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)
CompletedPhase 2Results postedLast updated 1 October 2024
What this trial tests
Phase 2 trial testing Semaglutide in HIV Infections in 51 participants. Completed in 15 September 2023.
Timeline
19 February 2021
Primary endpoint 16 March 2023
15 September 2023
Quick facts
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
18 and older, any sex, with HIV Infections or Non-Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change (Absolute) in IHTG (%)Primary· 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.
Group
Value
95% CI
Semaglutide
-4.24
-5.41 – -3.06
Change (Percent) in IHTG (%)Secondary· 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.
Group
Value
95% CI
Semaglutide
-31.33
-39.04 – -23.62
Level of IHTG (%)Secondary· Measured at Week 24
Intra-hepatic triglyceride content (%) at Week 24 (\<5% vs. \>=5%). All participants were \>=5% at pre-entry.
<5% IHTG
Group
Value
95% CI
Semaglutide
14
>=5% IHTG
Group
Value
95% CI
Semaglutide
34
Occurrence of Premature Discontinuation of Study TreatmentSecondary· Measured through Week 24
Premature study treatment discontinuation prior to the Week 24 visit.
Premature discontinuation
Group
Value
95% CI
Semaglutide
3
Completed study treatment
Group
Value
95% CI
Semaglutide
48
Occurrence of Grade ≥3 Adverse Event That is Related to Study TreatmentSecondary· 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.
Group
Value
95% CI
Semaglutide
2
Semaglutide
49
Change (Absolute) in Body Mass Index (BMI)Secondary· 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.
Group
Value
95% CI
Semaglutide
-2.77
-3.36 – -2.17
Change (Absolute) in Body Mass Index (BMI)Secondary· 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.
Group
Value
95% CI
Semaglutide
-2.15
-2.55 – -1.75
Change (Absolute) in Body WeightSecondary· 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.
Group
Value
95% CI
Semaglutide
-7.80
-9.48 – -6.13
Change (Absolute) in Body WeightSecondary· 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.
Group
Value
95% CI
Semaglutide
-6.16
-7.30 – -5.03
Change (Absolute) in Minimum Waist Circumference (WC)Secondary· 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.
Group
Value
95% CI
Semaglutide
-6.66
-8.54 – -4.78
Change (Absolute) in Minimum Waist Circumference (WC)Secondary· Measured at Week 0 and Week 12
The absolute change in minimum WC from the study entry (Week 0) visit to the Week 12 visit.
Group
Value
95% CI
Semaglutide
-5.53
-7.07 – -3.99
Change (Absolute) in Insulin Resistance (HOMA-IR)Secondary· Measured at Week 0 and Week 24
The absolute change in HOMA-IR from the study entry (Week 0) visit to the Week 24 visit.
HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a method used to estimate how well your body responds to insulin.
HOMA-IR is caluclated with the following formula:
(fasting glucose in mmol/L x fasting insulin in mIU/mL)/22.5
A higher HOMA-IR score indicates a greater likelihood of insulin resistance.
Group
Value
95% CI
Semaglutide
-1.46
-3.17 – 0.25
Adverse events — posted to ClinicalTrials.gov
Time frame: From study entry to study completion at Week 48 or premature study discontinuation..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Semaglutide
Serious: 2/51 (4%)
Deaths: 0/51
Serious adverse events (2 terms)
Reaction
System
Semaglutide
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study was to evaluate the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT06977438 — Promoting Healthy Children and Youth
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NCT07218354 — Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial
· Phase 3
· not yet recruiting
NCT07511543 — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
· Phase 2
· not yet recruiting
NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
· NA
· not yet recruiting
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
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NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention
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NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad
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· recruiting
Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV
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· not yet recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS)
· Phase 1
· not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of
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NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04216589.