Clinical trial · Interventional
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
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
NCT02063295CI-TRIAL-00023108completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniopharyngioma | Craniopharyngioma | ONTOLOGY_EXACT | 0.90 |
| Hypothalamic Injury | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Over-weight | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZGN-440 for injectable suspension | Drug | — | UNRESOLVED |
| ZGN-440 sterile diluent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- ZGN-440 sterile diluent
- description
- Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
- interventionNames
- Drug: ZGN-440 sterile diluent
- type
- EXPERIMENTAL
- label
- ZGN-440 for injectable suspension
- description
- Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
- interventionNames
- Drug: ZGN-440 for injectable suspension
Primary outcomes (1)
- measure
- Change in body weight from baseline to the end of the randomized dosing period.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDShoemaker 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. PMID 28261955