ObesityPhase 2NCT01818921
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
A Phase 2 study testing ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension and 1.8 mg ZGN-440 for injectable suspension in people with Obesity and Over-weight, run by Zafgen, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Obesity, Over-weight, Prader-Willi Syndrome
- What is being tested?
- ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension and 1.8 mg 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Nov 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
- BMI ≥25 kg/m2
- Type 2 diabetes mellitus is allowed
- Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
- Stable body weight during the past 3 months, except for during home visits
Who cannot join
- Use of weight loss agents in the past 3 months
- Type 1 diabetes mellitus
- Current or anticipated chronic use of narcotics or opiates
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32610-0296
About this study
Official title: Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
- Conditions
- Obesity, Over-weight, Prader-Willi Syndrome
- Being tested
- ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension, 1.8 mg ZGN-440 for injectable suspension
- Keywords
- Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433
- Medical subject headings
- Obesity, Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGN-440 sterile diluentDrug
Also called Placebo
ZGN-440 sterile diluent/placebo
1.2 mg ZGN-440 for injectable suspensionDrug
Also called ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib
1.2 mg beloranib
1.8 mg ZGN-440 for injectable suspensionDrug
Also called ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib
1.8 mg beloranib
| Study group | Role | What they receive |
|---|---|---|
| ZGN-440 sterile diluent | Placebo comparator | Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks. Receives: Drug: ZGN-440 sterile diluent |
| 1.2 mg ZGN-440 for injectable suspension | Experimental | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. Receives: Drug: 1.2 mg ZGN-440 for injectable suspension |
| 1.8 mg ZGN-440 for injectable suspension | Experimental | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. Receives: Drug: 1.8 mg ZGN-440 for injectable suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline to the end of the randomized dosing period.
Measured: 4 weeks
Secondary outcomes (2)
Change in body weight (kg) from baseline to the end of the randomized dosing period
Measured: 4 weeks
Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zafgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Miller, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818921
- Sponsor's protocol ID
- ZAF-211
- Status last verified
- Jul 2016
- First submitted
- 21 Mar 2013
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension
- ClinicalTrials.gov ID
- NCT01818921
- Acronym / sponsor ID
- ZAF-211
- Conditions
- Obesity, Over-weight, Prader-Willi Syndrome
- Keywords
- Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Zafgen, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Mar 2013 (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 the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZGN-440 sterile diluent | Placebo comparator | Drug: ZGN-440 sterile diluentSubjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks. |
| 1.2 mg ZGN-440 for injectable suspension | Experimental | Drug: 1.2 mg ZGN-440 for injectable suspensionSubjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
| 1.8 mg ZGN-440 for injectable suspension | Experimental | Drug: 1.8 mg ZGN-440 for injectable suspensionSubjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
- BMI ≥25 kg/m2
- Type 2 diabetes mellitus is allowed
- Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
- Stable body weight during the past 3 months, except for during home visits
Key exclusion criteria (3 listed)
- Use of weight loss agents in the past 3 months
- Type 1 diabetes mellitus
- Current or anticipated chronic use of narcotics or opiates
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 sterile diluentAlso: PlaceboZGN-440 sterile diluent/placebo | Drug | ZGN-440 sterile diluent |
| 1.2 mg ZGN-440 for injectable suspensionAlso: ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib1.2 mg beloranib | Drug | 1.2 mg ZGN-440 for injectable suspension |
| 1.8 mg ZGN-440 for injectable suspensionAlso: ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib1.8 mg beloranib | Drug | 1.8 mg ZGN-440 for injectable suspension |
Primary outcome
Percent change in body weight from baseline to the end of the randomized dosing period.
Time frame: 4 weeks
2 secondary outcomes
Change in body weight (kg) from baseline to the end of the randomized dosing period
Time frame: 4 weeks
Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire
Time frame: 4 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 18 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.
Jennifer Miller, MD principal investigator
University of Florida
1 site 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 sterile diluent, 1.2 mg ZGN-440 for injectable suspension and 1.8 mg ZGN-440 for injectable suspension in people with Obesity and Over-weight, run by Zafgen, Inc. at 1 site in United States.
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 5 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 18 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 1 site in United States. 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?
Percent change in body weight from baseline to the end of the randomized dosing period. (time frame: 4 weeks). 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 18 Jul 2016.