NCT00954057

Brief Summary

This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Geographic Reach
2 countries

5 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

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

August 4, 2009

Last Update Submit

March 5, 2015

Conditions

Thyroid-Related Eye Disease

Keywords

TED

Outcome Measures

Primary Outcomes (1)

  • Safety: physical examinations, laboratory tests, VISA activity score, AE assessments

    8 weeks treatment and 1 week follow up

Secondary Outcomes (1)

  • Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction

    8 weeks treatment and 1 week follow up

Study Arms (2)

LIPO-102

EXPERIMENTAL

Intraorbital Injection

Drug: LIPO-102

Placebo

PLACEBO COMPARATOR

Intraorbital Injection

Drug: Placebo

Interventions

LIPO-102DRUG

intraorbital injection

LIPO-102
PlaceboDRUG

intraorbital injection

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or Non pregnant female
  • Symptomatic exophthalmos
  • Inactive Thyroid Eye Disease
  • Signed informed consent

You may not qualify if:

  • Known hypersensitivity to study drugs
  • Treatment with an investigational agent within 30 days of first dose
  • History of Thyroid Eye Disease less than 6 months
  • Previous decompression surgery
  • Glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Adelaide, Australia

Location

Unknown Facility

Brisbane, Australia

Location

Unknown Facility

Melbourne, Australia

Location

Unknown Facility

Sydney, Australia

Location

Unknown Facility

Auckland, New Zealand

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

NZ(1)AU(4)