Trial · NCT04166773
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT04166773, Phase 2, Completed, Eli Lilly and Company; results first posted 2025-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT04166773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04166773
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT04166773
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 190 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- Tirzepatide, Placebo
- First posted
- 2019-11-18
- Last updated
- 2025-01-24
- Other registries' IDs
- eudract:2019-001550-26
- Results first posted
- 2025-01-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | Week 52 | NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52. |
| Secondary | Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology | Week 52 | NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of NASH (defined as no increase in the NAS score). |
| Secondary | Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology | Week 52 | Participants were evaluated with the NASH CRN scoring system with ≥1 stage increase in fibrosis. |
| Secondary | 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 | Week 52 | Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in at least 2 NAS components (lobular inflammation, hepatocellular ballooning or steatosis). The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8, with the higher score indicating more aggressive disease. |
| Secondary | Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | Baseline to Week 52 | MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%) and ranges from 0 to 100% with higher values representing higher liver fat level. Least square (LS) mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Diabetes Flag (DIABFL) + REGION1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured. |
| Secondary | Mean Change From Baseline in Body Weight | Baseline to Week 52 | Change in body weight at the end of 52 weeks measured in kilogram (kg) using a calibrated scale. LS mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | Week 52 | All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology | Week 52 | All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology | Week 52 | All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Week 52 | All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation. | Percentage of participants | NUMBER |
| SECONDARY | Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | Baseline to Week 52 | All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation. | absolute percentage of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Body Weight | Baseline to Week 52 | All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation. | Kilogram (kg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | 5 mg Tirzepatide | 51.84 | Percentage of participants | ||
| Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | 10 mg Tirzepatide | 63.13 | Percentage of participants | ||
| Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | 15 mg Tirzepatide | 73.92 | Percentage of participants | ||
| Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology | Placebo | 12.62 | Percentage of participants | ||
| Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology | 5 mg Tirzepatide | 59.21 | Percentage of participants | ||
| Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology | 10 mg Tirzepatide | 53.35 | Percentage of participants | ||
| Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology | 15 mg Tirzepatide | 54.3 | Percentage of participants | ||
| Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology | Placebo | 32.51 | Percentage of participants | ||
| Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology | 5 mg Tirzepatide | 12.04 | Percentage of participants | ||
| Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology | 10 mg Tirzepatide | 9.81 | Percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5 Milligram (mg) Tirzepatide | 47 | |
| Overall Study | STARTED | 10 mg Tirzepatide | 47 | |
| Overall Study | STARTED | 15 mg Tirzepatide | 48 | |
| Overall Study | STARTED | Placebo | 48 | |
| Overall Study | Received at Least One Dose of Study Drug | 5 Milligram (mg) Tirzepatide | 47 | |
| Overall Study | Received at Least One Dose of Study Drug | 10 mg Tirzepatide | 47 | |
| Overall Study | Received at Least One Dose of Study Drug | 15 mg Tirzepatide | 48 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 48 | |
| Overall Study | COMPLETED | 5 Milligram (mg) Tirzepatide | 40 | |
| Overall Study | COMPLETED | 10 mg Tirzepatide | 44 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 5 mg Tirzepatide | 1 | 47 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | 10 mg Tirzepatide | 0 | 47 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 15 mg Tirzepatide | 0 | 48 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 48 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | 5 mg Tirzepatide | 1 | 47 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | 10 mg Tirzepatide | 0 | 47 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | 15 mg Tirzepatide | 0 | 48 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 48 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 5 mg Tirzepatide | 0 | 47 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 10 mg Tirzepatide | 0 | 47 | 0 |
1 to 10 of 1,168Source ClinicalTrials.gov
See all 1,168 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5 mg Tirzepatide | 0 | 47 |
| Total, all-cause mortality | 10 mg Tirzepatide | 0 | 47 |
| Total, all-cause mortality | 15 mg Tirzepatide | 0 | 48 |
| Total, all-cause mortality | Placebo | 0 | 48 |
| Total, other adverse events | 5 mg Tirzepatide | 43 | 47 |
| Total, other adverse events | 10 mg Tirzepatide | 43 | 47 |
| Total, other adverse events | 15 mg Tirzepatide | 44 | 48 |
| Total, other adverse events | Placebo | 40 | 48 |
| Total, serious adverse events | 5 mg Tirzepatide | 5 | 47 |
| Total, serious adverse events | 10 mg Tirzepatide | 4 | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38856224 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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