NCT01666691

Brief Summary

The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

August 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

August 8, 2012

Last Update Submit

July 13, 2016

Conditions

Obesity

Keywords

ObeseObesityOverweightWeight lossWeight reductionBeloranib

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks

    Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.

    Up to 26 weeks

  • Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440

    Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.

    Up to 13 weeks

Secondary Outcomes (3)

  • Pharmacodynamics over a dose range of beloranib

    Up to 12 weeks

  • Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously

    Up to 12 weeks

  • Apparent bioavailability over a dose range of beloranib

    Up to 12 weeks

Study Arms (6)

Placebo

PLACEBO COMPARATOR

ZGN-440 sterile diluent

Drug: Placebo

0.3 mg Beloranib

EXPERIMENTAL

0.3 mg ZGN-440 for injectable suspension

Drug: Beloranib

0.6 mg Beloranib

EXPERIMENTAL

0.6 mg ZGN-440 for injectable suspension

Drug: Beloranib

1.2 mg Beloranib

EXPERIMENTAL

1.2 mg ZGN-440 for injectable suspension

Drug: Beloranib

2.4 mg Beloranib

EXPERIMENTAL

2.4 mg ZGN-440 for injectable suspension

Drug: Beloranib

3.2 mg Beloranib

EXPERIMENTAL

3.2 mg ZGN-440 for injectable suspension

Drug: Beloranib

Interventions

BeloranibDRUG

Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.

Also known as: ZGN-440 for injectable suspension, ZGN-440, ZGN-433
0.3 mg Beloranib0.6 mg Beloranib1.2 mg Beloranib2.4 mg Beloranib3.2 mg Beloranib
PlaceboDRUG

Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.

Also known as: ZGN-440 sterile diluent
Placebo

Eligibility Criteria

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

You may qualify if:

  • Obese volunteers weighing ≥ 50 kg
  • BMI ≥ 30 and ≤ 50 kg/m2
  • Stable body weight during the past 2 months
  • Type 2 diabetes mellitus is allowed

You may not qualify if:

  • Use of weight loss agents in the past month
  • Current, clinically significant eating disorder
  • Type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Q-Pharm Clinics, Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Location

CMAX

Adelaide, South Australia, 5000, Australia

Location

Linear Clinical Research Ltd

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Interventions

CKD732

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • J K Marjason, MD

    Q-Pharm Clinics, Royal Brisbane and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

AU(3)