Trial · NCT05364684
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NCT05364684, Phase 2, Completed, Massachusetts General Hospital; results first posted 2026-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease. Trials, record NCT05364684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05364684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
- NCT number
- NCT05364684
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Interventions
- LUM-201
- First posted
- 2022-05-06
- Last updated
- 2026-01-06
- Results first posted
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intrahepatic Lipid Content (IHL, Percent Liver Fat) | 6 Months | Change in intrahepatic lipid content (6-month percent liver fat minus baseline percent liver fat) as measured by proton magnetic resonance spectroscopy (1H-MRS). Outcome is presented as change in percent liver fat. |
| Secondary | Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score | 6 Months | Change in hepatic inflammation and fibrosis by LiverMultiScan cT1 (6-month cT1 score minus baseline cT1 score). Outcome is presented as change in cT1 score (ms). Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms). |
| Secondary | Alanine Aminotransferase (ALT) | 6 Months | Change in ALT (6-month ALT minus baseline ALT). Outcome is presented as change in ALT (U/L). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intrahepatic Lipid Content (IHL, Percent Liver Fat) | 6 Months | absolute change in percentage liver fat | MEAN | |
| SECONDARY | Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score | 6 Months | ms | MEAN | |
| SECONDARY | Alanine Aminotransferase (ALT) | 6 Months | U/L | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intrahepatic Lipid Content (IHL, Percent Liver Fat) | Open-label Treatment With Ibutamoren | 3.9 | Standard Deviation 6.7 | absolute change in percentage liver fat | |
| Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score | Open-label Treatment With Ibutamoren | 39 | Standard Deviation 44 | ms | |
| Alanine Aminotransferase (ALT) | Open-label Treatment With Ibutamoren | 8 | Standard Deviation 18 | U/L |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open-label Treatment | 12 | |
| Overall Study | COMPLETED | Open-label Treatment | 7 | |
| Overall Study | NOT COMPLETED | Open-label Treatment | 5 |
Source ClinicalTrials.gov
Adverse events29
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 | Blurry vision | Eye disorders | Open-label Treatment | 1 | 12 | |
| other | Gastroenteritis | Gastrointestinal disorders | Open-label Treatment | 1 | 12 | |
| other | Diarrhea | Gastrointestinal disorders | Open-label Treatment | 2 | 12 | |
| other | Increased gas/bloating | Gastrointestinal disorders | Open-label Treatment | 2 | 12 | |
| other | Epigastric pain/GERD | Gastrointestinal disorders | Open-label Treatment | 1 | 12 | |
| other | Constipation | Gastrointestinal disorders | Open-label Treatment | 1 | 12 | |
| other | Fatigue | General disorders | Open-label Treatment | 3 | 12 | |
| other | Night sweats | General disorders | Open-label Treatment | 1 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-label Treatment | 2 | 12 | |
| other | Ear infection | Ear and labyrinth disorders | Open-label Treatment | 1 | 12 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Treatment | 0 | 12 |
| Total, other adverse events | Open-label Treatment | 12 | 12 |
| Total, serious adverse events | Open-label Treatment | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05364684
GET https://conductscience.org/api/trials/v1/NCT05364684/events?page=2