Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000241437
Ethics application status
Approved
Date submitted
30/01/2025
Date registered
3/04/2025
Date last updated
13/04/2025
Date data sharing statement initially provided
3/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2a double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of GL0034 in adults with at-risk metabolic dysfunction-associated steatohepatitis (MASH)
Scientific title
A Phase 2a double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of GL0034 in adults with at-risk metabolic dysfunction-associated steatohepatitis (MASH)
Secondary ID [1] 313808 0
None
Universal Trial Number (UTN)
None
Trial acronym
SF-CSP-002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic dysfunction-associated steatohepatitis (MASH) 336444 0
Condition category
Condition code
Metabolic and Endocrine 332964 332964 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of participants with at-risk metabolic dysfunction-associated steatohepatitis (MASH).

Approximately 60 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 2:1. GL0034/Placebo is administered weekly as a subcutaneous injection given by a registered nurse for a period of 24 weeks, The dose will be increased gradually for a period of 4 weeks (called the Dose Titration Period). Participants will then receive a final fixed dose (called the Final Dose Period).

Vital signs including temperature, blood pressure and weight will be regularly reviewed in addition to the collection of blood tests every 2-4 weeks to assess overall health and any study drug effects. Blood samples will be collected prior to dosing at week 1 and weekly from weeks 13-27. Blood samples will also be collected 24hrs after dosing at week 13 and 17 and at the following timepoints after the final dose of the study at week 24: Post-dose 1 day, 2 days, 4 days, 7 days, 14 days, 21 days and 28 days The purpose of these blood samples is to measure the levels of GL0034 in the blood.
Intervention code [1] 330396 0
Treatment: Drugs
Comparator / control treatment
Placebo subcutaneous injection. The placebo contains inactive commonly used excipients Disodium Phosphate Dihydrate, Propylene Glycol, Phenol, Hydrochloric Acid and Sodium Hydroxide.
Control group
Placebo

Outcomes
Primary outcome [1] 340504 0
Liver fat content
Timepoint [1] 340504 0
Baseline and at week 24 (following 23 weeks of treatment)
Primary outcome [2] 340505 0
Liver stiffness
Timepoint [2] 340505 0
Baseline and at week 24 (following 23 weeks of treatment)
Secondary outcome [1] 444287 0
Percentage change in liver stiffness
Timepoint [1] 444287 0
Baseline and at Week 16 (following 15 weeks of treatment)
Secondary outcome [2] 444289 0
Percentage change in liver fat content
Timepoint [2] 444289 0
Baseline and at week 16 (following 15 weeks of treatment)
Secondary outcome [3] 444290 0
Proportion of participants with a decrease in liver fat content
Timepoint [3] 444290 0
Baseline and at Week 16 (following 15 weeks of treatment) and Week 24 (following 23 weeks of treatment)
Secondary outcome [4] 444291 0
Proportion of participants with a decrease in liver stiffness
Timepoint [4] 444291 0
Baseline and at Week 16 (following 15 weeks of treatment) and at Week 24 (following 23 weeks of treatment)
Secondary outcome [5] 444292 0
Change in Liver Stiffness Measurement (LSM) and Controlled Attenuation Parameter (CAP)
Timepoint [5] 444292 0
Baseline and at Week 16 (following 15 weeks of treatment) and Week 24 (following 23 weeks of treatment)
Secondary outcome [6] 444293 0
Change in FibroScan-AST score (FAST)
Timepoint [6] 444293 0
Baseline and at Week 16 (following 15 weeks of treatment) and at Week 24 (following 23 weeks of treatment)
Secondary outcome [7] 444294 0
Change in liver function markers
Timepoint [7] 444294 0
Baseline and at Week 5, 9, 13, 14, 16, 17, 18, 20, 21, 24 and 28 post-first treatment dose
Secondary outcome [8] 444295 0
Determine the weight related changes. Composite Body Mass Index (BMI), Waist circumference and weight (Kg)
Timepoint [8] 444295 0
Baseline and at week 4, 8, 12, 16, 20, 24, 25 and 28 post-first treatment dose
Secondary outcome [9] 444296 0
composite measure in changing metabolic, lipid, fibrotic and inflammatory markers
Timepoint [9] 444296 0
Baseline and at weeks 4, 8, 12, 16, 20 and 24 post first-treatment dose
Secondary outcome [10] 444297 0
Previous clinical studies shown TEAE observed to date (IB V3, 18DEC 2024) are the GLP-1 RA class effect such nauseam vomiting, early satiety and decreased appetite. No safety signal or alert were identified in previous clinical studies. Hence, continuing monitoring safety incidence, severity and change from baseline of treatment-emergent AE's in comparison to other GLP-1 RA class medication.
Timepoint [10] 444297 0
Baseline to Week 28 post-first treatment dose
Secondary outcome [11] 445319 0
Change in GL0034 plasma concentration
Timepoint [11] 445319 0
Baseline and at weeks 1, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 post first-treatment dose

Eligibility
Key inclusion criteria
1) Males or females aged 18 to 75
2) Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures
3) BMI greater than or equal to 30.0 kg/m2 and less than or equal to 50 kg/m2
4) MRE liver Stiffness greater than or equal to 3.5 kPa and less than 5.0 kPa
5) MRI-PDFF liver fat content greater than or equal to 8.5%.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Type 1 diabetes mellitus (T1DM) or uncontrolled T2DM
2) Previous anaphylaxis or severe allergic reaction to GLP 1 receptor agonists
3) Treatment with GLP-1 receptor agonists in the period from 90 days prior to screening
4) Underlying conditions that impact participant safety or their ability to follow the protocol.

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)
central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2025
Actual
Date of last participant enrolment
Anticipated
3/08/2026
Actual
Date of last data collection
Anticipated
7/09/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318274 0
Commercial sector/Industry
Name [1] 318274 0
Sun Pharmaceuticals Ltd
Country [1] 318274 0
India
Primary sponsor type
Commercial sector/Industry
Name
Sun Pharmaceuticals Ltd
Address
Country
India
Secondary sponsor category [1] 320661 0
Commercial sector/Industry
Name [1] 320661 0
Local Sponsor: CRO Services Pty Ltd (Trading as Resonance Clinical)
Address [1] 320661 0
Country [1] 320661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316914 0
Bellberry Human Research Ethics Committee L
Ethics committee address [1] 316914 0
Ethics committee country [1] 316914 0
Australia
Date submitted for ethics approval [1] 316914 0
22/01/2025
Approval date [1] 316914 0
14/03/2025
Ethics approval number [1] 316914 0

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

Contacts
Principal investigator
Name 139418 0
Prof John Olynyk
Address 139418 0
Trialswest Pty Ltd, 6 Barrington Street, Spearwood WA 6163
Country 139418 0
Australia
Phone 139418 0
+61 08 9312 1931
Fax 139418 0
Email 139418 0
[email protected]
Contact person for public queries
Name 139419 0
Naomi Brook
Address 139419 0
Resonance Health, 141 Burswood Road, Burswood Western Australia 6100
Country 139419 0
Australia
Phone 139419 0
+61 08 9286 5300
Fax 139419 0
Email 139419 0
[email protected]
Contact person for scientific queries
Name 139420 0
Naomi Brook
Address 139420 0
Resonance Health, 141 Burswood Road, Burswood Western Australia 6100
Country 139420 0
Australia
Phone 139420 0
+61 08 9286 5300
Fax 139420 0
Email 139420 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Intellectual Property



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
No additional documents have been identified.