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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Cabergoline prevent weight regain in people with obesity?
Scientific title
Does Cabergoline prevent weight regain in people with obesity?
Secondary ID [1] 273140 0
Universal Trial Number (UTN)
Trial acronym
Power study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 270894 0
Condition category
Condition code
Metabolic and Endocrine 279069 279069 0 0
Metabolic disorders
Diet and Nutrition 285751 285751 0 0

Study type
Description of intervention(s) / exposure
Cabergoline 0.5mg once weekly taken orally for two years
Intervention code [1] 269481 0
Treatment: Drugs
Intervention code [2] 284020 0
Comparator / control treatment
matching capsule with Placebo powder
Control group

Primary outcome [1] 279719 0
Prevention of weight regain after initial weight loss.
Serum prolactin concentration measurements will be measured as well as compliance.
Timepoint [1] 279719 0
6, 12, 18 and 24 months
Secondary outcome [1] 294290 0
Change in body weight, BMI, waist circumference & blood pressure. BMI - measuring weight and height and calculating waist circumference - measuring at each visit
Timepoint [1] 294290 0
3-12 monthly over 2 years.
Secondary outcome [2] 295492 0
Changes in body composition as measured by DEXA
Timepoint [2] 295492 0
start of study and at 2 year end
Secondary outcome [3] 295493 0
Changes in lipid profile, fasting glucose, insulin sensitivity as measured by HOMA, Leptin, Prolactin
Timepoint [3] 295493 0
6 monthly over 2 years ,
Secondary outcome [4] 295494 0
Weight maintenance according to dopamine receptor allele staus
Timepoint [4] 295494 0
one off blood test at randomisation
Secondary outcome [5] 295495 0
changes in resting energy expenditure, measured with cosmed pulmonary function equipment
Timepoint [5] 295495 0
at screening, randomisation and then 6 monthly for rest of study timeframe
Secondary outcome [6] 295496 0
changes in quality of life measured by questionnaire
Timepoint [6] 295496 0
6 monthly
Secondary outcome [7] 295497 0
Adverse events
e.g. dizziness, headache, nausea
Timepoint [7] 295497 0
recorded at each study visit
Secondary outcome [8] 346322 0
Changes in brain activity via EEG
Timepoint [8] 346322 0
at screening, randomisation and 3 months after starting study medication

Key inclusion criteria
BMI>30 (lean participants for substudy - BMI <25)
Male or female
20-65 years
pre-menopausal women must be using apropriate contraception
Minimum age
20 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
BMI <30 (lean participants for substudy - BMI >25)
Cardiac disease
vascular disease
uncontrolled hypertension
psychiatric disease
other significant medical condition
women with child-bearing potential (not on appropriate contraception)
Participants using medication that could interact with cabergoline

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3878 0
New Zealand
State/province [1] 3878 0

Funding & Sponsors
Funding source category [1] 269957 0
Government body
Name [1] 269957 0
Health Research Council
Address [1] 269957 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 269957 0
New Zealand
Primary sponsor type
Government body
Health Research Council
PO Box 5541, Wellesley Street, Auckland 1141
New Zealand
Secondary sponsor category [1] 283432 0
Name [1] 283432 0
Address [1] 283432 0
Country [1] 283432 0

Ethics approval
Ethics application status
Ethics committee name [1] 271926 0
Lower South regional ethics committee
Ethics committee address [1] 271926 0
Postal address:
PO Box 5849
Dunedin 9016

Courier address:
c/- Ministry of Health
229 Moray Place
Dunedin 9016
Ethics committee country [1] 271926 0
New Zealand
Date submitted for ethics approval [1] 271926 0
Approval date [1] 271926 0
Ethics approval number [1] 271926 0

Brief summary
Obesity is a major public and personal global health issue. A major clinical issue in managing the obese individual is the prevention of weight regain following successful weight loss initiatives. There has been recent interest in the role of the central neurotransmitter dopamine on appetite control and energy balance, and several small studies have suggested that dopamine agonist medication could be a novel way to treat obesity. This randomised controlled trial will identify if the dopamine agonist drug Cabergoline is effective at preventing weight regain. 200 obese people will be included in the trial and followed for 2 years. A subset of these participants will complete additional procedures to measure brain activity changes alongside weight loss and study medication. If Cabergoline is successful at preventing weight regain it could have a major impact on how obesity is managed and could open up an new area of future research for this class of medication
Trial website
Trial related presentations / publications
Public notes
The substudy was added after 195 participants had been recruited for the main study to measure the effects of weight loss and Cabergoline on brain activity with EEG in approximately 35-40 participants in the Cabergoline trial. Matched lean participants under the same inclusion and exclusion criteria with the exception of different BMI criteria were also added as controls for cross-sectional analysis.

Principal investigator
Name 33222 0
A/Prof Patrick Manning
Address 33222 0
Endocrinology Research Unit P.O. Box 913 Dunedin 9054 New Zealand
Country 33222 0
New Zealand
Phone 33222 0
+64 (03) 474 0999
Fax 33222 0
+64 (03) 470 9926
Email 33222 0
Contact person for public queries
Name 16469 0
Ms Anne Ryalls
Address 16469 0
Endocrinology Research Unit
P.O. Box 913
Dunedin 9054
New Zealand
Country 16469 0
New Zealand
Phone 16469 0
64 (03) 474 7733
Fax 16469 0
64 (03) 470 9926
Email 16469 0
Contact person for scientific queries
Name 7397 0
A/Prof Patrick Manning
Address 7397 0
Endocrinology Research Unit
P.O. Box 913
Dunedin 9054
New Zealand
Country 7397 0
New Zealand
Phone 7397 0
64 (03) 474 0999
Fax 7397 0
64 (03) 470 9926
Email 7397 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary