Is NCT07046819 recruiting in Bethesda, MD?

Yes, NCT07046819 is currently recruiting participants at its Bethesda, MD location. This metabolic alcohol-associated liver disease clinical trial is actively enrolling qualified participants.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metabolic Alcohol-associated Liver Disease Clinical Trial in Bethesda, MD

Q: How do I join the metabolic alcohol-associated liver disease clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Metabolic Alcohol-associated Liver Disease Study in Bethesda

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.

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who Can Participate

Inclusion Criteria

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

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

Exclusion Criteria

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT07046819) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metabolic Alcohol-associated Liver Disease Treatment Options in Bethesda, MD

If you're searching for metabolic alcohol-associated liver disease treatment options in Bethesda, MD, this clinical trial (NCT07046819) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metabolic alcohol-associated liver disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metabolic alcohol-associated liver disease clinical trials near you to find additional studies recruiting in your area.

Metabolic Alcohol-associated Liver Disease Clinical Trial in Bethesda, MD

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