ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12617000542392

Ethics application status

Approved

Date submitted

3/04/2017

Date registered

18/04/2017

Date last updated

15/02/2019

Date data sharing statement initially provided

15/02/2019

Date results provided

15/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Blood pressure, heart rate and energy expenditure effects of the drug mirabegron.

Scientific title

Metabolic and cardiovascular responses to a beta-3 adrenergic receptor drug in healthy adults.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1195-0358

Trial acronym

N/A

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Metabolic and Endocrine

Metabolic disorders

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a dose finding study to determine the dose response to increasing amounts of the beta-3 adrenergic receptor agonist mirabegron (outcome measurements listed subsequently).

Participants will be screened and given a medical assessment by a physician. If cleared for participation the physician will approve a prescription for participants to partake in the drug trials described below.

Participation will involve visiting the laboratory on 4 separate occasions, with each visit involving an oral dose of the drug mirabegron in a multiple ascending dose manner, each separated by between 3-14 days (based on participant availability). The 4 doses will be 50, 100, 150 and 200 mg.

Measurements of blood pressure, heart rate and energy expenditure (via indirect calorimetry) will be collected before and at 30 minute intervals after drug ingestion for 3 hours.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Dose comparison (between all 4 different doses).

Control group

Dose comparison

Outcomes

Primary outcome [1]

Energy expenditure via indirect calorimetry

Timepoint [1]

Energy expenditure will be assessed by measurement for 10 minutes before administering the drug dose, then for 10 minutes, every 30 minutes (eg, from 20-30 min, 50-60 min, 80-90 min, and so on) until 3 hours (from 170-180 minutes) post dosing. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.

Secondary outcome [1]

heart rate via an automated sphygmomanometer

Timepoint [1]

Heart rate will be assessed by measurement before administering the drug dose, then every 30 minutes post dosing for 3 hours. Each individual measurement will take approximately 30 seconds. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.

Secondary outcome [2]

Blood pressure via an automated sphygmomanometer

Timepoint [2]

Blood pressure will be assessed by measurement before administering the drug dose, then every 30 minutes post dosing for 3 hours. Each individual measurement will take approximately 30 seconds. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.

Eligibility

Key inclusion criteria

- Aged 18 – 40 years
- Not currently taking any prescription medications or other supplements or medications known to alter cardiovascular parameters or increase energy expenditure (as assessed by the study physician during medical screening)
- No history of major illness (as assessed by the study physician during medical screening)
- BMI equal to or less than 30 kg/m^2

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Hypertension (resting supine blood pressure greater than 140/90 mmHg)
- Pregnancy

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

N/A

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

N/A

Phase

Type of endpoint/s

Pharmacodynamics

Statistical methods / analysis

Repeated measures ANOVA will be used to determine whether differences exist between treatment doses for the key outcomes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

3/04/2017

Date of last participant enrolment

Anticipated

19/11/2018

Actual

31/07/2017

Date of last data collection

Anticipated

17/12/2018

Actual

27/10/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Baker Heart and Diabetes Institute - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Baker Heart and Diabetes Institute

Address [1]

PO Box 6492
Melbourne, Vic
3004

Country [1]

Australia

Primary sponsor type

Other

Name

Baker Heart and Diabetes Institute

Address

PO Box 6492
Melbourne, Vic
3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Ethics Committee

Ethics committee address [1]

Old Baker Building, Level 1,
55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2017

Approval date [1]

31/03/2017

Ethics approval number [1]

047/17

Summary

Brief summary

Increasing energy expenditure to reverse obesity may be possible using beta-3 adrenergic receptor agonist drugs, however it was not until recently that such drugs have been available under prescription. These approved drugs were developed for purposes other than treatment of obesity, so they have never been studied in this context.

In this proposal, we will conduct a pilot study to determine the effects of multiple doses (the highest prescription dose of 50 mg, plus 100, 150 and 200mg) of the beta-3 adrenergic receptor agonist, mirabegron, on whole body energy expenditure and cardiovascular responses. This will be a dose finding study for which the purpose is to obtain data in order to inform a larger trial which will be conducted subsequently. We aim to determine the highest dose which will maximise energy expenditure without effects on the cardiovascular system.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew Carey

Address

Baker Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic
3004

Country

Australia

Phone

61 3 8532 1251

Fax

andrew.carey@baker.edu.au

Contact person for public queries

Name

Andrew Carey

Address

Baker Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic
3004

Country

Australia

Phone

61 3 8532 1251

Fax

andrew.carey@baker.edu.au

Contact person for scientific queries

Name

Andrew Carey

Address

Baker Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic
3004

Country

Australia

Phone

61 3 8532 1251

Fax

andrew.carey@baker.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Acute metabolic and cardiovascular effects of mirabegron in healthy individuals.	2019	https://dx.doi.org/10.1111/dom.13516

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically