No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Other
Participants needed
8 (estimated)
Sponsor
University of New Mexico · Other
Who this trial is looking for
This trial is looking for adults with obesity and liver disease to see how tirzepatide affects their liver health. Participants will take the medication for a year and have check-ups every three months.
Are You a Good Fit for This Trial?
Rules you outDecompensated liver diseasePregnancyBreastfeedingPancreatitisActive malignancyDecompensated heart failure
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD).
I have a BMI greater than 25.
I can speak English.
You may not be able to join if
I am pregnant or breastfeeding.
I drink more than 50 grams of alcohol a day.
I have a history of pancreatitis.
I have any type of advanced liver disease.
I have an active cancer diagnosis.
I have had a serious heart issue recently.
I am taking other weight loss medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is…
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD.
Participants will be asked to:
* Take tirzepatide for 12 months.
* Come in for clinic visits every 3 months.
* Have blood drawn at baseline, 6, and 12 months.
* Complete a liver ultrasound at baseline and at 12 months.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Men and women
* Age 18-75
* Diagnosis of MASLD based on the following criteria:
* Presence of at least 1 out of the 5 following cardiometabolic criteria:
* BMI \>25 kg/m2 OR waist circumference \>94 cm (men) or 80cm (women)
* Fasting serum glucose \>100 mg/dL OR 2-hour post…
Inclusion Criteria:
* Men and women
* Age 18-75
* Diagnosis of MASLD based on the following criteria:
* Presence of at least 1 out of the 5 following cardiometabolic criteria:
* BMI \>25 kg/m2 OR waist circumference \>94 cm (men) or 80cm (women)
* Fasting serum glucose \>100 mg/dL OR 2-hour post-prandial glucose levels \>140mg/dL OR AbA1c \>5.7% OR type 2 diabetes OR treatment for type 2 diabetes
* Blood pressure \>130/85 mmHg OR specific antihypertensive drug treatment
* Plasma triglycerides \>150mg/dL OR on lipid lowering treatment
* Plasma HDL-cholesterol \<40mg/dL (men) and \<50mg/dL (women) OR on lipid lowering medication
* No other identified causes of steatosis
* Evidence of steatotic liver disease (hepatic steatosis identified by imaging or biopsy)
* English speaking
Exclusion Criteria:
* Pregnancy or breast feeding
* Premenopausal women not on any form of contraception
* Reports alcohol intake \>50g/day or 350g/week for women and \>60g/day or 420g/week for men or an AUDIT score \>8
* Other identifiable causes of steatosis
* Documented allergic reaction to tirzepatide or any other GLP1 RA
* Decompensated liver disease
* Decompensated renal disease requiring hemodialysis
* Decompensated heart failure
* Active malignancy
* Prior history of pancreatitis
* Serum triglyceride levels \>500 mg/dL
* Personal or family history of medullary thyroid cancer or MEN2a or MEN2b
* Concurrent use of other ant-obesity medications
* Use of other GLP1 RAs within 3 months of study enrollment
* Unable to obtain the medication due to cost or insurance coverage restrictions.
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