Metabolic Alcohol-associated Liver DiseasePhase 2NCT07046819
Tirzepatide in MetALD
A Phase 2 study testing Tirzepatide in people with Metabolic Alcohol-associated Liver Disease and Alcohol Use Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Metabolic Alcohol-associated Liver Disease, Alcohol Use Disorder
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to 30 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 21 or older
- Ability to provide written informed consent
- Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an approved IUD or other longacting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s)
- Males: Agree to abstain or use accepted form of contraception, such as condoms.
- Diagnosis of AUD as confirmed by MINI
Show all 15Show fewer
- Current alcohol use as assessed via the TLFB (>14 standard drinks per week for males and >7 standard drinks per week for females on average for the last 8 weeks)
- Liver steatosis as determined by Fibroscan (CAP score >240) at screening
- BMI >= 25 and <40 kg/m^2
- metALD as defined by at least one out of 5 criteria at screening:
- BMI >= 25 and <40 kg/m^2
- Fasting serum glucose >= 5.6mmol/L [100mg/dL] or HbA1c >=5.7%
- Blood pressure >=130/85 or specific antihypertensive drug treatment
- Plasma triglycerides >=1.70mmol/L [150mg/dL] or lipid lowering treatment
- Plasma HDL-cholesterol less than 1.0mmol/L [40mg/dL] or lipid lowering treatment
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Treatment seeking for alcohol use disorder
- History of a serious hypersensitivity reaction to GLP-1RA/GIPRA
- Current/past use of GLP-1RA/GIPRA within the last 3 months
- Clinically significant and/or unstable cardiovascular disease over the past 12 months
- History of diabetes mellitus or blood hemoglobin A1c (HbA1c) >= 6.5 % at screening
Show all 28Show fewer
- Any underlying clinically significant and/or unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices
- Subjects with platelets count of less than 110,000/ mm^3
- Alanine aminotransferase or aspartate aminotransferase exceeding 5 times the upper limit of normal levels at screening
- Bilirubin 2x UNL or Creatinine > 2 mg/dL at screening
- Patients with coagulopathy defined as INR >1.5, prothrombin time prolonged by > 3s, and/or platelets <75,000 / mm^3 at screening
- Positive HIV test or positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at screening
- Chronic renal failure as estimated by glomerular filtration rate (GFR) < 60mL/min/1.73 m^2 at screening
- History of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of previous bariatric surgery or transplant surgery
- Patients with significant hematologic abnormalities, as defined by hemoglobin < 8g/dL and/or white blood count <1500 cells/microL
- Current or prior history of any clinically significant disease, including, seizure disorder, epilepsy, alcohol related seizures within 12 months of screening, uncontrolled endocrine disease, hemorrhagic stroke, cancer within the past 5 years or any other significant abnormality identified at the time of screening that, in the judgment of the investigator or study clinician, would preclude safe completion of the study
- Use of any medications that interfere with tirzepatide
- Use of the following medications with glucose lowering properties in the last 30 days: GLP-1RA, GLP-1RA/GIPRA, insulin, metformin, sulfonylurea, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors
- Use of the following medications: Any medication that requires intramuscular administration injections. Systemic corticosteroids
- Use of any investigational drugs within 1 month, or five half-lives, whichever is longer, of the study procedures
- Presence of any current suicidality or a lifetime history of suicide attempt or suicidal ideation within the past year
- History of serious mental illnesses including psychotic disorders, bipolar disorders, severe anxiety, mood, or trauma-related disorders and other psychiatric conditions which in the opinion of the investigators would impede the patient's participation or compliance in the study
- History of liver decompensation events such as hepatic encephalopathy or ascites
- History of severe gastroparesis
- History of pancreatitis in the last 5 years or if subject has chronic pancreatitis
- For optional MRI: a) Presence of ferromagnetic objects in the body that may be adversely affected by or contraindicated for MRI, fear of enclosed spaces, or other standard contraindication to MRI, as determined by self-report b) Use of MRI- incompatible intrauterine device (IUD).
- Individuals who are pregnant or breastfeeding, or with severe hepatic or renal liver impairment will be excluded from this study because there is no clinical data on the safety of tirzepatide in these populations, including the impact on the fetus or infant. To assess pregnancy status, participants who can become pregnant will be required to take a urine pregnancy test and to test negative before administering study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
Section on Clinical Genomics & Experimental Therapeutics, (240) 731-9681, NIAAACGETResearch@mail.nih.gov
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease
Background:
People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake.
Read more
Objective:
To test Tirzepatide in people with AUD and MetALD.
Eligibility:
People aged 21 years and older with AUD and MetALD.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver.
These tests will be repeated in a baseline visit. This visit will take up to 6 hours.
Tirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours.
All tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.
Read the detailed description
STUDY DESCRIPTION:
The GLP-1/GIP receptor dual agonist tirzepatide has been recently shown to reduce HbA1c in adults with Type 2 diabetes, achieve weight reduction in adults with obesity and reduce metabolic dysfunction associated steatohepatitis. In addition, some data suggest beneficial effects on drinking behaviors. This study will evaluate the efficacy and safety of tirzepatide as a novel treatment for alcohol use disorder (AUD) and metabolic alcohol-associated liver disease (MetALD).
We hypothesize that tirzepatide will be well tolerated and safe in this new target population and that tirzepatide will achieve reduction in alcohol use, metabolic improvement and attenuate alcohol-induced liver steatosis.
OBJECTIVES:
Primary Objective:
The primary objective is to assess the efficacy of tirzepatide in individuals with AUD/MetALD.
Secondary/Exploratory Objectives:
Secondary/exploratory objectives are to assess various biomarkers related to alcohol-induced liver damage, inflammation, neuropsychiatric outcomes, drinking behaviors, epigenetic age acceleration, brain metabolites, and safety.
ENDPOINTS:
Primary endpoints:
- co-primary endpoint: metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score.
Secondary endpoints:
- Reduction in liver steatosis from baseline as measured by MRI spectroscopy
- Reduction in MRI visceral fat from baseline
- Reduction in liver enzymes (ALT, AST, GGT) from baseline
- Reduction in drinking behaviors/cravings from baseline
- Reduction in one WHO risk drinking level
Secondary safety endpoints:
- Safety and tolerability
Exploratory endpoints:
- Effects on biomarkers (i.e. Il-6, FGF21, epigenetic and genetic markers, proteomics, metabolomics)
- Effects on depression and anxiety measures
- Effects on epigenetic age acceleration
- Changes in brain metabolites as measured by MRI spectroscopy
- Changes in resting state functional connectivity
- Being tested
- Tirzepatide, Placebo
- Keywords
- BMI, Weight, Alcohol, Metabolism
- Medical subject headings
- Alcoholism, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.
PlaceboOther
A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks. Receives: Other: Placebo |
| Tirzepatide | Active comparator | A 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score.
Measured: Change from baseline to week 12
Secondary outcomes (1)
Reduction from baseline in - 1) Liver steatosis as measured by MRI spectroscopy, 2) MRI visceral fat, 3) Liver enzymes (ALT, AST, GGT), 4) Drinking behaviors/cravings, 5) WHO risk drinking level
Measured: Change from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start11 Jun 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
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 Metabolic Alcohol-associated Liver DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Falk W Lohoff, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046819
- Sponsor's protocol ID
- 10002246
- Other IDs
- 002246-AA
- Status last verified
- 16 Jul 2026
- First submitted
- 1 Jul 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD relevant to publication will be shared.
Publications
Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.
PubMed 30473097
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease
- ClinicalTrials.gov ID
- NCT07046819
- Acronym / sponsor ID
- 10002246
- Keywords
- BMI, Weight, Alcohol, Metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 2 Jul 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.
Background:
People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake.
Objective:
To test Tirzepatide in people with AUD and MetALD.
Eligibility:
People aged 21 years and older with AUD and MetALD.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver.
These tests will be repeated in a baseline visit. This visit will take up to 6 hours.
Tirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours.
All tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.
Detailed description
STUDY DESCRIPTION:
The GLP-1/GIP receptor dual agonist tirzepatide has been recently shown to reduce HbA1c in adults with Type 2 diabetes, achieve weight reduction in adults with obesity and reduce metabolic dysfunction associated steatohepatitis. In addition, some data suggest beneficial effects on drinking behaviors. This study will evaluate the efficacy and safety of tirzepatide as a novel treatment for alcohol use disorder (AUD) and metabolic alcohol-associated liver disease (MetALD).
We hypothesize that tirzepatide will be well tolerated and safe in this new target population and that tirzepatide will achieve reduction in alcohol use, metabolic improvement and attenuate alcohol-induced liver steatosis.
OBJECTIVES:
Primary Objective:
The primary objective is to assess the efficacy of tirzepatide in individuals with AUD/MetALD.
Secondary/Exploratory Objectives:
Secondary/exploratory objectives are to assess various biomarkers related to alcohol-induced liver damage, inflammation, neuropsychiatric outcomes, drinking behaviors, epigenetic age acceleration, brain metabolites, and safety.
ENDPOINTS:
Primary endpoints:
- co-primary endpoint: metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score.
Secondary endpoints:
- Reduction in liver steatosis from baseline as measured by MRI spectroscopy
- Reduction in MRI visceral fat from baseline
- Reduction in liver enzymes (ALT, AST, GGT) from baseline
- Reduction in drinking behaviors/cravings from baseline
- Reduction in one WHO risk drinking level
Secondary safety endpoints:
- Safety and tolerability
Exploratory endpoints:
- Effects on biomarkers (i.e. Il-6, FGF21, epigenetic and genetic markers, proteomics, metabolomics)
- Effects on depression and anxiety measures
- Effects on epigenetic age acceleration
- Changes in brain metabolites as measured by MRI spectroscopy
- Changes in resting state functional connectivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: PlaceboA 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks. |
| Tirzepatide | Active comparator | Drug: TirzepatideA 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 21 or older
- Ability to provide written informed consent
- Females: Negative urine pregnancy test, not currently breastfeeding, agree to abstain or use accepted form of contraception including use of oral contraceptives and an additional barrier method of contraceptive such as condoms; use of an approved IUD or other longacting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s)
- Males: Agree to abstain or use accepted form of contraception, such as condoms.
Key exclusion criteria (28 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Treatment seeking for alcohol use disorder
- History of a serious hypersensitivity reaction to GLP-1RA/GIPRA
- Current/past use of GLP-1RA/GIPRA within the last 3 months
- Clinically significant and/or unstable cardiovascular disease over the past 12 months
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 |
|---|---|---|
| TirzepatideA 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks. | Drug | Tirzepatide |
| PlaceboA 2.5mg, 5mg, and 7.5mg subcutaneous injection will be given once weekly for 12 weeks. | Other | Saline |
Primary outcome
Metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score.
Time frame: Change from baseline to week 12
1 secondary outcome
Reduction from baseline in - 1) Liver steatosis as measured by MRI spectroscopy, 2) MRI visceral fat, 3) Liver enzymes (ALT, AST, GGT), 4) Drinking behaviors/cravings, 5) WHO risk drinking level
Time frame: Change from baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 30473097Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD relevant to publication will be shared.
Related trials for Metabolic Alcohol-associated Liver Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 3
Apixaban to Prevent Decompensation of Early Liver Cirrhosis Trial
Liver Cirrhosis
Active, not recruitingPhase 2
Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects
MASLD
RecruitingObservational study
Impact of Steatotic Liver Disease Associated With Metabolic Dysfunction (MASLD) on Frailty, Cognition, and Quality of Life. A Gender-sensitive Approach Towards a Comprehensive and Equitable Perspective.
Steatosis of Liver
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
Falk W Lohoff, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Metabolic Alcohol-associated Liver Disease and Alcohol Use Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 28 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: looking for participants now, as of the sponsor's last update on 12 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada M Saleh ((301) 496-3799, nada.saleh@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score. (time frame: Change from baseline to week 12). 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 NCT07046819, 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 12 Aug 2026.