Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06768216
Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD
A study testing Indianized version of Mediterranean Diet, Low Fat Diet and Physical Activity in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent (1). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Indianized version of Mediterranean Diet, Low Fat Diet and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 8-18 years
- BMI > 85th centile
- CAP > 236
Who cannot join
- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ashray S Patel, MD, 01146300000, patel1995ash@gmail.com
About this study
Official title: Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD: A Randomized Control Trial
NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent (1). Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD (2). EASL guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss (3). Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation (4). There are various studies showing benefits of using other diets such as Low Fat Diet, Low Carbdohydrate diet, Low Fructose Diet, et. Though there are numerous studies in adults comparing Mediterranean diet vs Low Fat diet, date regarding the same in children are lacking. The aim of this study will be to compare the Effect of Indianized version of Mediterranean diet vs. Low Fat Diet on Hepatic Steatosis in Overweight children and adolescent with MASLD.
Read the detailed description
Aim: To Study the effect of Indianized version of Mediterranean diet versus Low Fat diet on Non-Invasive markers of hepatic steatosis in children and adolescent with MASLD.
Primary objective: To compare the proportions of patients achieving normal CAP values (<236db/m) after 180 days of IMD versus LFD in children and adolescent with MASLD.
Secondary objectives:
- To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
- To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
- To compare the changes in CAP value in PNPLA3 mutant children.
- To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
- To compare the changes in following parameters in both study groups: Weight, BMI, HOMA IR and Lipid profile.
- To compare the adherence to IMD, with the help of Modified KIDMED score.
- Study design: Prospective, Randomized, Single center Open label study.
- Children and adolescent aged 8 to 18 years with CAP > 236dB/m will be enrolled in the study. Consent for dietary intervention will be taken. Baseline parameters analysed includes:
- Anthropometry :
- Weight, Height, BMI, Waist circumference
- Imaging:
- Ultrasonography abdomen, Fibroscan (LSM, CAP values)
- Biochemical parameters:
- ALT, AST, Lipid profile, HOMA IR
- Adiponectin \& Cytokines: TNF alpha, IL6, IL-1β, and IL-17
- Liver Biopsy when indicated: ALT>80, LSM>8.6.
- Intervention:
Both the groups will have be given a handmade individualised (according to weight) specific diet to follow. Indo-Mediterranean diet will be given to one group and other group will have Calorie restricted diet. Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Low fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. Calories will be calculated according to the age specified RDA from ICMR guidelines. In Indo-Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour). They will be advised to eat Dairy products in moderation and if non vegetarian diet (Fish, chicken, only twice a week). Dry fruits (Walnuts) and herbs (cinnamon, garlic, basil, and pepper) will be an important part of the diet. In the Low Fat Diet group, there will be only be restriction of total fat content to less than <30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. Along with this, both groups will be given a list of do's and dont's. In the list of Do's , it will be mentioned to Eat plenty of vegetables, Fruits, Nuts, Whole grains, at least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking), Screen time of less <2 hrs /day (According to American academy of pediatrics) and Average hours of sleep in a day for age 8-18 = 8-9 hrs (According to American academy of sleep medicine). In the dont's list, it will be mentioned to avoid Sugar, Soda, Beverages, cold drinks, processed juices, processed food, junk foods, Maida, Ice cream, Creamy Desserts, Biscuit, chips and cake.
- Monitoring and assessment: All Parameters will be re-assessed at 180 days (except liver biopsy). Both groups will be explained to maintain a food diary mentioning cheat days (Food other than the diet given), screen time (<2hrs/day), Exercise (45-60 mins/day, parameters will be checked by pedometer app) and average hours of sleep (8-9hrs/day). Food diary will be checked once in two weeks on phone calls or virtual OPD. Once weekly phone calls (30 mins) will be checked to see the adherence and to motivate the child. They will be required to follow up in OPD once in a month. Adherence to Indo Mediterranean diet will be assessed by Modified KIDMED score.
- Being tested
- Indianized version of Mediterranean Diet, Low Fat Diet, Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indianized version of Mediterranean DietOther
Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour).
Low Fat DietOther
Low fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. In the Low Fat Diet group, there will be only be restriction of total fat content to less than <30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. Along with this, both groups will be given a list of do's and dont's. In the list of Do's , it will be mentioned to Eat plenty of vegetables, Fruits, Nuts, Whole grains, Screen time of less <2 hrs /day (According to American academy of pediatrics) and Average hours of sleep in a day for age 8-18 = 8-9 hrs (According to American academy of sleep medicine). In the dont's list, it will be mentioned to avoid Sugar, Soda, Beverages, cold drinks, processed juices, processed food, junk foods, Maida, Ice cream, Creamy Desserts, Biscuit, chips and cake.
Physical ActivityOther
At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking),
| Study group | Role | What they receive |
|---|---|---|
| Indianized version of Mediterranean Diet+Physical Activity | Active comparator | Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour). At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking), Receives: Other: Indianized version of Mediterranean Diet; Other: Physical Activity |
| Low Fat Diet + Physical Activity | Experimental | Low fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. In the Low Fat Diet group, there will be only be restriction of total fat content to less than <30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. Receives: Other: Low Fat Diet; Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the proportions of patients achieving normal CAP values (<236db/m) after 180 days of IMD versus LFD in children and adolescent with MASLD.
Measured: 180 days
Secondary outcomes (9)
To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
Measured: 180 days
To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
Measured: 180 days
To compare the changes in CAP value in PNPLA3 mutant children.
Measured: 180 days
To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
Measured: 180 days
To compare the changes in following parameters in both study groups: Weight.
Measured: 180 days
To compare the changes in following parameters in both study groups: BMI.
Measured: 180 days
To compare the changes in following parameters in both study groups: HOMA IR .
Measured: 180 days
To compare the changes in following parameters in both study groups: Lipid profile.
Measured: 180 days
To compare the adherence to IMD, with the help of Modified KIDMED score.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768216
- Sponsor's protocol ID
- ILBS-MASDL-01
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06768216
- Acronym / sponsor ID
- ILBS-MASDL-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent (1). Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD (2). EASL guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss (3). Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation (4). There are various studies showing benefits of using other diets such as Low Fat Diet, Low Carbdohydrate diet, Low Fructose Diet, et. Though there are numerous studies in adults comparing Mediterranean diet vs Low Fat diet, date regarding the same in children are lacking. The aim of this study will be to compare the Effect of Indianized version of Mediterranean diet vs. Low Fat Diet on Hepatic Steatosis in Overweight children and adolescent with MASLD.
Detailed description
Aim: To Study the effect of Indianized version of Mediterranean diet versus Low Fat diet on Non-Invasive markers of hepatic steatosis in children and adolescent with MASLD.
Primary objective: To compare the proportions of patients achieving normal CAP values (<236db/m) after 180 days of IMD versus LFD in children and adolescent with MASLD.
Secondary objectives:
- To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
- To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
- To compare the changes in CAP value in PNPLA3 mutant children.
- To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
- To compare the changes in following parameters in both study groups: Weight, BMI, HOMA IR and Lipid profile.
- To compare the adherence to IMD, with the help of Modified KIDMED score.
- Study design: Prospective, Randomized, Single center Open label study.
- Children and adolescent aged 8 to 18 years with CAP > 236dB/m will be enrolled in the study. Consent for dietary intervention will be taken. Baseline parameters analysed includes:
- Anthropometry :
- Weight, Height, BMI, Waist circumference
- Imaging:
- Ultrasonography abdomen, Fibroscan (LSM, CAP values)
- Biochemical parameters:
- ALT, AST, Lipid profile, HOMA IR
- Adiponectin \& Cytokines: TNF alpha, IL6, IL-1β, and IL-17
- Liver Biopsy when indicated: ALT>80, LSM>8.6.
- Intervention:
Both the groups will have be given a handmade individualised (according to weight) specific diet to follow. Indo-Mediterranean diet will be given to one group and other group will have Calorie restricted diet. Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Low fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. Calories will be calculated according to the age specified RDA from ICMR guidelines. In Indo-Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour). They will be advised to eat Dairy products in moderation and if non vegetarian diet (Fish, chicken, only twice a week). Dry fruits (Walnuts) and herbs (cinnamon, garlic, basil, and pepper) will be an important part of the diet. In the Low Fat Diet group, there will be only be restriction of total fat content to less than <30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. Along with this, both groups will be given a list of do's and dont's. In the list of Do's , it will be mentioned to Eat plenty of vegetables, Fruits, Nuts, Whole grains, at least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking), Screen time of less <2 hrs /day (According to American academy of pediatrics) and Average hours of sleep in a day for age 8-18 = 8-9 hrs (According to American academy of sleep medicine). In the dont's list, it will be mentioned to avoid Sugar, Soda, Beverages, cold drinks, processed juices, processed food, junk foods, Maida, Ice cream, Creamy Desserts, Biscuit, chips and cake.
- Monitoring and assessment: All Parameters will be re-assessed at 180 days (except liver biopsy). Both groups will be explained to maintain a food diary mentioning cheat days (Food other than the diet given), screen time (<2hrs/day), Exercise (45-60 mins/day, parameters will be checked by pedometer app) and average hours of sleep (8-9hrs/day). Food diary will be checked once in two weeks on phone calls or virtual OPD. Once weekly phone calls (30 mins) will be checked to see the adherence and to motivate the child. They will be required to follow up in OPD once in a month. Adherence to Indo Mediterranean diet will be assessed by Modified KIDMED score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indianized version of Mediterranean Diet+Physical Activity | Active comparator | Other: Indianized version of Mediterranean Diet, Other: Physical ActivityIndo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour). At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking), |
| Low Fat Diet + Physical Activity | Experimental | Other: Low Fat Diet, Other: Physical ActivityLow fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. In the Low Fat Diet group, there will be only be restriction of total fat content to less than <30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: 8-18 years
- BMI > 85th centile
- CAP > 236
Key exclusion criteria (1 listed)
- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.
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 |
|---|---|---|
| Indianized version of Mediterranean DietIndo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour). | Other | Indianized version of Mediterranean Diet+Physical Activity |
| Low Fat DietLow fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. In the Low Fat Diet group, there will be only be restriction of total fat content to less than <30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. Along with this, both groups will be given a list of do's and dont's. In the list of Do's , it will be mentioned to Eat plenty of vegetables, Fruits, Nuts, Whole grains, Screen time of less <2 hrs /day (According to American academy of pediatrics) and Average hours of sleep in a day for age 8-18 = 8-9 hrs (According to American academy of sleep medicine). In the dont's list, it will be mentioned to avoid Sugar, Soda, Beverages, cold drinks, processed juices, processed food, junk foods, Maida, Ice cream, Creamy Desserts, Biscuit, chips and cake. | Other | Low Fat Diet + Physical Activity |
| Physical ActivityAt least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking), | Other | Indianized version of Mediterranean Diet+Physical Activity, Low Fat Diet + Physical Activity |
Primary outcome
To compare the proportions of patients achieving normal CAP values (<236db/m) after 180 days of IMD versus LFD in children and adolescent with MASLD.
Time frame: 180 days
9 secondary outcomes
To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
Time frame: 180 days
To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
Time frame: 180 days
To compare the changes in CAP value in PNPLA3 mutant children.
Time frame: 180 days
To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
Time frame: 180 days
To compare the changes in following parameters in both study groups: Weight.
Time frame: 180 days
To compare the changes in following parameters in both study groups: BMI.
Time frame: 180 days
To compare the changes in following parameters in both study groups: HOMA IR .
Time frame: 180 days
To compare the changes in following parameters in both study groups: Lipid profile.
Time frame: 180 days
To compare the adherence to IMD, with the help of Modified KIDMED score.
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indianized version of Mediterranean Diet, Low Fat Diet and Physical Activity in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ashray S Patel, MD (01146300000, patel1995ash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the proportions of patients achieving normal CAP values (<236db/m) after 180 days of IMD versus LFD in children and adolescent with MASLD. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.