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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02063295

Enrollment

Registered

2014-02-14

Start date

2014-04-30

Completion date

2014-11-30

Last updated

2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniopharyngioma, Hypothalamic Injury, Obesity, Over-weight

Keywords

Beloranib, ZGN-440, ZGN-440 for injectable suspension, ZGN-433

Brief summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.

Interventions

DRUGZGN-440 sterile diluent

ZGN-440 sterile diluent/placebo

DRUGZGN-440 for injectable suspension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in body weight from baseline to the end of the randomized dosing period.	4 weeks

Secondary

Measure	Time frame
Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period	4 weeks
Change in hs-CRP from baseline to the end of the randomized dosing period.	4 weeks
Change in hunger from baseline to the end of the randomized dosing period.	4 weeks
Change in quality of life from baseline to the end of the randomized dosing period.	4 weeks

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026