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Trial registered on ANZCTR


Registration number
ACTRN12625000071426
Ethics application status
Approved
Date submitted
21/11/2024
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Safety and Effectiveness of Tirzepatide: Initial Findings from Greece
Scientific title
Safety and efficacy of tirzepatide in promoting weight loss: Preliminary results in obese Greek adults.
Secondary ID [1] 313438 0
Nill Known
Universal Trial Number (UTN)
U1111-1315-8939
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 335816 0
Condition category
Condition code
Metabolic and Endocrine 332394 332394 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-arm intervantional study.
Patients with obesity , Body Mass Index (BMI) of 30 or more, or 27 or more and at least one weight-related complication, will be treated with tirzepatide , a dual agonist for the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
Administration: Once weekly via subcutaneous injection (SQ- self-administered by patient) with incremental dosage adjustments:The initial dosage of tirzepatide for treatment initiation will be 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. Thereafter, the dose will ne escalated by 2.5 mg after at least 4 weeks on its dose. The maximum tirzepatide dosage will be 15 mg SQ once weekly.The total duration of tirzepatide administration for each participant will be 1 year.
Patients who will be unable to tolerate the dose escalation will continue on the maximum previously tolerated dose for the remainder of the study period.
Adherence to the intervention will be based on self-reporting by the participants.
Intervention code [1] 330004 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339946 0
Weight loss
Timepoint [1] 339946 0
Baseline, 3 months, 6 months, 1 year (primary endpoint) and 6 months after treatment discontinuation
Primary outcome [2] 339947 0
Adverse effects related to the specific used drug ( eg: nausea, gastrointestinal symptoms, hypoglacemia, allergic reactions, pancreatitis,acute cholecystitis,medulary thyroid cancer).
Timepoint [2] 339947 0
Participants will be monitored for potential adverse effects during the treatment period. Blood levels will be obtained at baseline, 3 months, 6 months and 12 months of therapy.
Secondary outcome [1] 442026 0
total cholesterol, high-density cholesterol, low density cholesterol, triglyceridesipids (lipids metabolism) will be assessed as a composite outcome
Timepoint [1] 442026 0
Blood levels will be obtained at baseline, 3 months, 6 months and 12 months of therapy.
Secondary outcome [2] 442027 0
estimation of body composition
Timepoint [2] 442027 0
baseline, 3 months, 6 months and 12 months of therapy.

Eligibility
Key inclusion criteria
Patients with obesity (BMI; the weight in kilograms divided by the square of the height in meters, of 30 or more, or 27 or more and at least one weight-related complication):e.g., hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
Minimum age
35 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A change in body weight of more than 5 kg within 90 days before screening, previous or planned surgical treatment for obesity, and treatment with a medication that promotes weight loss within 90 days before screening.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2025
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26748 0
Greece
State/province [1] 26748 0

Funding & Sponsors
Funding source category [1] 317873 0
Self funded/Unfunded
Name [1] 317873 0
Country [1] 317873 0
Primary sponsor type
Charities/Societies/Foundations
Name
Hellenic Endocrine Network
Address
Country
Greece
Secondary sponsor category [1] 320208 0
None
Name [1] 320208 0
Address [1] 320208 0
Country [1] 320208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316556 0
Hellenic Endocrine Network Ethics Committee
Ethics committee address [1] 316556 0
Ethics committee country [1] 316556 0
Greece
Date submitted for ethics approval [1] 316556 0
19/11/2024
Approval date [1] 316556 0
30/12/2024
Ethics approval number [1] 316556 0

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

Contacts
Principal investigator
Name 138250 0
Dr Nicholaos George Angelopoulos
Address 138250 0
Veniselou 26G, Kavala,65302,"EndoErgo",Endocrine Clinic
Country 138250 0
Greece
Phone 138250 0
+302510225200
Fax 138250 0
Email 138250 0
[email protected]
Contact person for public queries
Name 138251 0
Nicholaos George Angelopoulos
Address 138251 0
Veniselou 26G, Kavala,65302,"EndoErgo",Endocrine Clinic
Country 138251 0
Greece
Phone 138251 0
+302510225200
Fax 138251 0
Email 138251 0
[email protected]
Contact person for scientific queries
Name 138252 0
Nicholaos George Angelopoulos
Address 138252 0
Veniselou 26G, Kavala,65302,"EndoErgo",Endocrine Clinic
Country 138252 0
Greece
Phone 138252 0
+302510225200
Fax 138252 0
Email 138252 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data will be or are expected to be shared?
• Individual participant data not covered above: all of the individual participant data collected during the trial, after de-identification

What types of analyses could be conducted using the individual participant data?
• any purpose

When might the individual participant data become available to request access, and for how long?
From:
Beginning 3 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator (email: [email protected])

Are there additional conditions or steps involved in requesting or accessing individual participant data?
No
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (email: [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24353Clinical study report  [email protected]
24354Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.