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New treatment option for Metabolic Alcohol-associated Liver Disease
Official title Tirzepatide in MetALD
ClinicalTrials.gov ID: NCT07046819
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for metabolic alcohol-associated liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 100
You may be able to join if
- 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...
- Males: Agree to abstain or use accepted form of contraception, such as condoms.
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
- people 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.