What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) that are similar to Tirzepatide, such as GLP-1 receptor agonists, often have side effects including gastrointestinal symptoms like nausea, vomiting, and diarrhea. There is also a potential risk for pancreatitis and, in rare cases, pancreatic cancer. Other side effects may include injection site reactions and, less commonly, gallbladder-related issues such as cholelithiasis. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks of the treatment.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH). However, drugs like GLP-1 receptor agonists, which are used for type 2 diabetes and obesity, have shown potential benefits in treating NAFLD due to their effects on weight loss and metabolic parameters. Tirzepatide, a dual GIP and GLP-1 receptor agonist, is currently being studied for its efficacy in treating NASH, reflecting a growing interest in using incretin-based therapies for liver-related metabolic disorders.

What other types of research exist?

Promising alternatives to Tirzepatide for NAFLD patients include: 1) Liraglutide, a GLP-1 receptor agonist, which has shown efficacy in improving liver histology in NASH patients. 2) Pioglitazone, a thiazolidinedione, which has demonstrated benefits in patients with NASH and type 2 diabetes. 3) Semaglutide, another GLP-1 receptor agonist, which has been effective in glycemic control and weight loss, potentially benefiting NAFLD patients. These alternatives offer different mechanisms of action and have shown positive outcomes in related conditions.

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Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Tirzepatide for Non-alcoholic Fatty Liver Disease (SYNERGY-NASH Trial)

Phase 2

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be willing to undergo baseline and endpoint liver biopsies

Be older than 18 years old

Must not have

Participants must not have a diagnosis of type 1 diabetes

Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Summary

This trial is testing if a medication called tirzepatide, taken regularly, is safe and effective for people with Nonalcoholic Steatohepatitis (NASH). NASH is a liver condition that can be hard to treat. Tirzepatide helps control blood sugar and reduce fat in the liver, which may improve liver health. Tirzepatide has shown effectiveness in treating obesity and diabetes.

Who is the study for?

This trial is for adults with Nonalcoholic Steatohepatitis (NASH) who have a BMI of 27-50, stable weight for the past 3 months, and if diabetic, controlled HbA1c levels. They must not have had recent severe cardiovascular events or active cancer in the last 5 years and should be willing to undergo liver biopsies.

What is being tested?

The study tests Tirzepatide's safety and effectiveness against NASH. Participants will receive either Tirzepatide or a placebo once weekly. The trial includes people with varying stages of fibrosis due to NASH, some may also have type 2 diabetes.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with medications like Tirzepatide could include gastrointestinal issues such as nausea or diarrhea, potential low blood sugar especially in those with diabetes, injection site reactions, and possible thyroid tumors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You haven't had a heart attack, stroke, or been hospitalized for heart failure in the past 6 months.

Select...

You have never had pancreatitis (a condition that affects the pancreas).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fibrosis

Secondary study objectives

Mean Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

Mean Change from Baseline in Body Weight

Percentage of Participants that Achieve a ≥2 Point Decrease in NAFLD (non-alcoholic fatty liver disease) Activity Score (NAS) on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components

+2 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 5 mg TirzepatideExperimental Treatment1 Intervention

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Group II: 15 mg TirzepatideExperimental Treatment1 Intervention

15 mg tirzepatide administered SC once a week.

Group III: 10 mg TirzepatideExperimental Treatment1 Intervention

10 mg tirzepatide administered SC once a week.

Group IV: PlaceboPlacebo Group1 Intervention

Placebo administered SC once a week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include GLP-1 receptor agonists and dual GIP and GLP-1 receptor agonists like Tirzepatide. These medications work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which collectively improve glycemic control and promote weight loss. This is particularly important for NAFLD patients as improved glucose metabolism and reduced body weight can significantly decrease liver fat and inflammation, thereby mitigating disease progression.