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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02324491




Registration number
NCT02324491
Ethics application status
Date submitted
18/12/2014
Date registered
24/12/2014
Date last updated
6/01/2016

Titles & IDs
Public title
An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
ZAF-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZGN-440 for Injectable Suspension
Treatment: Drugs - ZGN-440 Placebo for Injectable Suspension

Experimental: ZGN-440 Injectable Suspension (1.2mg) - ZGN-440 for Injectable Suspension

Experimental: ZGN-440 Injectable Suspension (1.8mg) - ZGN-440 for Injectable Suspension

Placebo Comparator: Placebo - ZGN-440 Placebo for Injectable Suspension


Treatment: Drugs: ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.

Treatment: Drugs: ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in body weight
Timepoint [1] 0 0
Baseline to Week 26
Primary outcome [2] 0 0
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
Timepoint [2] 0 0
Baseline to Week 26 and Week 52
Secondary outcome [1] 0 0
Change in body weight
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Change in fasting glycemic parameters
Timepoint [2] 0 0
Baseline to Week 26 and Week 52
Secondary outcome [3] 0 0
Change in cardiometabolic parameters
Timepoint [3] 0 0
Baseline to Week 26 and Week 52
Secondary outcome [4] 0 0
Change in Patient Reported Outcomes (PRO) scores
Timepoint [4] 0 0
Baseline to Week 26 and Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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 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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Pendlebury Research - Cardiff
Recruitment hospital [3] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
Illawara Diabetes Service - Wollongong
Recruitment hospital [6] 0 0
Q-Pharm - Herston
Recruitment hospital [7] 0 0
Ipswich Research Institute - Ipswich
Recruitment hospital [8] 0 0
AusTrials - Sherwood
Recruitment hospital [9] 0 0
CMAX - Adelaide
Recruitment hospital [10] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [11] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [12] 0 0
Barwon Health - Geelong
Recruitment hospital [13] 0 0
Austin Health - Heidelberg West
Recruitment hospital [14] 0 0
Emeritus Research - Malvern East
Recruitment hospital [15] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment hospital [16] 0 0
Keogh Institute for Medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2285 - Cardiff
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4006 - Herston
Recruitment postcode(s) [7] 0 0
4305 - Ipswich
Recruitment postcode(s) [8] 0 0
4075 - Sherwood
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [14] 0 0
3145 - Malvern East
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
6009 - Nedlands

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 efficacy and safety of ZGN-440 (beloranib) in obese
adult subjects with type 2 diabetes mellitus.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02324491
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/ct2/show/NCT02324491