ObesityPhase 2NCT02324491
An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
A Phase 2 study testing ZGN-440 for Injectable Suspension in people with Obesity and Type 2 Diabetes, run by Zafgen, Inc. at 16 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- ZGN-440 for Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 16 sitesAustralia
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Australia16 sites
CMAX
Adelaide, South Australia, 5000
Box Hill Hospital
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Pendlebury Research
Cardiff, New South Wales, 2285
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Barwon Health
Geelong, Victoria, 3220
Austin Health
Heidelberg West, Victoria, 3081
Q-Pharm
Herston, Queensland, 4006
Ipswich Research Institute
Ipswich, Queensland, 4305
Emeritus Research
Malvern East, Victoria, 3145
Australian Clinical Research Network
Maroubra, New South Wales, 2035
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, 3004
Keogh Institute for Medical Research
Nedlands, Western Australia, 6009
AusTrials
Sherwood, Queensland, 4075
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Illawara Diabetes Service
Wollongong, New South Wales, 2500
About this study
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
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.
Read the detailed description
Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- ZGN-440 for Injectable Suspension, ZGN-440 Placebo for Injectable Suspension
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGN-440 for Injectable SuspensionDrug
Also called Beloranib, ZGN-440
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
ZGN-440 Placebo for Injectable SuspensionDrug
Also called Placebo
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ZGN-440 Injectable Suspension (1.2mg) | Experimental | ZGN-440 for Injectable Suspension Receives: Drug: ZGN-440 for Injectable Suspension |
| ZGN-440 Injectable Suspension (1.8mg) | Experimental | ZGN-440 for Injectable Suspension Receives: Drug: ZGN-440 for Injectable Suspension |
| Placebo | Placebo comparator | ZGN-440 Placebo for Injectable Suspension Receives: Drug: ZGN-440 Placebo for Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline to Week 26
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
Measured: Baseline to Week 26 and Week 52
Secondary outcomes (4)
Change in body weight
Measured: Baseline to Week 52
Change in fasting glycemic parameters
HbA1c, plasma glucose
Measured: Baseline to Week 26 and Week 52
Change in cardiometabolic parameters
Blood pressure, lipid concentrations, hs-CRP
Measured: Baseline to Week 26 and Week 52
Change in Patient Reported Outcomes (PRO) scores
Measured: Baseline to Week 26 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Sponsor decision to analyze available safety and efficacy data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zafgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Kim, MD, Study director, Zafgen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324491
- Sponsor's protocol ID
- ZAF-203
- Status last verified
- Jan 2016
- First submitted
- 18 Dec 2014
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29992370
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02324491
- Acronym / sponsor ID
- ZAF-203
- Conditions
- Obesity, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to analyze available safety and efficacy data
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Zafgen, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZGN-440 Injectable Suspension (1.2mg) | Experimental | Drug: ZGN-440 for Injectable SuspensionZGN-440 for Injectable Suspension |
| ZGN-440 Injectable Suspension (1.8mg) | Experimental | Drug: ZGN-440 for Injectable SuspensionZGN-440 for Injectable Suspension |
| Placebo | Placebo comparator | Drug: ZGN-440 Placebo for Injectable SuspensionZGN-440 Placebo for Injectable Suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZGN-440 for Injectable SuspensionAlso: Beloranib, ZGN-440Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks. | Drug | ZGN-440 Injectable Suspension (1.2mg), ZGN-440 Injectable Suspension (1.8mg) |
| ZGN-440 Placebo for Injectable SuspensionAlso: PlaceboSubjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks. | Drug | Placebo |
Primary outcome
Change in body weight
Time frame: Baseline to Week 26
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
Time frame: Baseline to Week 26 and Week 52
4 secondary outcomes
Change in body weight
Time frame: Baseline to Week 52
Change in fasting glycemic parameters
Time frame: Baseline to Week 26 and Week 52
Change in cardiometabolic parameters
Time frame: Baseline to Week 26 and Week 52
Change in Patient Reported Outcomes (PRO) scores
Time frame: Baseline to Week 26 and Week 52
Results and safety
The study was stopped early (reason given: Sponsor decision to analyze available safety and efficacy data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Derived from this study: PubMed 29992370Proietto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Kim, MD study director
Zafgen, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZGN-440 for Injectable Suspension in people with Obesity and Type 2 Diabetes, run by Zafgen, Inc. at 16 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to analyze available safety and efficacy data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline to Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.