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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03254368




Registration number
NCT03254368
Ethics application status
Date submitted
7/08/2017
Date registered
18/08/2017
Date last updated
24/05/2019

Titles & IDs
Public title
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Scientific 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
Secondary ID [1] 0 0
U1111-1196-7527
Secondary ID [2] 0 0
ZAF-1061-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Overweight and Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZGN-1061
Treatment: Drugs - Placebo

Experimental: 0.05 mg ZGN-1061 (A) - 0.05 mg ZGN-1061 subcutaneous injection once every 3 days

Experimental: 0.3 mg ZGN-1061 (B) - 0.3 mg ZGN-1061 subcutaneous injection once every 3 days

Experimental: 0.9 mg ZGN-1061 (C) - 0.9 mg ZGN-1061 subcutaneous injection once every 3 days

Experimental: 1.8 mg ZGN-1061 (CC) - 1.8 mg ZGN-1061 subcutaneous injection once every 3 days

Placebo comparator: Placebo (D) - Placebo subcutaneous injection once every 3 days


Treatment: Drugs: ZGN-1061
ZGN-1061 is a methionine aminopeptidase 2 inhibitor

Treatment: Drugs: Placebo
Placebo has the same excipients and appearance as ZGN-1061
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Safety and tolerability as assessed by incidence of adverse events
Timepoint [2] 0 0
12 weeks
Primary outcome [3] 0 0
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Change in body weight
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Change in fasting plasma glucose
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Change in insulin
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Change in C-peptide
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change in proinsulin
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Change in glucagon
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Proportion of subjects achieving HbA1c <7% and =6.5%
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Change in beta-cell function
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Change in insulin sensitivity
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Change in waist and hip circumference
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Change in biomarkers relevant to obesity and/or type 2 diabetes
Timepoint [12] 0 0
12 weeks
Secondary outcome [13] 0 0
Change in patient reported outcomes measures
Timepoint [13] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2019
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Coffs Harbour GP SuperClinic - Coffs Harbour
Recruitment hospital [2] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [3] 0 0
The Aim Centre - Merewether
Recruitment hospital [4] 0 0
The Boden Institute - Sydney
Recruitment hospital [5] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [6] 0 0
Pendlebury Research - Sydney
Recruitment hospital [7] 0 0
Q-Pharm - Herston
Recruitment hospital [8] 0 0
Griffith University, Gold Coast Campus - Southport
Recruitment hospital [9] 0 0
Southern Adelaide Diabetes & Endocrine Services - Daw Park
Recruitment hospital [10] 0 0
Eastern Clinical Research Unit (ECRU) - Box Hill
Recruitment hospital [11] 0 0
Barwon Health - Geelong
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2006 - Sydney
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2289 - Sydney
Recruitment postcode(s) [6] 0 0
4006 - Herston
Recruitment postcode(s) [7] 0 0
4222 - Southport
Recruitment postcode(s) [8] 0 0
5041 - Daw Park
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3218 - Geelong
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hastings
Country [5] 0 0
New Zealand
State/province [5] 0 0
Newtown
Country [6] 0 0
New Zealand
State/province [6] 0 0
Rotorua
Country [7] 0 0
New Zealand
State/province [7] 0 0
Tauranga
Country [8] 0 0
New Zealand
State/province [8] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zafgen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT03254368
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dennis Kim, MD
Address 0 0
Zafgen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03254368