Recruiting EARLY_PHASE1 MASLD

New treatment option for MASLD

Official title Effect of Tirzepatide on Markers of MASLD in Patients With Obesity

ClinicalTrials.gov ID: NCT06934642

What this study is testing

What is Tirzepatide?

Tirzepatide is an investigational medicine, being studied as a potential treatment for masld.

Also referred to as Zepbound, Mounjaro.

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
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • 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)

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Albuquerque, New Mexico, United States

Compensation & support

A stipend or compensation may be offered.

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, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Albuquerque, New Mexico, 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.