NCT02063295

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2 obesity

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

February 12, 2014

Last Update Submit

July 14, 2016

Conditions

ObesityOver-weightHypothalamic InjuryCraniopharyngioma

Keywords

BeloranibZGN-440ZGN-440 for injectable suspensionZGN-433

Outcome Measures

Primary Outcomes (1)

  • Change in body weight from baseline to the end of the randomized dosing period.

    4 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

ZGN-440 sterile diluent

PLACEBO COMPARATOR

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

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.

Drug: ZGN-440 for injectable suspension

Interventions

ZGN-440 sterile diluentDRUG

ZGN-440 sterile diluent/placebo

Also known as: Placebo
ZGN-440 sterile diluent
ZGN-440 for injectable suspensionDRUG
Also known as: ZGN-440, Beloranib
ZGN-440 for injectable suspension

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The Boden Institute

Sydney, New South Wales, 2006, Australia

Location

Austin Health, Metabolic Disorders Centre

Heidelberg Heights, Victoria, 3081, Australia

Location

Related Publications (1)

  • 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.

    PMID: 28261955DERIVED

MeSH Terms

Conditions

ObesityCraniopharyngioma

Interventions

CKD732

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

AU(2)US(2)