An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

NCT ID: NCT02063295

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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Conditions

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Obesity Over-weight Hypothalamic Injury Craniopharyngioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ZGN-440 sterile diluent

Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.

Group Type PLACEBO_COMPARATOR

ZGN-440 sterile diluent

Intervention Type DRUG

ZGN-440 sterile diluent/placebo

ZGN-440 for injectable suspension

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Group Type EXPERIMENTAL

ZGN-440 for injectable suspension

Intervention Type DRUG

Interventions

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ZGN-440 sterile diluent

ZGN-440 sterile diluent/placebo

Intervention Type DRUG

ZGN-440 for injectable suspension

Intervention Type DRUG

Other Intervention Names

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Placebo ZGN-440 Beloranib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zafgen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

The Boden Institute

Sydney, New South Wales, Australia

Site Status

Austin Health, Metabolic Disorders Centre

Heidelberg Heights, Victoria, Australia

Site Status

Countries

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United States Australia

References

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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.

Reference Type DERIVED
PMID: 28261955 (View on PubMed)

Other Identifiers

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ZAF-221

Identifier Type: -

Identifier Source: org_study_id

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