An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01818921

Enrollment

Registered

2013-03-27

Start date

2013-06-30

Completion date

2013-11-30

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

Obesity, Over-weight, Prader-Willi Syndrome

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 for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.

Interventions

DRUGZGN-440 sterile diluent

ZGN-440 sterile diluent/placebo

DRUG1.2 mg ZGN-440 for injectable suspension

1.2 mg beloranib

DRUG1.8 mg ZGN-440 for injectable suspension

1.8 mg beloranib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Use of weight loss agents in the past 3 months * Type 1 diabetes mellitus * Current or anticipated chronic use of narcotics or opiates

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

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