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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05556512




Registration number
NCT05556512
Ethics application status
Date submitted
22/09/2022
Date registered
27/09/2022

Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity
Secondary ID [1] 0 0
I8F-MC-GPIJ
Secondary ID [2] 0 0
17253
Universal Trial Number (UTN)
Trial acronym
SURMOUNT-MMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

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

Experimental: Tirzepatide - Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.

Placebo comparator: Placebo - Participants will receive tirzepatide matched placebo.


Treatment: Drugs: Tirzepatide
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [1] 0 0
Time to Onset of Type 2 Diabetes (T2D)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [2] 0 0
Estimated Glomerular Filtration Rate (eGFR) Slope
Timepoint [2] 0 0
Up to 5 Years
Secondary outcome [3] 0 0
Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)
Timepoint [3] 0 0
Up to 5 Years
Secondary outcome [4] 0 0
Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score
Timepoint [4] 0 0
Baseline, 2 Years
Secondary outcome [5] 0 0
Time to the Occurrence of All-cause Death
Timepoint [5] 0 0
Up to 5 Years
Secondary outcome [6] 0 0
Time to First Occurrence of CV Death
Timepoint [6] 0 0
Up to 5 Years
Secondary outcome [7] 0 0
Time to First Occurrence of MI
Timepoint [7] 0 0
Up to 5 Years
Secondary outcome [8] 0 0
Time to First Occurrence of Stroke
Timepoint [8] 0 0
Up to 5 Years
Secondary outcome [9] 0 0
Time to First Occurrence of Coronary Revascularization
Timepoint [9] 0 0
Up to 5 Years
Secondary outcome [10] 0 0
Time to First Occurrence Heart Failure (HF) Events
Timepoint [10] 0 0
Up to 5 Years
Secondary outcome [11] 0 0
Time to First Occurrence of Hospitalization for Unstable Angina
Timepoint [11] 0 0
Up to 5 Years
Secondary outcome [12] 0 0
Time to first occurrence of Hospitalization or Urgent Visit
Timepoint [12] 0 0
Up to 5 Years
Secondary outcome [13] 0 0
Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)
Timepoint [13] 0 0
Up to 5 Years
Secondary outcome [14] 0 0
Percent Change from Baseline in Body Weight
Timepoint [14] 0 0
Baseline, 156 Weeks
Secondary outcome [15] 0 0
Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
Timepoint [15] 0 0
Baseline, 156 Weeks
Secondary outcome [16] 0 0
Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)
Timepoint [16] 0 0
Baseline, 156 Weeks
Secondary outcome [17] 0 0
Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%)
Timepoint [17] 0 0
Up to 5 Years

Eligibility
Key inclusion criteria
* Have a body mass index (BMI) =27.0 kilogram/square meter (kg/m ²)
* Are either

* individuals =40 years of age with established cardiovascular disease (CVD).

* CVD is defined as meeting at least one of the following:

* Coronary artery disease
* Cerebrovascular disease
* Peripheral arterial disease OR
* individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention)
* women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or

* women =70 years of age or men, =65 years of age with at least 2 risk factors at screening.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
* Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c =6.5% (=48 millimole/mole (mmol/mol) or fasting glucose (FG) =126 milligram/deciliter (=7.0 millimole/liter (mmol/L).
* Any one of the following CV conditions within 90 days prior to screening

* MI
* acute coronary syndrome
* stroke
* coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or
* acute decompensated heart failure
* Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
* Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening
* Have a presence or history of malignant neoplasms within the past 5 years prior to 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/10/2027
Actual
Sample size
Target
Accrual to date
Final
15374
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [5] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Core Research Group - Brisbane
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Logan Hospital - Meadowbrook
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Nightingale Research - Adelaide
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Royal Adelaide Hospital - Adelaide
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Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
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The Queen Elizabeth Hospital - Woodville
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Royal Hobart Hospital - Hobart
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Box Hill Hospital - Box Hill
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Emeritus Research - Camberwell
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Victorian Heart Hospital - Clayton
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Barwon Health - Geelong
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Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [19] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne - Melbourne
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Advara HeartCare Joondalup - Joondalup
Recruitment hospital [21] 0 0
GenesisCare - Murdoch - Murdoch Drive - Murdoch
Recruitment postcode(s) [1] 0 0
2617 - Bruce
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2148 - Blacktown
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2259 - Kanwal
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2291 - Merewether
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2006 - Sydney
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4029 - Brisbane
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4064 - Brisbane
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4131 - Meadowbrook
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5000 - Adelaide
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5046 - Oaklands Park
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5011 - Woodville
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7000 - Hobart
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3128 - Box Hill
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3124 - Camberwell
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3168 - Clayton
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3220 - Geelong
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3081 - Heidelberg West
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3004 - Melbourne
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6027 - Joondalup
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6150 - Murdoch
Recruitment outside Australia
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Palermo
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Italy
State/province [179] 0 0
Torino
Country [180] 0 0
Japan
State/province [180] 0 0
Fukuoka
Country [181] 0 0
Japan
State/province [181] 0 0
Kyoto
Country [182] 0 0
Japan
State/province [182] 0 0
Osaka
Country [183] 0 0
Japan
State/province [183] 0 0
Tokyo
Country [184] 0 0
Korea, Republic of
State/province [184] 0 0
Kang-won-d
Country [185] 0 0
Korea, Republic of
State/province [185] 0 0
Kyonggi-do
Country [186] 0 0
Korea, Republic of
State/province [186] 0 0
Pusan-Kwangyokshi
Country [187] 0 0
Korea, Republic of
State/province [187] 0 0
Seoul-teukbyeolsi [Seoul]
Country [188] 0 0
Korea, Republic of
State/province [188] 0 0
Seoul-teuk
Country [189] 0 0
Mexico
State/province [189] 0 0
Baja California
Country [190] 0 0
Mexico
State/province [190] 0 0
Distrito Federal
Country [191] 0 0
Mexico
State/province [191] 0 0
Jalisco
Country [192] 0 0
Mexico
State/province [192] 0 0
Morelos
Country [193] 0 0
Mexico
State/province [193] 0 0
Nuevo León
Country [194] 0 0
Mexico
State/province [194] 0 0
Sinaloa
Country [195] 0 0
Mexico
State/province [195] 0 0
Sonora
Country [196] 0 0
Mexico
State/province [196] 0 0
Tamaulipas
Country [197] 0 0
Mexico
State/province [197] 0 0
Veracruz
Country [198] 0 0
Mexico
State/province [198] 0 0
Yucatán
Country [199] 0 0
Mexico
State/province [199] 0 0
Aguascalientes
Country [200] 0 0
Mexico
State/province [200] 0 0
Chihuahua
Country [201] 0 0
Mexico
State/province [201] 0 0
Cuauhtémoc
Country [202] 0 0
Mexico
State/province [202] 0 0
Durango
Country [203] 0 0
Mexico
State/province [203] 0 0
Querétaro
Country [204] 0 0
Netherlands
State/province [204] 0 0
Drenthe
Country [205] 0 0
Netherlands
State/province [205] 0 0
Gelderland
Country [206] 0 0
Netherlands
State/province [206] 0 0
Noord-Brabant
Country [207] 0 0
Netherlands
State/province [207] 0 0
Noord-Holland
Country [208] 0 0
Netherlands
State/province [208] 0 0
Overijssel
Country [209] 0 0
Netherlands
State/province [209] 0 0
Utrecht
Country [210] 0 0
Netherlands
State/province [210] 0 0
Zuid-Holland
Country [211] 0 0
Netherlands
State/province [211] 0 0
Groningen
Country [212] 0 0
Poland
State/province [212] 0 0
Dolnoslaskie
Country [213] 0 0
Poland
State/province [213] 0 0
Kujawsko-pomorskie
Country [214] 0 0
Poland
State/province [214] 0 0
Lubelskie
Country [215] 0 0
Poland
State/province [215] 0 0
Mazowieckie
Country [216] 0 0
Poland
State/province [216] 0 0
Mazowiecki
Country [217] 0 0
Poland
State/province [217] 0 0
Malopolskie
Country [218] 0 0
Poland
State/province [218] 0 0
Podlaskie
Country [219] 0 0
Poland
State/province [219] 0 0
Pomorskie
Country [220] 0 0
Poland
State/province [220] 0 0
Warminsko-mazurskie
Country [221] 0 0
Poland
State/province [221] 0 0
Wielkopolskie
Country [222] 0 0
Poland
State/province [222] 0 0
Lódzkie
Country [223] 0 0
Poland
State/province [223] 0 0
Slaskie
Country [224] 0 0
Puerto Rico
State/province [224] 0 0
Bayamon
Country [225] 0 0
Puerto Rico
State/province [225] 0 0
Dorado
Country [226] 0 0
Puerto Rico
State/province [226] 0 0
Manati
Country [227] 0 0
Puerto Rico
State/province [227] 0 0
Ponce
Country [228] 0 0
Puerto Rico
State/province [228] 0 0
San Juan
Country [229] 0 0
Romania
State/province [229] 0 0
Arge?
Country [230] 0 0
Romania
State/province [230] 0 0
Bihor
Country [231] 0 0
Romania
State/province [231] 0 0
Bra?ov
Country [232] 0 0
Romania
State/province [232] 0 0
Bucure?ti
Country [233] 0 0
Romania
State/province [233] 0 0
Constan?a
Country [234] 0 0
Romania
State/province [234] 0 0
Dolj
Country [235] 0 0
Romania
State/province [235] 0 0
Maramure?
Country [236] 0 0
Romania
State/province [236] 0 0
Mure?
Country [237] 0 0
Romania
State/province [237] 0 0
Prahova
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Romania
State/province [238] 0 0
Timi?
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Romania
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Bacau
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Romania
State/province [240] 0 0
Gala?i
Country [241] 0 0
Romania
State/province [241] 0 0
Ia?i
Country [242] 0 0
Romania
State/province [242] 0 0
Satu Mare
Country [243] 0 0
Romania
State/province [243] 0 0
Sibiu
Country [244] 0 0
Slovakia
State/province [244] 0 0
Nitriansky Kraj
Country [245] 0 0
Slovakia
State/province [245] 0 0
Trenciansky Kraj
Country [246] 0 0
Slovakia
State/province [246] 0 0
Trnavský Kraj
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Slovakia
State/province [247] 0 0
Bratislava
Country [248] 0 0
Slovakia
State/province [248] 0 0
Zilina
Country [249] 0 0
Slovakia
State/province [249] 0 0
Žilinský Kraj
Country [250] 0 0
Spain
State/province [250] 0 0
A Coruña [La Coruña]
Country [251] 0 0
Spain
State/province [251] 0 0
Almería
Country [252] 0 0
Spain
State/province [252] 0 0
Andalucía
Country [253] 0 0
Spain
State/province [253] 0 0
Asturias, Principado De
Country [254] 0 0
Spain
State/province [254] 0 0
Balears [Baleares]
Country [255] 0 0
Spain
State/province [255] 0 0
Barcelona [Barcelona]
Country [256] 0 0
Spain
State/province [256] 0 0
Cantabria
Country [257] 0 0
Spain
State/province [257] 0 0
Castilla Y
Country [258] 0 0
Spain
State/province [258] 0 0
Catalunya [Cataluña]
Country [259] 0 0
Spain
State/province [259] 0 0
Cádiz
Country [260] 0 0
Spain
State/province [260] 0 0
Lleida [Lérida]
Country [261] 0 0
Spain
State/province [261] 0 0
Madrid, Comunidad De
Country [262] 0 0
Spain
State/province [262] 0 0
Madrid
Country [263] 0 0
Spain
State/province [263] 0 0
Navarra
Country [264] 0 0
Spain
State/province [264] 0 0
Santa Cruz De Tenerife
Country [265] 0 0
Spain
State/province [265] 0 0
Sevilla
Country [266] 0 0
Spain
State/province [266] 0 0
Valenciana, Comunitat
Country [267] 0 0
Spain
State/province [267] 0 0
València
Country [268] 0 0
Spain
State/province [268] 0 0
Granada
Country [269] 0 0
Spain
State/province [269] 0 0
Málaga
Country [270] 0 0
Taiwan
State/province [270] 0 0
Hsinchu
Country [271] 0 0
Taiwan
State/province [271] 0 0
Kaohsiung
Country [272] 0 0
Taiwan
State/province [272] 0 0
New Taipei
Country [273] 0 0
Taiwan
State/province [273] 0 0
Tainan
Country [274] 0 0
Taiwan
State/province [274] 0 0
Taipei
Country [275] 0 0
Taiwan
State/province [275] 0 0
New Taipei City
Country [276] 0 0
Turkey
State/province [276] 0 0
Adana
Country [277] 0 0
Turkey
State/province [277] 0 0
Bursa
Country [278] 0 0
Turkey
State/province [278] 0 0
Istanbul
Country [279] 0 0
Turkey
State/province [279] 0 0
Izmir
Country [280] 0 0
Turkey
State/province [280] 0 0
Ankara
Country [281] 0 0
Turkey
State/province [281] 0 0
Antalya
Country [282] 0 0
Turkey
State/province [282] 0 0
Aydin
Country [283] 0 0
Turkey
State/province [283] 0 0
Denizli
Country [284] 0 0
Turkey
State/province [284] 0 0
Gaziantep
Country [285] 0 0
Turkey
State/province [285] 0 0
Kayseri
Country [286] 0 0
Turkey
State/province [286] 0 0
Konya
Country [287] 0 0
Turkey
State/province [287] 0 0
Malatya
Country [288] 0 0
Turkey
State/province [288] 0 0
Mersin
Country [289] 0 0
Turkey
State/province [289] 0 0
Sivas
Country [290] 0 0
United Kingdom
State/province [290] 0 0
Angus
Country [291] 0 0
United Kingdom
State/province [291] 0 0
Bristol, City Of
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Cambridgeshire
Country [293] 0 0
United Kingdom
State/province [293] 0 0
Cornwall
Country [294] 0 0
United Kingdom
State/province [294] 0 0
Devon
Country [295] 0 0
United Kingdom
State/province [295] 0 0
England
Country [296] 0 0
United Kingdom
State/province [296] 0 0
Hertfordshire
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Kingston Upon
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Lancashire
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Leicestershire
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Suffolk
Country [301] 0 0
United Kingdom
State/province [301] 0 0
Coventry
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Newcastle upon Tyne
Country [303] 0 0
United Kingdom
State/province [303] 0 0
Rotherham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


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/NCT05556512