ObesityPhase 2NCT01666691
An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects
A Phase 2 study testing Beloranib in people with Obesity, run by Zafgen, Inc. at 3 sites in Australia.
Trial summary
The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Beloranib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesAustralia
- Study dates
- Aug 2012to May 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese volunteers weighing ≥ 50 kg
- BMI ≥ 30 and ≤ 50 kg/m2
- Stable body weight during the past 2 months
- Type 2 diabetes mellitus is allowed
Who cannot join
- Use of weight loss agents in the past month
- Current, clinically significant eating disorder
- Type 1 diabetes mellitus
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
CMAX
Adelaide, South Australia, 5000
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland
Linear Clinical Research Ltd
Perth, Western Australia, 6009
About this study
Official title: Randomized, Double-Blind, Placebo Controlled, Dose Ranging Phase 2 Trial of Beloranib (ZGN-440 for Injectable Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects to Evaluate Weight Reduction, Safety, and Pharmacokinetics Over 12 Weeks
The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.
Read the detailed description
This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.
- Conditions
- Obesity
- Being tested
- Beloranib, Placebo
- Keywords
- Obese, Obesity, Overweight, Weight loss, Weight reduction, Beloranib
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeloranibDrug
Also called ZGN-440 for injectable suspension, ZGN-440, ZGN-433
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
PlaceboDrug
Also called ZGN-440 sterile diluent
Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | ZGN-440 sterile diluent Receives: Drug: Placebo |
| 0.3 mg Beloranib | Experimental | 0.3 mg ZGN-440 for injectable suspension Receives: Drug: Beloranib |
| 0.6 mg Beloranib | Experimental | 0.6 mg ZGN-440 for injectable suspension Receives: Drug: Beloranib |
| 1.2 mg Beloranib | Experimental | 1.2 mg ZGN-440 for injectable suspension Receives: Drug: Beloranib |
| 2.4 mg Beloranib | Experimental | 2.4 mg ZGN-440 for injectable suspension Receives: Drug: Beloranib |
| 3.2 mg Beloranib | Experimental | 3.2 mg ZGN-440 for injectable suspension Receives: Drug: Beloranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.
Measured: Up to 26 weeks
Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440
Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.
Measured: Up to 13 weeks
Secondary outcomes (3)
Pharmacodynamics over a dose range of beloranib
The plasma PK of beloranib and selected metabolites may be assessed following dose administration to compare systemic exposure and PK parameters over the range of doses. PK parameters include Cmax, Tmax, AUC24hour, AUC∞, volume of distribution, total clearance, terminal elimination constant, and half-life. Mean residence time may also be reported.
Measured: Up to 12 weeks
Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously
Measured: Up to 12 weeks
Apparent bioavailability over a dose range of beloranib
Bioavailability will be estimated from the SC PK parameters compared to the profile from comparable doses in earlier IV administration studies.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zafgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J K Marjason, MD, Principal investigator, Q-Pharm Clinics, Royal Brisbane and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666691
- Sponsor's protocol ID
- ZAF-201
- Status last verified
- Jul 2016
- First submitted
- 8 Aug 2012
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo Controlled, Dose Ranging Phase 2 Trial of Beloranib (ZGN-440 for Injectable Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects to Evaluate Weight Reduction, Safety, and Pharmacokinetics Over 12 Weeks
- ClinicalTrials.gov ID
- NCT01666691
- Acronym / sponsor ID
- ZAF-201
- Conditions
- Obesity
- Keywords
- Obese, Obesity, Overweight, Weight loss, Weight reduction, Beloranib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zafgen, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Aug 2012 (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 weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.
Detailed description
This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboZGN-440 sterile diluent |
| 0.3 mg Beloranib | Experimental | Drug: Beloranib0.3 mg ZGN-440 for injectable suspension |
| 0.6 mg Beloranib | Experimental | Drug: Beloranib0.6 mg ZGN-440 for injectable suspension |
| 1.2 mg Beloranib | Experimental | Drug: Beloranib1.2 mg ZGN-440 for injectable suspension |
| 2.4 mg Beloranib | Experimental | Drug: Beloranib2.4 mg ZGN-440 for injectable suspension |
| 3.2 mg Beloranib | Experimental | Drug: Beloranib3.2 mg ZGN-440 for injectable suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obese volunteers weighing ≥ 50 kg
- BMI ≥ 30 and ≤ 50 kg/m2
- Stable body weight during the past 2 months
- Type 2 diabetes mellitus is allowed
Key exclusion criteria (3 listed)
- Use of weight loss agents in the past month
- Current, clinically significant eating disorder
- Type 1 diabetes mellitus
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 |
|---|---|---|
| BeloranibAlso: ZGN-440 for injectable suspension, ZGN-440, ZGN-433Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated. | Drug | 0.3 mg Beloranib, 0.6 mg Beloranib, 1.2 mg Beloranib, 2.4 mg Beloranib, 3.2 mg Beloranib |
| PlaceboAlso: ZGN-440 sterile diluentSubjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. | Drug | Placebo |
Primary outcome
Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks
Time frame: Up to 26 weeks
Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.
Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440
Time frame: Up to 13 weeks
Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.
3 secondary outcomes
Pharmacodynamics over a dose range of beloranib
Time frame: Up to 12 weeks
Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously
Time frame: Up to 12 weeks
Apparent bioavailability over a dose range of beloranib
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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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.
J K Marjason, MD principal investigator
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
3 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 Beloranib in people with Obesity, run by Zafgen, Inc. at 3 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 4 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: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks (time frame: Up to 26 weeks). 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?
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 14 Jul 2016.