ObesityPhase 2NCT02063295
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
A Phase 2 study testing ZGN-440 sterile diluent and ZGN-440 for injectable suspension in people with Obesity and Over-weight, run by Zafgen, Inc. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Over-weight, Hypothalamic Injury
- What is being tested?
- ZGN-440 sterile diluent and 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
- 14 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2014to Nov 2014
- 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
- Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
- Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
- Stable body weight for at least 3 months
- Type 2 diabetes mellitus is allowed
Who cannot join
- Males taking gonadotropin replacement therapy (LH/FSH)
- Subjects who are planning any fertility treatment within 6 months of study participation
- Use of weight loss agents, including herbal medications, in the past 3 months
- Current or anticipated chronic use of narcotics or opiates
- History of severe psychiatric disorders
- Type 1 diabetes mellitus
Show all 11Show fewer
- Metabolic disorders or genetic disorders linked to obesity
- History of any bariatric surgery
- Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
- Blood loss or donation >500 mL within the past 3 months
- Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
Australia2 sites
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, 3081
The Boden Institute
Sydney, New South Wales, 2006
About this study
Official title: Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.
- Conditions
- Obesity, Over-weight, Hypothalamic Injury, Craniopharyngioma
- Being tested
- ZGN-440 sterile diluent, ZGN-440 for injectable suspension
- Keywords
- Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433
- Medical subject headings
- Obesity, Craniopharyngioma
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
ZGN-440 for injectable suspensionDrug
Also called ZGN-440, Beloranib
| Study group | Role | What they receive |
|---|---|---|
| ZGN-440 sterile diluent | Placebo comparator | Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks. Receives: Drug: ZGN-440 sterile diluent |
| 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: ZGN-440 for injectable suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline to the end of the randomized dosing period.
Measured: 4 weeks
Secondary outcomes (4)
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
Measured: 4 weeks
Change in hs-CRP from baseline to the end of the randomized dosing period.
Measured: 4 weeks
Change in hunger from baseline to the end of the randomized dosing period.
Measured: 4 weeks
Change in quality of life from baseline to the end of the randomized dosing period.
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 posted14 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zafgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063295
- Sponsor's protocol ID
- ZAF-221
- Status last verified
- Jul 2016
- First submitted
- 12 Feb 2014
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shoemaker A, Proietto J, Abuzzahab MJ, Markovic T, Malloy J, Kim DD. A randomized, placebo-controlled trial of beloranib for the treatment of hypothalamic injury-associated obesity. Diabetes Obes Metab. 2017 Aug;19(8):1165-1170. doi: 10.1111/dom.12928. Epub 2017 Apr 18.
PubMed 28261955
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, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension
- ClinicalTrials.gov ID
- NCT02063295
- Acronym / sponsor ID
- ZAF-221
- Conditions
- Obesity, Over-weight, Hypothalamic Injury, Craniopharyngioma
- Keywords
- Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Zafgen, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Feb 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 the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZGN-440 sterile diluent | Placebo comparator | Drug: ZGN-440 sterile diluentSubjects will receive placebo twice weekly subcutaneous injections for 4 weeks. |
| ZGN-440 for injectable suspension | Experimental | Drug: 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
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
- Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
- Stable body weight for at least 3 months
- Type 2 diabetes mellitus is allowed
Key exclusion criteria (11 listed)
- Males taking gonadotropin replacement therapy (LH/FSH)
- Subjects who are planning any fertility treatment within 6 months of study participation
- Use of weight loss agents, including herbal medications, in the past 3 months
- Current or anticipated chronic use of narcotics or opiates
- History of severe psychiatric disorders
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 |
| ZGN-440 for injectable suspensionAlso: ZGN-440, Beloranib | Drug | ZGN-440 for injectable suspension |
Primary outcome
Change in body weight from baseline to the end of the randomized dosing period.
Time frame: 4 weeks
4 secondary outcomes
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
Time frame: 4 weeks
Change in hs-CRP from baseline to the end of the randomized dosing period.
Time frame: 4 weeks
Change in hunger from baseline to the end of the randomized dosing period.
Time frame: 4 weeks
Change in quality of life from baseline to the end of the randomized dosing period.
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.
- Derived from this study: PubMed 28261955Shoemaker A, Proietto J, Abuzzahab MJ, Markovic T, Malloy J, Kim DD. A randomized, placebo-controlled trial of beloranib for the treatment of hypothalamic injury-associated obesity. Diabetes Obes Metab. 2017 Aug;19(8):1165-1170. doi: 10.1111/dom.12928. Epub 2017 Apr 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: 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 and ZGN-440 for injectable suspension in people with Obesity and Over-weight, run by Zafgen, Inc. at 4 sites in 2 countries.
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 11 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 4 sites in United States, 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?
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?
On the ClinicalTrials.gov record for NCT02063295, 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 18 Jul 2016.