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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 belowExclusion 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
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 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
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
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.
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,826 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
381 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
426,451 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
288 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You haven't had a heart attack, stroke, or been hospitalized for heart failure in the past 6 months.You have never had pancreatitis (a condition that affects the pancreas).People with or without type 2 diabetes.You must not drink more than 14 units of alcohol per week if you are a woman or more than 21 units per week if you are a man. You should also not be actively using drugs or substances.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 15 mg Tirzepatide
- Group 3: 10 mg Tirzepatide
- Group 4: 5 mg Tirzepatide
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04166773 — Phase 2
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