Trial · NCT01431521
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
NCT01431521, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2016-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008). Trials, record NCT01431521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01431521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
- NCT number
- NCT01431521
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- MK-4074 200 mg, Placebo for MK-4074, Pioglitazone hydrochloride 30 mg, Placebo for pioglitazone hydrochloride
- First posted
- 2011-09-09
- Last updated
- 2018-09-10
- Results first posted
- 2016-03-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Hepatic Fat | Baseline and Week 4 | Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant. |
| Primary | Number of Participants Experiencing One or More Adverse Events (AE) | Up to 10 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Primary | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 4 weeks | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Percent Change From Baseline in Alanine Transaminase (ALT) | Baseline and Week 4 | Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, specifically ALT, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study. |
| Secondary | Percent Change From Baseline Aspartate Transaminase (AST) | Baseline and Week 4 | Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, including AST, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Hepatic Fat | Baseline and Week 4 | Per-Protocol (PP) Population consists of those participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Alanine Transaminase (ALT) | Baseline and Week 4 | The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have ALT data for Day 28. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Aspartate Transaminase (AST) | Baseline and Week 4 | The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have AST data for Day 28. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants Experiencing One or More Adverse Events (AE) | Up to 10 weeks | All Subjects as Treated (AST) Population consists of all participants who received at least one dose of the study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 4 weeks | The AST Population consists of all participants who received at least one dose of the study drug. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Hepatic Fat | MK-4074 | -35.73 | 95% Confidence Interval -44.53 to -26.93 | Percent change | |
| Percent Change From Baseline in Hepatic Fat | Pioglitazone | -18.04 | 95% Confidence Interval -26.84 to -9.24 | Percent change | |
| Percent Change From Baseline in Hepatic Fat | Placebo | 8.63 | 95% Confidence Interval -0.17 to 17.43 | Percent change | |
| Percent Change From Baseline in Alanine Transaminase (ALT) | MK-4074 | -9.82 | 95% Confidence Interval -21.13 to 1.49 | Percent change | |
| Percent Change From Baseline in Alanine Transaminase (ALT) | Pioglitazone | -20.21 | 95% Confidence Interval -31.52 to -8.90 | Percent change | |
| Percent Change From Baseline in Alanine Transaminase (ALT) | Placebo | -3.47 | 95% Confidence Interval -15.08 to 8.13 | Percent change | |
| Percent Change From Baseline Aspartate Transaminase (AST) | MK-4074 | -6.74 | 95% Confidence Interval -19.73 to 6.24 | Percent change | |
| Percent Change From Baseline Aspartate Transaminase (AST) | Pioglitazone | -13.95 | 95% Confidence Interval -26.93 to -0.97 | Percent change | |
| Percent Change From Baseline Aspartate Transaminase (AST) | Placebo | -3.28 | 95% Confidence Interval -16.64 to 10.08 | Percent change | |
| Number of Participants Experiencing One or More Adverse Events (AE) | MK-4074 | 4 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-4074 | 10 | |
| Overall Study | STARTED | Placebo for MK-4074 | 5 | |
| Overall Study | STARTED | Pioglitazone | 11 | |
| Overall Study | STARTED | Placebo for Pioglitazone | 5 | |
| Overall Study | Treated | MK-4074 | 10 | |
| Overall Study | Treated | Placebo for MK-4074 | 5 | |
| Overall Study | Treated | Pioglitazone | 10 | |
| Overall Study | Treated | Placebo for Pioglitazone | 5 | |
| Overall Study | COMPLETED | MK-4074 | 10 | |
| Overall Study | COMPLETED | Placebo for MK-4074 | 5 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events72
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 | Upper respiratory tract infection | Infections and infestations | MK-4074 | 2 | 10 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo for MK-4074 | 0 | 5 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Pioglitazone | 0 | 10 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo for Pioglitazone | 1 | 5 | 1 |
| other | Accidental overdose | Injury, poisoning and procedural complications | MK-4074 | 0 | 10 | 0 |
| other | Accidental overdose | Injury, poisoning and procedural complications | Placebo for MK-4074 | 0 | 5 | 0 |
| other | Accidental overdose | Injury, poisoning and procedural complications | Pioglitazone | 0 | 10 | 0 |
| other | Accidental overdose | Injury, poisoning and procedural complications | Placebo for Pioglitazone | 1 | 5 | 1 |
| other | Burns first degree | Injury, poisoning and procedural complications | MK-4074 | 1 | 10 | 1 |
| other | Burns first degree | Injury, poisoning and procedural complications | Placebo for MK-4074 | 0 | 5 | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-4074 | ||
| Total, all-cause mortality | Placebo for MK-4074 | ||
| Total, all-cause mortality | Pioglitazone | ||
| Total, all-cause mortality | Placebo for Pioglitazone | ||
| Total, other adverse events | MK-4074 | 4 | 10 |
| Total, other adverse events | Placebo for MK-4074 | 1 | 5 |
| Total, other adverse events | Pioglitazone | 4 | 10 |
| Total, other adverse events | Placebo for Pioglitazone | 4 | 5 |
| Total, serious adverse events | MK-4074 | 0 | 10 |
| Total, serious adverse events | Placebo for MK-4074 | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01431521
GET https://conductscience.org/api/trials/v1/NCT01431521/events?page=2