Study S000031

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04166773
Acronym: SYNERGY-NASH
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 190
Start: 2019-11-19
Primary completion: 2023-12-11
Lead sponsor: Eli Lilly and Company
Conditions: Nonalcoholic Steatohepatitis
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:I8F-MC-GPHR; EUDRACT_NUMBER:2019-001550-26; NIH:2019

Registered primary outcomes

Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology [Week 52]

Linked records (7)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0006829	Efficacy of tirzepatide, lanifibranor, and resmetirom in metabolic dysfunction-associated steatotic liver disease: a meta-analysis of high-quality randomized controlled trials. Zhao S, Internal and emergency medicine	2026	Systematic review	PMID 41917519 DOI	cites ClinicalTrials.gov:NCT04166773
R0016154	Relationship Between Metabolic and Histological Responses in People With Metabolic Dysfunction- Associated Steatohepatitis With and Without Type 2 Diabetes: Participant-Level Exploratory Analysis of the SYNERGY-NASH Trial With Tirzepatide. Caussy C, Diabetes care	2025	Randomized trial	PMID 41066427 DOI	cites ClinicalTrials.gov:NCT04166773
R0050967	Tirzepatide for the treatment of metabolic dysfunction-associated steatohepatitis with liver fibrosis: results of the SYNERGY-NASH phase 2 trial Rohit S. Loomba, Diabetologie und Stoffwechsel	2025	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04166773
R0018381	Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis. Loomba R, The New England journal of medicine	2024	Randomized trial	PMID 38856224 DOI	cites ClinicalTrials.gov:NCT04166773; registry reference DERIVED:38856224
R0036204	Evaluating the Therapeutic Potential of Tirzepatide in Liver Diseases: A Comprehensive Review Bryan, Carina, NSUWorks (Nova Southeastern University)	2024	Other trial		cites ClinicalTrials.gov:NCT04166773
R0013790	Research Progress on the GIP/GLP-1 Receptor Coagonist Tirzepatide, a Rising Star in Type 2 Diabetes. Ma Z, Journal of diabetes research	2023	Narrative review	PMID 37096236 DOI	cites ClinicalTrials.gov:NCT04166773
R0040528	From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis Manik Aggarwal, Clinical Liver Disease	2023	Other	PMID 36938314 DOI	cites ClinicalTrials.gov:NCT04166773