weeks
Title
Change in patient reported outcomes measures
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet the following criteria to participate in this study: Be between the ages of 18 and 70 years, inclusive. Overweight or obese with a body mass index of at least 27 kg/m². Have type 2 diabetes with HbA1c between 7% and 11%. For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor. For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery. Exclusion Criteria: Subjects cannot participate in this research study if they meet any of the following: Have taken another study drug or study device within the past 6 months. Are taking certain prescribed medications including narcotics or opiates. Consistent recent use of insulin. Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study. Have a history of bleeding disorders or risk factors for excessive blood clotting. Have difficulty giving blood. Have a history of drug and/or alcohol abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Kim, MD
Organizational Affiliation
Zafgen, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Coffs Harbour GP SuperClinic
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Northside Health
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
The Aim Centre
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Facility Name
The Boden Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Pendlebury Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2289
Country
Australia
Facility Name
Q-Pharm
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Griffith University, Gold Coast Campus
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Southern Adelaide Diabetes & Endocrine Services
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Eastern Clinical Research Unit (ECRU)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3218
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Optimal Clinical Trials
City
Auckland
ZIP/Postal Code
1021
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Christchurch Diabetes Centre
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Southern Clinical Trials
City
Christchurch
ZIP/Postal Code
8024
Country
New Zealand
Facility Name
Lipid and Diabetes Research Group
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Clinical Trials New Zealand Ltd
City
Hamilton
ZIP/Postal Code
3206
Country
New Zealand
Facility Name
P3 Research Hawkes Bay
City
Hastings
ZIP/Postal Code
4130
Country
New Zealand
Facility Name
P3 Research Wellington
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Lakeland Clinical Trials
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
P3 Research Tauranga
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

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