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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06717698




Registration number
NCT06717698
Ethics application status
Date submitted
30/11/2024
Date registered
5/12/2024

Titles & IDs
Public title
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
Scientific title
Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study
Secondary ID [1] 0 0
U1111-1302-5591
Secondary ID [2] 0 0
NN9541-7841
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNC0519-0130
Treatment: Drugs - Placebo
Treatment: Drugs - Semaglutide

Experimental: Dosing scheme a: NNC0519-0130 - Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Placebo comparator: Dosing scheme a: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Experimental: Dosing scheme b: NNC0519-0130 - Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Placebo comparator: Dosing scheme b: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Experimental: Dosing scheme c: NNC0519-0130 - Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Placebo comparator: Dosing scheme c: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Experimental: Dosing scheme d: NNC0519-0130 - Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Placebo comparator: Dosing scheme d: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Active comparator: Dosing scheme e: Semaglutide - Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.


Treatment: Drugs: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.

Treatment: Drugs: Placebo
Placebo matching NNC0519-0130 will be administered subcutaneously.

Treatment: Drugs: Semaglutide
Semaglutide will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in urinary albumin-to-creatinine ratio (UACR) at week 12
Timepoint [1] 0 0
From baseline (week 0) to end of a given maintenance dose period (week 12)
Primary outcome [2] 0 0
Change in urinary albumin-to-creatinine ratio (UACR) at week 24
Timepoint [2] 0 0
From baseline (week 0) to end of a given maintenance dose period (week 24)
Primary outcome [3] 0 0
Change in urinary albumin-to-creatinine ratio (UACR) at week 36
Timepoint [3] 0 0
From baseline (week 0) to end of a given maintenance dose period (week 36)
Secondary outcome [1] 0 0
Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [2] 0 0
Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [3] 0 0
Relative change in body weight
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [4] 0 0
Achievement of greater than or equal to (=) 5 percentage (%) weight reduction
Timepoint [4] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [5] 0 0
Achievement of greater than or equal to (=) 10 percentage (%) weight reduction
Timepoint [5] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [6] 0 0
Change in waist circumference
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [7] 0 0
Change in glycated haemoglobin (HbA1c)
Timepoint [7] 0 0
From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)
Secondary outcome [8] 0 0
Change in systolic blood pressure
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [9] 0 0
Change in diastolic blood pressure
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [10] 0 0
Number of treatment emergent adverse events (TEAEs)
Timepoint [10] 0 0
From baseline (week 0) to end of study (week 40)

Eligibility
Key inclusion criteria
* Female of non-childbearing potential, or male.

* For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (=) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.

* HbA1c of 6.5 percentage (%)-10.5 percentage (%) [48 - 91 millimoles per mole (mmol/mol)] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (<)6.5 percentage (%) [<48 mmol/mol] if not diagnosed with type 2 diabetes mellitus.
* BMI greater than or equal to (=) 27.0 kilogram per square metre (kg/m^2) at screening.
* Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (=) 15 and less than (<) 90 mL/min/1.73 m^2.
* Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (=)100 and less than (<) 5000 milligram per gram (mg/g).
* Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency.
* Lupus nephritis or antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
* Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to screening.
* Use of any glucagon-like peptide-1 (GLP-1) RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.
* Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.
* Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
* Only applicable for participants with type 2 diabetes (T2D): Uncontrolled and potentially unstable diabetic retinopathy or diabetic maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before 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)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/09/2026
Actual
Sample size
Target
465
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Castle Hill Medical Centre - Castle Hill
Recruitment hospital [2] 0 0
Gosford Renal Research - Gosford
Recruitment hospital [3] 0 0
Heart of Australia - Chelmer
Recruitment hospital [4] 0 0
Melbourne Renal Research Group - Reservoir
Recruitment hospital [5] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2154 - Castle Hill
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
4068 - Chelmer
Recruitment postcode(s) [4] 0 0
3073 - Reservoir
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
City of Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Corrientes
Country [15] 0 0
Argentina
State/province [15] 0 0
Mar Del Plata, Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Mar del Plata
Country [17] 0 0
Brazil
State/province [17] 0 0
Parana
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Bankya
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Sofia
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Varna
Country [23] 0 0
Czechia
State/province [23] 0 0
Frýdek Místek
Country [24] 0 0
Czechia
State/province [24] 0 0
Hodonin
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 10
Country [26] 0 0
Czechia
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Praha 4
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Czechia
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Praha 6
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Czechia
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Praha
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Czechia
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Smirice
Country [30] 0 0
Czechia
State/province [30] 0 0
Ceský Krumlov
Country [31] 0 0
India
State/province [31] 0 0
Andhra Pradesh
Country [32] 0 0
India
State/province [32] 0 0
Karnataka
Country [33] 0 0
India
State/province [33] 0 0
Kerala
Country [34] 0 0
India
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Rajasthan
Country [35] 0 0
India
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Telangana
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Italy
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Abbruzzo
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Italy
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Abruzzo
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Italy
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BO
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Milano
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Italy
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Pisa
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Italy
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Roma
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Japan
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Aichi
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Kita-ku, Tokyo
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Japan
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Saitama
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Japan
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Sendai-shi, Miyagi
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Japan
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Siga
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Japan
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Tokyo
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Korea, Republic of
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Busan
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Goyang
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Malaysia
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Miri
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Malaysia
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Perak
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Malaysia
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Sarawak
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Malaysia
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Wilayah Persekutuan Kuala Lumpur
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Malaysia
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Kota Bharu, Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Melaka
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Pulau Pinang
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Malaysia
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Sungai Buloh
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Kujawsko-pomorskie
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Lubelskie Voivodeship
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Podkarpackie
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Bialystok
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Katowice
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Lublin
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Olsztyn
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Szczecin
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Tczew
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Warszawa
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Wroclaw
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Lódz
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Poland
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Swiecie
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona
Country [80] 0 0
Spain
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Córdoba
Country [81] 0 0
Spain
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Getafe
Country [82] 0 0
Spain
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Hospitalet de Llobregat
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
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Sevilla
Country [85] 0 0
Spain
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Valencia
Country [86] 0 0
Turkey
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Melikgazi
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
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Izmir
Country [92] 0 0
Turkey
State/province [92] 0 0
Kocaeli

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06717698