Trial · NCT04216589
Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
NCT04216589, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2024-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study). Trials, record NCT04216589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04216589
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
- NCT number
- NCT04216589
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections, Non-Alcoholic Fatty Liver Disease
- Interventions
- Semaglutide
- First posted
- 2020-01-02
- Last updated
- 2024-10-01
- Results first posted
- 2024-05-17
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change (Absolute) in IHTG (%) | Measured at pre-entry and Week 24 | The absolute change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit. |
| Secondary | Change (Percent) in IHTG (%) | Measured at pre-entry and Week 24 | The percentage change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit. The percentage change is defined as IHTC % at week 24 minus IHTC % at pre-entry, then divided by IHTC % at pre-entry, then multiplied by 100. |
| Secondary | Level of IHTG (%) | Measured at Week 24 | Intra-hepatic triglyceride content (%) at Week 24 (\<5% vs. \>=5%). All participants were \>=5% at pre-entry. |
| Secondary | Occurrence of Premature Discontinuation of Study Treatment | Measured through Week 24 | Premature study treatment discontinuation prior to the Week 24 visit. |
| Secondary | Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment | Measured through Week 24 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. |
| Secondary | Change (Absolute) in Body Mass Index (BMI) | Measured at Week 0 and Week 24 | The absolute change in body mass index from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Body Mass Index (BMI) | Measured from Week 0 to Week 12 | The absolute change in body mass index from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Body Weight | Measured at Week 0 and Week 24 | The absolute change in body weight from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Body Weight | Measured at Week 0 and Week 12 | The absolute change in body weight from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Minimum Waist Circumference (WC) | Measured at Week 0 and Week 24 | The absolute change in minimum WC from the study entry (Week 0) visit to the Week 24 visit. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change (Absolute) in IHTG (%) | Measured at pre-entry and Week 24 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | IHTG % | MEAN |
| SECONDARY | Change (Percent) in IHTG (%) | Measured at pre-entry and Week 24 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | Relative change % | MEAN |
| SECONDARY | Level of IHTG (%) | Measured at Week 24 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | participants | NUMBER |
| SECONDARY | Occurrence of Premature Discontinuation of Study Treatment | Measured through Week 24 | Analysis was done in the intent-to-treat population. These were all participants who were enrolled to the study. | participants | NUMBER |
| SECONDARY | Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment | Measured through Week 24 | Analysis was done in the intent-to-treat population. These were all participants who were enrolled to the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change (Absolute) in Body Mass Index (BMI) | Measured at Week 0 and Week 24 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | kg/m^2 | MEAN |
| SECONDARY | Change (Absolute) in Body Mass Index (BMI) | Measured from Week 0 to Week 12 | Per-protocol population (N=49) | kg/m^2 | MEAN |
| SECONDARY | Change (Absolute) in Body Weight | Measured at Week 0 and Week 24 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | kg | MEAN |
| SECONDARY | Change (Absolute) in Body Weight | Measured at Week 0 and Week 12 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | kg | MEAN |
| SECONDARY | Change (Absolute) in Minimum Waist Circumference (WC) | Measured at Week 0 and Week 24 | Analysis was done in the per-protocol population. These were all participants who remained on study treatment until 28 days prior to the Week 24 MRI and who did not start prohibited medications known to cause changes in weight prior to the Week 24 MRI. | cm | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change (Absolute) in IHTG (%) | Semaglutide | -4.24 | 95% Confidence Interval -5.41 to -3.06 | IHTG % | |
| Change (Percent) in IHTG (%) | Semaglutide | -31.33 | 95% Confidence Interval -39.04 to -23.62 | Relative change % | |
| Level of IHTG (%) | Semaglutide | <5% IHTG | 14 | participants | |
| Level of IHTG (%) | Semaglutide | >=5% IHTG | 34 | participants | |
| Occurrence of Premature Discontinuation of Study Treatment | Semaglutide | Premature discontinuation | 3 | participants | |
| Occurrence of Premature Discontinuation of Study Treatment | Semaglutide | Completed study treatment | 48 | participants | |
| Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment | Semaglutide | Yes | 2 | Participants | |
| Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment | Semaglutide | No | 49 | Participants | |
| Change (Absolute) in Body Mass Index (BMI) | Semaglutide | -2.77 | 95% Confidence Interval -3.36 to -2.17 | kg/m^2 | |
| Change (Absolute) in Body Mass Index (BMI) | Semaglutide | -2.15 | 95% Confidence Interval -2.55 to -1.75 | kg/m^2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide | 51 | |
| Overall Study | Completed Study Treatment | Semaglutide | 48 | |
| Overall Study | COMPLETED | Semaglutide | 47 | |
| Overall Study | NOT COMPLETED | Semaglutide | 4 |
Source ClinicalTrials.gov
Adverse events25
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 | Abdominal pain | Gastrointestinal disorders | Semaglutide | 1 | 51 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Semaglutide | 1 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | Semaglutide | 1 | 51 | |
| other | Dyspepsia | Gastrointestinal disorders | Semaglutide | 1 | 51 | |
| other | Flatulence | Gastrointestinal disorders | Semaglutide | 1 | 51 | |
| other | Nausea | Gastrointestinal disorders | Semaglutide | 3 | 51 | |
| other | Vomiting | Gastrointestinal disorders | Semaglutide | 2 | 51 | |
| other | Chills | General disorders | Semaglutide | 1 | 51 | |
| other | Fatigue | General disorders | Semaglutide | 1 | 51 | |
| other | Blood cholesterol increased | Investigations | Semaglutide | 1 | 51 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide | 0 | 51 |
| Total, other adverse events | Semaglutide | 20 | 51 |
| Total, serious adverse events | Semaglutide | 2 | 51 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT04216589
GET https://conductscience.org/api/trials/v1/NCT04216589/registered?page=2