Diabetes Mellitus, Type 2DUP-STEP-HFpEFNCT06914102
Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data
An observational study of Diabetes Mellitus, Type 2 and HFpEF - Heart Failure With Preserved Ejection Fraction, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58,387 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population included individuals aged 18 years or older with heart failure with preserved ejection fraction when following and relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Who may be able to join
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- BMI ≥ 30.0 kg/m2
- NYHA Class II-IV
- LVEF ≥ 45%
- No hospitalizations due to heart failure between screening (V1) and randomization (V2)
- At least one of the following:
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- If BMI <35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NTproBNP ≥660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients with sinus rhythm) or NTproBNP ≥ 375 pg/mL (for patients with persistent/permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening): i. Septal é < 7cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15 ii. PA systolic pressure >35mmHg iii. Left atrial (LA) enlargement (LA width ≥3.8 cm or LA length ≥ 5.0cm or LA area ≥ 20.0cm2 or LA volume ≥ 55mL or LA volume index ≥29mL/m2) iv. LV hypertrophy with septal thickness or posterior wall thickness ≥1.2cm
- Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening): i. Septal é < 7cm/sec or lateral é < 10cm/sec or average E/é ≥15 ii. PA systolic pressure >35mmHg iii. LA enlargement (LA width ≥3.8cm or LA length ≥ 5.0cm or LA area ≥20.0cm2 or LA volume ≥ 55mL or LA volume index ≥ 29mL/m2) iv. LV hypertrophy with septal thickness or posterior wall thickness ≥1.2cm
- Diagnosed with T2D ≥ 90 days prior to the day of screening.
- Subject treated with diet, exercise, and/or antidiabetic treatment* according to local label in stable dosing for at least 30 days prior to screening: o *OAD(s): unchanged drug(s), dose and dosing frequency o *Insulin(s): unchanged regimen (basal, basal + bolus, premix combination) with stable total daily insulin dose as judged by the investigator
- Men or women ≥ 18 years old
- History of type 2 diabetes mellitus
- BMI ≥ 27.0 kg/m2
- Heart failure
- Preserved ejection fraction
Who cannot join
- Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- Systolic blood pressure > 160 mmHg at screening.
- Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g. amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
- Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
- History of type 1 diabetes (history of gestational diabetes is allowed).
- Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.
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- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- Recurrent severe hypoglycemic episodes within the last year as judged by the investigator.
- Treatment with continuous subcutaneous insulin infusion
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Presence of acute pancreatitis within the last 180 days prior to screening.
- History or presence of chronic pancreatitis.
- End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.
- Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
- RELAXING ELIGIBILITY OF THE STEP-HFpEF DM TRIAL
- Prior treatment with any GLP-1-RA
- History of type 1 diabetes mellitus
- End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis
- History of bariatric surgery
- History of nursing home admission
- Pregnant female or breast-feeding
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
- Treatment with continuous subcutaneous insulin infusion
- Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to emulate, as closely as is possible in healthcare insurance claims data, the STEP-HFpEF DM trial described below. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. In addition to closely emulating the trial population, this study also evaluates outcomes in a broader, less restrictive cohort to enhance generalizability to patients typically encountered in routine clinical practice.
Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides guidance on the reference standard treatment effect estimate. However, failure to replicate RCT findings is not necessarily indicative of the inadequacy of the healthcare claims data for emulation for a range of possible reasons, as the end points examined in the database study were only of exploratory nature in the trial. Moreover, divergence from these end points do not provide information on the validity of the original RCT finding.
The STEP-HFpEF DM trial is a superiority trial that included an evaluation of the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1-RA), vs placebo on all-cause mortality or worsening heart failure events among individuals with heart failure with preserved ejection fraction.
The database study designed to emulate STEP-HFpEF DM will be a new-user active-comparative study, conducted using 3 national United States claims databases, where we compare the effect of semaglutide vs sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP4i) on the composite end point of all-cause mortality or heart failure hospitalization. While the STEP-HFpEF DM trial compared semaglutide vs placebo, we chose to use sitagliptin as an active-comparator proxy for placebo. Sitagliptin was specifically chosen because a major randomized controlled trial on cardiovascular outcomes demonstrated that the drug does not affect the cardiovascular outcomes under investigation. Furthermore, clinical guidelines during the study period recommended both drug classes under investigation as second- or third-line options for glucose lowering and were similarly costly
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
New use of semaglutide dispensing claim is used as the exposure.
PlaceboDrug
New use of sitagliptin dispensing claim is used as the reference (active-comparator proxy for placebo).
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Exposure group Receives: Drug: Semaglutide | |
| Placebo | Reference group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality or heart failure hospitalization
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on composite of all-cause mortality or heart failure hospitalization in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Secondary outcomes (8)
Composite of all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting), and its respective individual end points.
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting) in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting)
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting) in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Intravenous diuretic therapy in an urgent care setting
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on intravenous diuretic therapy in an urgent care setting in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Hospitalization for heart failure
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on hospitalization for heart failure in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
All-cause mortality
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on all-cause mortality in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Urinary tract infection
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on urinary tract infection in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Serious bacterial infection
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on serious bacterial infection in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Gastrointestinal adverse events
To evaluate the effect of semaglutide vs placebo (sitagliptin) on gastrointestinal adverse events in two populations: (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Measured: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start14 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's HospitalNils Krüger, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914102
- Sponsor's protocol ID
- 2018P002966-DUP-STEP-HFpEF
- Acronym
- DUP-STEP-HFpEF
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kruger N, Schneeweiss S, Fuse K, Matseyko S, Sreedhara SK, Hahn G, Schunkert H, Wang SV. Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction. JAMA. 2025 Oct 14;334(14):1255-1266. doi: 10.1001/jama.2025.14092.
PubMed 40886075
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT06914102
- Acronym / sponsor ID
- DUP-STEP-HFpEF / 2018P002966-DUP-STEP-HFpEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58,387 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to emulate, as closely as is possible in healthcare insurance claims data, the STEP-HFpEF DM trial described below. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. In addition to closely emulating the trial population, this study also evaluates outcomes in a broader, less restrictive cohort to enhance generalizability to patients typically encountered in routine clinical practice.
Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides guidance on the reference standard treatment effect estimate. However, failure to replicate RCT findings is not necessarily indicative of the inadequacy of the healthcare claims data for emulation for a range of possible reasons, as the end points examined in the database study were only of exploratory nature in the trial. Moreover, divergence from these end points do not provide information on the validity of the original RCT finding.
The STEP-HFpEF DM trial is a superiority trial that included an evaluation of the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1-RA), vs placebo on all-cause mortality or worsening heart failure events among individuals with heart failure with preserved ejection fraction.
The database study designed to emulate STEP-HFpEF DM will be a new-user active-comparative study, conducted using 3 national United States claims databases, where we compare the effect of semaglutide vs sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP4i) on the composite end point of all-cause mortality or heart failure hospitalization. While the STEP-HFpEF DM trial compared semaglutide vs placebo, we chose to use sitagliptin as an active-comparator proxy for placebo. Sitagliptin was specifically chosen because a major randomized controlled trial on cardiovascular outcomes demonstrated that the drug does not affect the cardiovascular outcomes under investigation. Furthermore, clinical guidelines during the study period recommended both drug classes under investigation as second- or third-line options for glucose lowering and were similarly costly
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | – | Drug: SemaglutideExposure group |
| Placebo | – | Drug: PlaceboReference group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included individuals aged 18 years or older with heart failure with preserved ejection fraction when following and relaxing the eligibility criteria of the STEP-HFpEF DM trial.
Key inclusion criteria (15 listed)
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- BMI ≥ 30.0 kg/m2
- NYHA Class II-IV
- LVEF ≥ 45%
- No hospitalizations due to heart failure between screening (V1) and randomization (V2)
Key exclusion criteria (27 listed)
- Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- Systolic blood pressure > 160 mmHg at screening.
- Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g. amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate heart valve disease).
- Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
- History of type 1 diabetes (history of gestational diabetes is allowed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideNew use of semaglutide dispensing claim is used as the exposure. | Drug | Semaglutide |
| PlaceboNew use of sitagliptin dispensing claim is used as the reference (active-comparator proxy for placebo). | Drug | Placebo |
Primary outcome
Composite of all-cause mortality or heart failure hospitalization
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
To evaluate the effect of semgalutide vs placebo (sitaglitpin) on composite of all-cause mortality or heart failure hospitalization in two populations (1) patients meeting the eligibility criteria of the STEP-HFpEF DM trial, and (2) a broader patient population when relaxing the eligibility criteria of the STEP-HFpEF DM trial.
8 secondary outcomes
Composite of all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting), and its respective individual end points.
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting)
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Intravenous diuretic therapy in an urgent care setting
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Hospitalization for heart failure
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
All-cause mortality
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Urinary tract infection
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Serious bacterial infection
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Gastrointestinal adverse events
Time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 40886075Kruger N, Schneeweiss S, Fuse K, Matseyko S, Sreedhara SK, Hahn G, Schunkert H, Wang SV. Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction. JAMA. 2025 Oct 14;334(14):1255-1266. doi: 10.1001/jama.2025.14092.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
Nils Krüger, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and HFpEF - Heart Failure With Preserved Ejection Fraction, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality or heart failure hospitalization (time frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.