Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
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
2 other identifiers
interventional
188
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Sep 2017
Typical duration for phase_2 type-2-diabetes-mellitus
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedStudy Start
First participant enrolled
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2019
CompletedMay 24, 2019
May 1, 2019
1.2 years
August 7, 2017
May 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in HbA1c
12 weeks
Safety and tolerability as assessed by incidence of adverse events
12 weeks
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
12 weeks
Secondary Outcomes (13)
Change in body weight
12 weeks
Change in fasting plasma glucose
12 weeks
Change in insulin
12 weeks
Change in C-peptide
12 weeks
Change in proinsulin
12 weeks
- +8 more secondary outcomes
Study Arms (5)
0.05 mg ZGN-1061 (A)
EXPERIMENTAL0.05 mg ZGN-1061 subcutaneous injection once every 3 days
0.3 mg ZGN-1061 (B)
EXPERIMENTAL0.3 mg ZGN-1061 subcutaneous injection once every 3 days
0.9 mg ZGN-1061 (C)
EXPERIMENTAL0.9 mg ZGN-1061 subcutaneous injection once every 3 days
1.8 mg ZGN-1061 (CC)
EXPERIMENTAL1.8 mg ZGN-1061 subcutaneous injection once every 3 days
Placebo (D)
PLACEBO COMPARATORPlacebo subcutaneous injection once every 3 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zafgen, Inc.lead
Study Sites (23)
Coffs Harbour GP SuperClinic
Coffs Harbour, New South Wales, 2450, Australia
Northside Health
Coffs Harbour, New South Wales, 2450, Australia
The Aim Centre
Merewether, New South Wales, 2291, Australia
The Boden Institute
Sydney, New South Wales, 2006, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, 2010, Australia
Pendlebury Research
Sydney, New South Wales, 2289, Australia
Q-Pharm
Herston, Queensland, 4006, Australia
Griffith University, Gold Coast Campus
Southport, Queensland, 4222, Australia
Southern Adelaide Diabetes & Endocrine Services
Daw Park, South Australia, 5041, Australia
Eastern Clinical Research Unit (ECRU)
Box Hill, Victoria, 3128, Australia
Barwon Health
Geelong, Victoria, 3218, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Optimal Clinical Trials
Auckland, 1021, New Zealand
Middlemore Hospital
Auckland, 2025, New Zealand
Christchurch Diabetes Centre
Christchurch, 8011, New Zealand
Southern Clinical Trials
Christchurch, 8024, New Zealand
Lipid and Diabetes Research Group
Christchurch, 8140, New Zealand
Clinical Trials New Zealand Ltd
Hamilton, 3206, New Zealand
P3 Research Hawkes Bay
Hastings, 4130, New Zealand
P3 Research Wellington
Newtown, 6021, New Zealand
Lakeland Clinical Trials
Rotorua, 3010, New Zealand
P3 Research Tauranga
Tauranga, 3110, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dennis Kim, MD
Zafgen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2017
First Posted
August 18, 2017
Study Start
September 12, 2017
Primary Completion
November 12, 2018
Study Completion
February 22, 2019
Last Updated
May 24, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share