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Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

Effect of Tirzepatide on Markers of MASLD in Patients With Obesity: A Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how tirzepatide affects the liver in adults ages 18–75 with MASLD, a disease that causes fat to build up in the liver. Participants take tirzepatide for 12 months and visit the clinic every 3 months. They also have blood tests and liver ultrasounds, which use sound waves to take pictures.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults ages 18–75 who speak English.
  • Have liver fat shown by a scan or tissue sample, with no other known cause. You must also have at least one of the five health factors below.
  • Body mass index (BMI, a measure of weight for height) over 25, or waist size over 94 cm for men or 80 cm for women.
  • High blood sugar: fasting level over 100 mg/dL, level 2 hours after a meal over 140 mg/dL, or A1c over 5.7%. Having type 2 diabetes or taking medicine for it also counts.
  • Blood pressure over 130/85, or taking medicine for high blood pressure.
  • Triglycerides, a type of blood fat, over 150 mg/dL, or taking medicine to lower blood fats.
  • HDL, or “good” cholesterol, below 40 mg/dL for men or 50 mg/dL for women, or taking medicine to lower blood fats.

Who can't join

  • Pregnant or breastfeeding, or a woman who has not gone through menopause and is not using birth control.
  • Alcohol use over 50 grams a day or 350 grams a week for women, or over 60 grams a day or 420 grams a week for men; or a score over 8 on the AUDIT alcohol-use screening test.
  • Another known cause of liver fat, or severe liver disease where the liver can no longer work well.
  • Severe kidney disease needing hemodialysis, a treatment that filters the blood, or heart failure that is no longer controlled.
  • Active cancer, or a personal or family history of medullary thyroid cancer or MEN2a or MEN2b, conditions that can cause tumors in hormone-making glands.
  • An allergy to tirzepatide or another GLP-1 medicine; past pancreatitis, or swelling of the pancreas; or triglycerides over 500 mg/dL.
  • Taking another weight-loss medicine, or having used another GLP-1 medicine within 3 months before joining.
  • Unable to get tirzepatide because of its cost or insurance limits.

Simplified for readability. The official criteria below are what the study team uses.

Official 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-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.

Study sites (1)

NM