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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

SYNERGY-NASH Trial Summary

This trial will test if a new drug is safe and effective in treating NASH.

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.Check my eligibility
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.See study design
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.

SYNERGY-NASH Trial Eligibility Criteria

Inclusion Criteria

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

SYNERGY-NASH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fibrosis
Secondary outcome measures
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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

SYNERGY-NASH 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
~5780

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,622 Previous Clinical Trials
3,216,579 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
1,349 Previous Clinical Trials
415,702 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
288 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04166773 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, 15 mg Tirzepatide, 10 mg Tirzepatide, 5 mg Tirzepatide
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT04166773 — Phase 2
Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166773 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04166773 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How perilous is the utilization of Tirzepatide for individuals?

"The safety of Tirzepatide is estimated at a 2 on our 1-3 scale, since it has only been through Phase 2 trials with safety data but no evidence as to its efficacy yet."

Answered by AI

What is the sample size of this trial's participants?

"To fulfill the requirements of this medical trial, 196 candidates need to be recruited from designated sites such as Southern Therapy and Advanced Research (STAR) LLC in Jackson, Mississippi and Geisinger Clinic in Danville, Pennsylvania."

Answered by AI

Does this experimental protocol accept participants below the age of eighty?

"Per the terms of this clinical trial, individuals 18 years or older and no more than 80 are eligible for enrollment."

Answered by AI

Is this research endeavor actively searching for participants?

"As per the details found on clinicaltrials.gov, this experiment is actively searching for participants. It was posted to the site initially on November 19th 2019 and had its most recent edit occur in November 23rd 2022."

Answered by AI

Is this research endeavor operational in a substantial number of locations within the United States?

"This clinical trial is currently accepting participants at 54 distinct sites, such as the Southern Therapy and Advanced Research (STAR) LLC in Jackson, Geisinger Clinic in Danville, and Inland Empire Liver Foundation in Rialto."

Answered by AI

Have any other investigations explored the effects of Tirzepatide?

"Tirzepatide was initially trialled in 2019 at Queen's Medical Centre, Nottingham University Hospitals. As of this time there have been 18335 completed studies and 10 more presently recruiting patients; many of these trials are being run out of Jackson, Mississippi."

Answered by AI

Is this a pioneering attempt to test the effectiveness of a new treatment?

"At present, there are 10 active Tirzepatide trials occurring across 626 cities and 31 countries. These studies began in 2019 under the auspices of Eli Lilly and Company with 196 participants for Phase 2 drug approval. Since its launch three years ago, 18335 trials have been concluded."

Answered by AI

What criteria must potential participants meet to enroll in this clinical research?

"This clinical trial is recruiting 196 individuals with non alcoholic steatohepatitis (NASH), aged 18-80. Candidates must meet the following qualifications: no alcohol consumption above 14 units/week for women and 21 units/week for men, body mass index between 27 to 50 kg/m² without any changes in weight over a 3 month period, not having active cancer within 5 years of registration, not being hospitalised due to congestive heart failure or other cardiovascular diseases in the past 6 months, controlled blood pressure levels and absence of cirrhosis or liver disease."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Iowa
Other
Illinois
How old are they?
18 - 65
What site did they apply to?
Iowa Diabetes and Endocrinology Research Center
Diabetes & Endocrinology Consultants, PC
Synexus Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Want to reverse fibrosis. I have been diagnosed with fatty liver disease. I want to improve my liver health and stop any further deterioration.
PatientReceived no prior treatments
I have Non-Alcoholic fatty liver disease and want to improve my life. Interested in improving my health and dealing with Type 2 Diabetes issues.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Where is your trial in Chicago?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
2019. "A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04166773.
~36 spots leftby May 2025
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