NAFLD - Nonalcoholic Fatty Liver DiseasePhase 2STOP-NAFLDNCT03467217
Losartan for the Treatment of Pediatric NAFLD
A Phase 2 study testing Losartan potassium in people with NAFLD - Nonalcoholic Fatty Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 10 sites in United States.
Trial summary
A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- NAFLD - Nonalcoholic Fatty Liver Disease
- What is being tested?
- Losartan potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Oct 2018to 30 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-17 years at initial screening interview
- Histological evidence of NAFLD with or without fibrosis and a NAFLD activity score (NAS) of ≥3, on a liver biopsy obtained no more than 730 days prior to enrollment.
- Serum ALT at screening ≥ 50 IU/L
Who cannot join
- Body weight less than 70 kg or greater than 150 kg at screening
- Significant alcohol consumption or inability to reliably quantify alcohol intake
- Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 consecutive weeks in the past year prior to randomization
- New treatment with vitamin E or metformin started in the past 90 days or plans to alter the dose or stop over the next the 24 weeks. A stable dose is acceptable.
- Prior or planned bariatric surgery
- Uncontrolled diabetes (HbA1c 9.5% or higher)
Show all 34Show fewer
- Presence of cirrhosis on liver biopsy
- History of hypotension or history of orthostatic hypotension
- Stage 2 Hypertension or >140 systolic or >90 diastolic at screening
- Current treatment with any antihypertensive medications including all angiotensin converting enzyme (ACE) inhibitors or aliskiren
- Current treatment with potassium supplements or any drug known to increase potassium
- Current daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Current treatment with lithium
- Platelet counts below 100,000 /mm3
- Clinical evidence of hepatic decompensation (serum albumin < 3.2 g/dL, international normalized ratio (INR) >1.3, direct bilirubin >1.3 mg/dL, history of esophageal varices, ascites, or hepatic encephalopathy)
- Evidence of chronic liver disease other than NAFLD:
- Biopsy consistent with histological evidence of autoimmune hepatitis
- Serum hepatitis B surface antigen (HBsAg) positive.
- Serum hepatitis C antibody (anti-HCV) positive.
- Iron/total iron binding capacity (TIBC) ratio (transferrin saturation) > 45% with histological evidence of iron overload
- Alpha-1-antitrypsin (A1AT) phenotype/genotype ZZ or SZ
- Wilson's disease
- Serum alanine aminotransferase (ALT) greater than 300 IU/L
- History of biliary diversion
- History of kidney disease and/or estimated glomerular filtration rate (eGFR) < than 60 mL/min/1.73 m2 using Schwartz Bedside GFR Calculator for Children isotope dilution mass spectroscopy (IDMS)-traceable
- Known Human Immunodeficiency Virus (HIV) infection
- Active, serious medical disease with life expectancy less than 5 years
- Active substance abuse including inhaled or injected drugs, in the year prior to screening
- Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
- Participation in an investigational new drug (IND) trial in the 150 days prior to randomization
- Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
- Inability to swallow capsules
- Known allergy to losartan potassium or other angiotensin receptor blocker
- Failure of parent or legal guardian to give informed consent or subject to give informed assent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University
Atlanta, Georgia, 30322
Northwestern Univ-Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Texas Children's Hospital
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Columbia University
New York, New York, 10032
University of California, San Diego
San Diego, California, 92103
University of California, San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195
St. Louis University
St Louis, Missouri, 63104
About this study
Official title: Losartan for the Treatment of Pediatric NAFLD (STOP-NAFLD): A Phase 2, Randomized, Placebo-Controlled Clinical Trial
A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
Read the detailed description
Children ages 8-17 years weighing between 70 -149 kilograms will be enrolled and treated with losartan (100 mg orally once per day) or matching placebo for 24 weeks. The hypothesis is that losartan will improve serum alanine aminotransferase (ALT) in children with pediatric NAFLD.
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- Being tested
- Losartan potassium, Placebo losartan capsule
- Keywords
- Losartan, Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan potassiumDrug
Also called losartan, Cozaar,
Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
Placebo losartan capsuleDrug
Matching placebo losartan oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Losartan potassium capsule | Active comparator | Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to <150 kg. Receives: Drug: Losartan potassium |
| Placebo losartan capsule | Placebo comparator | Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to <150 kg. Receives: Drug: Placebo losartan capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Alanine Aminotransferase (ALT) From Baseline.
Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement.
Measured: Baseline and 24 weeks
Secondary outcomes (16)
Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline
Change from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L.
Measured: Baseline and 24 weeks
Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST
Change from baseline in serum aspartate aminotransferase, measured in U/L.
Measured: Baseline and 24 weeks
Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT
Relative change from baseline in serum ALT, measured in percentage of change.
Measured: Baseline and 24 weeks
Change in ALT at 12 Weeks Compared to Baseline ALT
Change from baseline in ALT at 12 weeks, measured in U/L.
Measured: Baseline and 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.
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.
Measured: Baseline and 24 weeks
Change in Weight at 24 Weeks Compared to Baseline
Change from baseline in weight, measured in kg.
Measured: Baseline and 24 weeks
Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.
Change from baseline in BMI, measured in kg/m^2.
Measured: Baseline and 24 weeks
Change in Waist Circumference at 24 Weeks Compared to Baseline
Change from baseline in waist circumference, measured in centimeters.
Measured: Baseline and 24 weeks
Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline
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.
Measured: Baseline and 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline
Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. The outcome is 24-week change from baseline in PedsQOL Physical Health Score, where higher values indicate improvement in quality of life.
Measured: Baseline and 24 weeks
Frequency of Adverse Events Over 24 Weeks
Numbers of adverse events reported over 24 weeks.
Measured: Baseline and 24 weeks
Change in Total Cholesterol at 24 Weeks Compared to Baseline
Change from baseline in total cholesterol, measured in mg/dL
Measured: Baseline and 24 weeks
Change in Triglycerides at 24 Weeks Compared to Baseline
Change from baseline in triglycerides, measured in mg/dL
Measured: Baseline and 24 weeks
Change in HDL Cholesterol at 24 Weeks Compared to Baseline
Change from baseline in HDL cholesterol, measured in mg/dL
Measured: Baseline and 24 weeks
Change in LDL Cholesterol at 24 Weeks Compared to Baseline
Change from baseline in LDL cholesterol, measured in mg/dL
Measured: Baseline and 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline
Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales. The outcome is 24-week change from baseline in PedsQOL Psychosocial Health Score, where higher values indicate improvement in quality of life.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start2 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Trial stopped for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLD - Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Edward Doo, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467217
- Sponsor's protocol ID
- 9 STOP-NAFLD
- Other IDs
- U01DK061730
- Acronym
- STOP-NAFLD
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2018
- Last updated
- 21 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Results information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository.
Publications
Hakim A, Lin KH, Schwantes-An TH, Abreu M, Tan J, Guo X, Yates KP, Lotta L, Verweij N, Loomba R, Kleiner DE, Schwimmer JB, Rotter JI, Chalasani NP. A comprehensive evaluation of candidate genetic polymorphisms in a large histologically characterized MASLD cohort using a novel framework. Hepatol Commun. 2025 May 29;9(6):e0728. doi: 10.1097/HC9.0000000000000728. eCollection 2025 Jun 1.
PubMed 40434633
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losartan for the Treatment of Pediatric NAFLD (STOP-NAFLD): A Phase 2, Randomized, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03467217
- Acronym / sponsor ID
- STOP-NAFLD / 9 STOP-NAFLD
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease
- Keywords
- Losartan, Nonalcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial stopped for futility
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Johns Hopkins University
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Posted 21 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
Detailed description
Children ages 8-17 years weighing between 70 -149 kilograms will be enrolled and treated with losartan (100 mg orally once per day) or matching placebo for 24 weeks. The hypothesis is that losartan will improve serum alanine aminotransferase (ALT) in children with pediatric NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan potassium capsule | Active comparator | Drug: Losartan potassiumDose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to <150 kg. |
| Placebo losartan capsule | Placebo comparator | Drug: Placebo losartan capsuleDose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to <150 kg. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 8-17 years at initial screening interview
- Histological evidence of NAFLD with or without fibrosis and a NAFLD activity score (NAS) of ≥3, on a liver biopsy obtained no more than 730 days prior to enrollment.
- Serum ALT at screening ≥ 50 IU/L
Key exclusion criteria (34 listed)
- Body weight less than 70 kg or greater than 150 kg at screening
- Significant alcohol consumption or inability to reliably quantify alcohol intake
- Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 consecutive weeks in the past year prior to randomization
- New treatment with vitamin E or metformin started in the past 90 days or plans to alter the dose or stop over the next the 24 weeks. A stable dose is acceptable.
- Prior or planned bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Losartan potassiumAlso: losartan, Cozaar,Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype | Drug | Losartan potassium capsule |
| Placebo losartan capsuleMatching placebo losartan oral capsule | Drug | Placebo losartan capsule |
Primary outcome
Change in Serum Alanine Aminotransferase (ALT) From Baseline.
Time frame: Baseline and 24 weeks
Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement.
16 secondary outcomes
Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline
Time frame: Baseline and 24 weeks
Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST
Time frame: Baseline and 24 weeks
Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT
Time frame: Baseline and 24 weeks
Change in ALT at 12 Weeks Compared to Baseline ALT
Time frame: Baseline and 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.
Time frame: Baseline and 24 weeks
Change in Weight at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.
Time frame: Baseline and 24 weeks
Change in Waist Circumference at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Frequency of Adverse Events Over 24 Weeks
Time frame: Baseline and 24 weeks
Change in Total Cholesterol at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in Triglycerides at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in HDL Cholesterol at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in LDL Cholesterol at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40434633Hakim A, Lin KH, Schwantes-An TH, Abreu M, Tan J, Guo X, Yates KP, Lotta L, Verweij N, Loomba R, Kleiner DE, Schwimmer JB, Rotter JI, Chalasani NP. A comprehensive evaluation of candidate genetic polymorphisms in a large histologically characterized MASLD cohort using a novel framework. Hepatol Commun. 2025 May 29;9(6):e0728. doi: 10.1097/HC9.0000000000000728. eCollection 2025 Jun 1.
- Nonalcoholic Steatohepatitis Clinical Research Network CentersLink provided by the sponsor.
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Results information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Doo, MD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Losartan potassium in people with NAFLD - Nonalcoholic Fatty Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Alanine Aminotransferase (ALT) From Baseline. (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.