Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000067673
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
2/08/2005
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of AOD9604 on weight loss in obese adults.
Scientific title
A Phase IIb, Randomised, Double-Blind, Placebo-Controlled Study To Assess The Efficacy, Safety And Tolerability Of 24 Weeks Treatment With Different Doses Of AOD9604 Tablets On Weight Loss In Obese Adults.
Secondary ID [1] 94 0
Metabolic Pharmaceuticals Ltd: METAOD006
Universal Trial Number (UTN)
Trial acronym
The "Options" Study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity. 139 0
Condition category
Condition code
Diet and Nutrition 159 159 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment regimen consists of 6 months (24 weeks) of orally administered AOD9604 tablets (0.25 mg, 0.5 mg or 1 mg) once per day.
Intervention code [1] 90 0
Treatment: Drugs
Comparator / control treatment
Placebo once per day.
Control group
Placebo

Outcomes
Primary outcome [1] 197 0
To determine if orally administered AOD9604 causes a reduction in body weight following daily dosing for 12 weeks.
Timepoint [1] 197 0
At screening, baseline and 2, 4, 6, 8 and 12 weeks following treatment. commencement.
Primary outcome [2] 198 0
To investigate the safety and tolerability profile of AOD9604 following daily dosing for 24 weeks.
Timepoint [2] 198 0
At screening, baseline, and 2, 4, 6, 8, 12, 16, 20, and 24 weeks following treatment commencement, and 4 weeks following treatment cessation.
Secondary outcome [1] 451 0
To determine if orally administered AOD9604 causes a reduction in body weight following daily dosing for 24 weeks.
Timepoint [1] 451 0
At screening, baseline and 2, 4, 6, 8, 12, 16, 20 and 24 weeks following treatment. commencement.
Secondary outcome [2] 452 0
To determine if orally administered AOD9604 causes a reduction in waist circumference following daily dosing for 24 weeks.
Timepoint [2] 452 0
At screening, baseline, and 2, 4, 6, 8, 12, 16, 20, and 24 weeks following treatment commencement.
Secondary outcome [3] 453 0
To determine the effect of AOD9604 on body composition as assessed by Dual Energy X-ray Absorptiometry (DEXA) following daily dosing for 24 weeks.
Timepoint [3] 453 0
At baseline and 12 and 24 weeks following treatment commencement.
Secondary outcome [4] 454 0
To determine if orally administered AOD9604 causes an improvement in glucose tolerance following daily dosing for 24 weeks.
Timepoint [4] 454 0
At baseline and 12 and 24 weeks following treatment commencement.
Secondary outcome [5] 455 0
To determine if orally administered AOD9604 causes an improvement in lipid profiles following once daily dosing for 24 weeks.
Timepoint [5] 455 0
At screening, baseline and 12 and 24 weeks following treatment commencement.

Eligibility
Key inclusion criteria
BMI of >= 30 kg/m2 and = < 45 kg/m2 with a waist circumference of > = 102 cm (males) or >= 95 cm (females) who are otherwise healthy.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects taking regular medication, diabetes, hypertension, hypersensitivity to hGH-related products, severe or multiple allergies, dieting or participation in any weight reduction programme in the 3 months prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will involve an interactive voice response system (IVRS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A central randomisation sytem will be used. At the baseline and randomisation visit (Visit 3) participants will be stratified by the IVRS according to a number of initial variables.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 397 0
2050
Recruitment postcode(s) [2] 353 0
2145
Recruitment postcode(s) [3] 395 0
2522
Recruitment postcode(s) [4] 399 0
2601
Recruitment postcode(s) [5] 402 0
3128
Recruitment postcode(s) [6] 405 0
3144
Recruitment postcode(s) [7] 401 0
4068
Recruitment postcode(s) [8] 400 0
4102
Recruitment postcode(s) [9] 396 0
5000
Recruitment postcode(s) [10] 403 0
5011
Recruitment postcode(s) [11] 404 0
5035
Recruitment postcode(s) [12] 398 0
6009

Funding & Sponsors
Funding source category [1] 212 0
Commercial sector/Industry
Name [1] 212 0
Metabolic Pharmaceuticals Ltd
Country [1] 212 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metabolic Pharmaceuticals Ltd
Address
Level 3, 509 St Kilda Rd
Melbourne 3004
Country
Australia
Secondary sponsor category [1] 159 0
None
Name [1] 159 0
N/A
Address [1] 159 0
Country [1] 159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 975 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 975 0
Ethics committee country [1] 975 0
Australia
Date submitted for ethics approval [1] 975 0
05/08/2005
Approval date [1] 975 0
24/08/2005
Ethics approval number [1] 975 0
09-22-08-05
Ethics committee name [2] 976 0
Research Ethics Committee, Royal Adelaide Hospital
Ethics committee address [2] 976 0
Ethics committee country [2] 976 0
Australia
Date submitted for ethics approval [2] 976 0
16/08/2005
Approval date [2] 976 0
28/09/2005
Ethics approval number [2] 976 0
050915
Ethics committee name [3] 977 0
Belberry Human Research Ethics Committee
Ethics committee address [3] 977 0
Ethics committee country [3] 977 0
Australia
Date submitted for ethics approval [3] 977 0
19/08/2005
Approval date [3] 977 0
06/10/2005
Ethics approval number [3] 977 0
Protocol METAOD006
Ethics committee name [4] 4462 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [4] 4462 0
Ethics committee country [4] 4462 0
Australia
Date submitted for ethics approval [4] 4462 0
12/09/2005
Approval date [4] 4462 0
29/11/2005
Ethics approval number [4] 4462 0
2005/11/4.27(2211)
Ethics committee name [5] 4463 0
Joint Human Research Ethics Committee of the University of Wollongong and Illawarra Area Health Service
Ethics committee address [5] 4463 0
Ethics committee country [5] 4463 0
Australia
Date submitted for ethics approval [5] 4463 0
22/08/2005
Approval date [5] 4463 0
27/10/2005
Ethics approval number [5] 4463 0
CT05/029
Ethics committee name [6] 4464 0
Ethics Review Committee (Royal Prince Alfred Hospital Zone)
Ethics committee address [6] 4464 0
Ethics committee country [6] 4464 0
Australia
Date submitted for ethics approval [6] 4464 0
08/10/2005
Approval date [6] 4464 0
27/10/2005
Ethics approval number [6] 4464 0
X05-0268
Ethics committee name [7] 4465 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [7] 4465 0
Ethics committee country [7] 4465 0
Australia
Date submitted for ethics approval [7] 4465 0
25/09/2005
Approval date [7] 4465 0
22/11/2005
Ethics approval number [7] 4465 0
2005-120
Ethics committee name [8] 4466 0
Royal Perth Hospital Ethics Committee
Ethics committee address [8] 4466 0
Ethics committee country [8] 4466 0
Australia
Date submitted for ethics approval [8] 4466 0
02/10/2005
Approval date [8] 4466 0
25/10/2005
Ethics approval number [8] 4466 0
EC 2006/038
Ethics committee name [9] 4467 0
ACT Health and Community Care Human Research Ethics Committee
Ethics committee address [9] 4467 0
Ethics committee country [9] 4467 0
Australia
Date submitted for ethics approval [9] 4467 0
26/09/2005
Approval date [9] 4467 0
29/11/2005
Ethics approval number [9] 4467 0
ETH 9/05.695
Ethics committee name [10] 4468 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [10] 4468 0
Ethics committee country [10] 4468 0
Australia
Date submitted for ethics approval [10] 4468 0
18/09/2005
Approval date [10] 4468 0
16/01/2006
Ethics approval number [10] 4468 0
2005/161
Ethics committee name [11] 4469 0
The Uniting Healthcare Human Research Ethics Committee
Ethics committee address [11] 4469 0
Ethics committee country [11] 4469 0
Australia
Date submitted for ethics approval [11] 4469 0
29/09/2005
Approval date [11] 4469 0
08/11/2005
Ethics approval number [11] 4469 0
2005/44
Ethics committee name [12] 4470 0
Eastern Health Research and Ethics Committee
Ethics committee address [12] 4470 0
Ethics committee country [12] 4470 0
Australia
Date submitted for ethics approval [12] 4470 0
22/08/2005
Approval date [12] 4470 0
07/11/2005
Ethics approval number [12] 4470 0
E17/0506
Ethics committee name [13] 4471 0
Central Northern Adelaide Health Service Ethics of Human Research Committee
Ethics committee address [13] 4471 0
Ethics committee country [13] 4471 0
Australia
Date submitted for ethics approval [13] 4471 0
02/09/2005
Approval date [13] 4471 0
24/11/2005
Ethics approval number [13] 4471 0
2005114

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36003 0
Address 36003 0
Country 36003 0
Phone 36003 0
Fax 36003 0
Email 36003 0
Contact person for public queries
Name 9279 0
Dr Caroline Herd
Address 9279 0
Metabolic Pharmaceuticals Ltd
Level 3
509 St Kilda Rd
Melbourne VIC 3004
Country 9279 0
Australia
Phone 9279 0
+61 3 98605700
Fax 9279 0
+61 3 98605777
Email 9279 0
[email protected]
Contact person for scientific queries
Name 207 0
Dr Caroline Herd
Address 207 0
Metabolic Pharmaceuticals Ltd
Level 3
509 St Kilda Rd
Melbourne VIC 3004
Country 207 0
Australia
Phone 207 0
+61 3 98605700
Fax 207 0
+61 3 98605777
Email 207 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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