Trial · NCT03467217

Losartan for the Treatment of Pediatric NAFLD

NCT03467217, Phase 2, Terminated, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2021-10-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Losartan for the Treatment of Pediatric NAFLD. Trials, record NCT03467217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03467217

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Losartan for the Treatment of Pediatric NAFLD
NCT number: NCT03467217
Status: Terminated
Phases: Phase 2
Enrollment: 83 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: NAFLD - Nonalcoholic Fatty Liver Disease
Interventions: Losartan potassium, Placebo losartan capsule
First posted: 2018-03-15
Last updated: 2021-10-21
Results first posted: 2021-10-21

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Serum Alanine Aminotransferase (ALT) From Baseline.	Baseline and 24 weeks	Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement.
Secondary	Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline	Baseline and 24 weeks	Change from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L.
Secondary	Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST	Baseline and 24 weeks	Change from baseline in serum aspartate aminotransferase, measured in U/L.
Secondary	Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT	Baseline and 24 weeks	Relative change from baseline in serum ALT, measured in percentage of change.
Secondary	Change in ALT at 12 Weeks Compared to Baseline ALT	Baseline and 12 weeks	Change from baseline in ALT at 12 weeks, measured in U/L.
Secondary	Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.	Baseline and 24 weeks	Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Secondary	Change in Weight at 24 Weeks Compared to Baseline	Baseline and 24 weeks	Change from baseline in weight, measured in kg.
Secondary	Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.	Baseline and 24 weeks	Change from baseline in BMI, measured in kg/m\^2.
Secondary	Change in Waist Circumference at 24 Weeks Compared to Baseline	Baseline and 24 weeks	Change from baseline in waist circumference, measured in centimeters.
Secondary	Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline	Baseline and 24 weeks	Change from baseline in waist-to-hip ratio, measured as the circumference of the waist in centimeters divided by the circumference of the hips in centimeters.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Serum Alanine Aminotransferase (ALT) From Baseline.	Baseline and 24 weeks	Results based on complete case analysis.	U/L	MEAN
SECONDARY	Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline	Baseline and 24 weeks		U/L	MEAN
SECONDARY	Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST	Baseline and 24 weeks		U/L	MEAN
SECONDARY	Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT	Baseline and 24 weeks		percentage of change	MEAN
SECONDARY	Change in ALT at 12 Weeks Compared to Baseline ALT	Baseline and 12 weeks		mg/dL	MEAN
SECONDARY	Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.	Baseline and 24 weeks		mg/dL x uU/mL/405	MEAN
SECONDARY	Change in Weight at 24 Weeks Compared to Baseline	Baseline and 24 weeks		kg	MEAN
SECONDARY	Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.	Baseline and 24 weeks		kg/m^2	MEAN
SECONDARY	Change in Waist Circumference at 24 Weeks Compared to Baseline	Baseline and 24 weeks		cm	MEAN
SECONDARY	Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline	Baseline and 24 weeks		ratio	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Serum Alanine Aminotransferase (ALT) From Baseline.	Losartan Potassium Capsule	-5.3	Standard Deviation 51.4	U/L
Change in Serum Alanine Aminotransferase (ALT) From Baseline.	Placebo Losartan Capsule	-6.3	Standard Deviation 77.5	U/L
Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline	Losartan Potassium Capsule	-1.9	Standard Deviation 13.9	U/L
Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline	Placebo Losartan Capsule	0.6	Standard Deviation 19.7	U/L
Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST	Losartan Potassium Capsule	0.2	Standard Deviation 27.2	U/L
Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST	Placebo Losartan Capsule	-4.5	Standard Deviation 37.0	U/L
Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT	Losartan Potassium Capsule	2.7	Standard Deviation 43.8	percentage of change
Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT	Placebo Losartan Capsule	-5.7	Standard Deviation 73.2	percentage of change
Change in ALT at 12 Weeks Compared to Baseline ALT	Losartan Potassium Capsule	-5.8	Standard Deviation 43.0	mg/dL
Change in ALT at 12 Weeks Compared to Baseline ALT	Placebo Losartan Capsule	-19.3	Standard Deviation 38.5	mg/dL

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Losartan	43
Overall Study	STARTED	Placebo	40
Overall Study	COMPLETED	Losartan	33
Overall Study	COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	Losartan	10
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events74

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	Losartan	2	43	2
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	40	1
other	Back pain	Musculoskeletal and connective tissue disorders	Losartan	1	43	1
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	1	40	1
other	Conjunctivitis	Infections and infestations	Losartan	0	43	0
other	Conjunctivitis	Infections and infestations	Placebo	1	40	1
other	Cough	Respiratory, thoracic and mediastinal disorders	Losartan	1	43	1
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	1	40	1
other	Diarrhea	Gastrointestinal disorders	Losartan	2	43	2
other	Diarrhea	Gastrointestinal disorders	Placebo	2	40	2

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Losartan	0	43
Total, all-cause mortality	Placebo	0	40
Total, other adverse events	Losartan	28	43
Total, other adverse events	Placebo	25	40
Total, serious adverse events	Losartan	0	43
Total, serious adverse events	Placebo	4	40

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40434633	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK061730	Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network	TONASCIA, JAMES A	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2002 to 2018

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Losartan vs Placebo: deaths from any cause	Trial comparisons
Losartan vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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