Non-Alcoholic Fatty Liver DiseaseNCT06348628
Motivational Interviewing in the Management of Non Alcoholic Fatty Liver Disease
A study testing Motivational Interview in people with Non-Alcoholic Fatty Liver Disease, run by Madunil Anuk Niriella at 1 site in Sri Lanka.
Trial summary
The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteSri Lanka
- Study dates
- 31 May 2022to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 years to 60 years
- Body Mass Index (BMI) is 25 kg/m^2 or more
- Newly diagnosed with NAFLD based on clinical history, ultrasound scan and laboratory values
Who cannot join
- Any medical condition that will significantly alter the weight eg: hypothyroidism, hyperthyroidism, Cushing disease
- Having moderate/severe depressive disorders or psychotic symptoms and or substance use disorders that would reduce their capacity to give consent and engage in Motivational interview
- Who are on drugs which will affect weight or mood/affect (eg: corticosteroids)
- Pregnancy or expecting to be conceive within the study period
- Having any health conditions that would impede engagement in physical activities
- Having any health conditions that would compromise the ability to follow the recommended dietary behaviors
- Concurrent involvement in another weight loss programme
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
Faculty of Medicine, University of Kelaniya
Ragama, Western Province, 11010
About this study
Official title: Motivational Interviewing for Weight Loss in the Management of Non Alcoholic Fatty Liver Disease - A Randomized Controlled Trial
The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD).
Read the detailed description
Participants with NAFLD who meet inclusion and exclusion criteria and who give informed written consent, will be randomly assigned to the intervention and control group. Randomization will be done by using a random sequence generator with concealed allocation.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Motivational Interview, Placebo
- Keywords
- Motivational Interview, Randomized Controlled Trial
- 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.
Motivational InterviewBehavioural
4 Motivational interviews within first 6 months
PlaceboBehavioural
Advices on standard of care treatment of NAFLD within first 6 months
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview with Placebo | Experimental | Each participant receives a motivational interview session at the recruitment, 1, 3, 6 months.
Simultaneously, They receive dietary, exercise and lifestyle advices. Receives: Behavioral: Motivational Interview; Behavioral: Placebo |
| Placebo | Placebo comparator | Participants receive dietary, exercise and lifestyle advices at the recruitment, 1, 3 and 6 months Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight after 1 year compared to baseline
Weight is measured using a digital scale
Measured: Baseline, 3 months, 6 months, 12 months
Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline
Lower AST and ALT levels have a better outcome
Measured: Baseline and 12 months
Change in platelet count after 1 year compared to baseline
Lower platelet count has a poor outcome
Measured: Baseline and 12 months
Change in waist circumference and hip circumference after 1 year compared to baseline
The waist circumference is measured at the narrowest part of the waist. The hip circumference is measured at the widest part of the hips. Both are measured by using a measuring tape.
Measured: Baseline and 12 months
Change in total fat percentage and visceral fat percentage after 1 year compared to baseline
Both are measured by impedance method.
Measured: Baseline and 12 months
Secondary outcomes (3)
Change in motivation for weight loss after 1 year compared to baseline
It is assessed using the validated self-report University of Rhode Island Change Assessment (URICA) scale. The minimum value is -2 and the maximum value is +14. a higher score means a better outcome while a lower score means a poor outcome.
Measured: Baseline, 12 months
Change in depression, anxiety and stress after 1 year compared to baseline
It is assessed using the Depression, Anxiety and Stress Scale-21 (DASS-21). The minimum value for depression is 0 while maximum value is 28. A score more than 21 means severe depression. A minimum value for anxiety is 0 while maximum value is 20. A score more than 15 means severe anxiety. A minimum value for stress is 0 while maximum value is 34. A score more than 26 means severe stress.
Measured: Baseline, 12 months
Change in quality of life after 1 year compared to baseline
It is assessed using the World Health Organization Quality of Life Brief (WHOQOL-BREF) version. The minimum value is 0 and the maximum value is 100. A lower score indicates poor quality of life while a higher score indicates a good quality of life.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start31 May 2022
- Primary completion22 Apr 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty 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
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madunil Anuk Niriella
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Madunil Anuk Niriella, University of Kelaniya
- Investigators
- Aruni Hapangama, MBBS, MDPsych, FRANZCP, Study director, The Alfred Hospital, Melbourne, Victoria, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348628
- Sponsor's protocol ID
- P/38/04/2021
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.
PubMed 21440669Niriella MA, Pathmeswaran A, De Silva ST, Kasturiratna A, Perera R, Subasinghe CE, Kodisinghe K, Piyaratna C, Rishikesawan V, Dassanayaka AS, De Silva AP, Wickramasinghe R, Takeuchi F, Kato N, de Silva HJ. Incidence and risk factors for non-alcoholic fatty liver disease: A 7-year follow-up study among urban, adult Sri Lankans. Liver Int. 2017 Nov;37(11):1715-1722. doi: 10.1111/liv.13478. Epub 2017 Jun 10.
PubMed 28544258Hu XY, Li Y, Li LQ, Zheng Y, Lv JH, Huang SC, Zhang W, Liu L, Zhao L, Liu Z, Zhao XJ. Risk factors and biomarkers of non-alcoholic fatty liver disease: an observational cross-sectional population survey. BMJ Open. 2018 Apr 5;8(4):e019974. doi: 10.1136/bmjopen-2017-019974.
PubMed 29626047Hagstrom H, Nasr P, Ekstedt M, Hammar U, Stal P, Hultcrantz R, Kechagias S. Fibrosis stage but not NASH predicts mortality and time to development of severe liver disease in biopsy-proven NAFLD. J Hepatol. 2017 Dec;67(6):1265-1273. doi: 10.1016/j.jhep.2017.07.027. Epub 2017 Aug 10.
PubMed 28803953Kawamura Y, Arase Y, Ikeda K, Seko Y, Imai N, Hosaka T, Kobayashi M, Saitoh S, Sezaki H, Akuta N, Suzuki F, Suzuki Y, Ohmoto Y, Amakawa K, Tsuji H, Kumada H. Large-scale long-term follow-up study of Japanese patients with non-alcoholic Fatty liver disease for the onset of hepatocellular carcinoma. Am J Gastroenterol. 2012 Feb;107(2):253-61. doi: 10.1038/ajg.2011.327. Epub 2011 Oct 18.
PubMed 22008893Sarwar R, Pierce N, Koppe S. Obesity and nonalcoholic fatty liver disease: current perspectives. Diabetes Metab Syndr Obes. 2018 Sep 25;11:533-542. doi: 10.2147/DMSO.S146339. eCollection 2018.
PubMed 30288073Schubel R, Nonnenmacher T, Sookthai D, Gonzalez Maldonado S, Sowah SA, von Stackelberg O, Schlett CL, Grafetstatter M, Nabers D, Johnson T, Kirsten R, Ulrich CM, Kaaks R, Kauczor HU, Kuhn T, Nattenmuller J. Similar Weight Loss Induces Greater Improvements in Insulin Sensitivity and Liver Function among Individuals with NAFLD Compared to Individuals without NAFLD. Nutrients. 2019 Mar 4;11(3):544. doi: 10.3390/nu11030544.
PubMed 30836637Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.
PubMed 25865049Centis E, Moscatiello S, Bugianesi E, Bellentani S, Fracanzani AL, Calugi S, Petta S, Dalle Grave R, Marchesini G. Stage of change and motivation to healthier lifestyle in non-alcoholic fatty liver disease. J Hepatol. 2013 Apr;58(4):771-7. doi: 10.1016/j.jhep.2012.11.031. Epub 2012 Nov 29.
PubMed 23201248Stewart KE, Haller DL, Sargeant C, Levenson JL, Puri P, Sanyal AJ. Readiness for behaviour change in non-alcoholic fatty liver disease: implications for multidisciplinary care models. Liver Int. 2015 Mar;35(3):936-43. doi: 10.1111/liv.12483. Epub 2014 Mar 10.
PubMed 24521540Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.
PubMed 26029126Rodriguez-Cristobal JJ, Alonso-Villaverde C, Panisello JM, Trave-Mercade P, Rodriguez-Cortes F, Marsal JR, Pena E. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial. BMC Fam Pract. 2017 Jun 20;18(1):74. doi: 10.1186/s12875-017-0644-y.
PubMed 28633627Gelli C, Tarocchi M, Abenavoli L, Di Renzo L, Galli A, De Lorenzo A. Effect of a counseling-supported treatment with the Mediterranean diet and physical activity on the severity of the non-alcoholic fatty liver disease. World J Gastroenterol. 2017 May 7;23(17):3150-3162. doi: 10.3748/wjg.v23.i17.3150.
PubMed 28533672Mazzotti A, Caletti MT, Brodosi L, Di Domizio S, Forchielli ML, Petta S, Bugianesi E, Bianchi G, Marchesini G. An internet-based approach for lifestyle changes in patients with NAFLD: Two-year effects on weight loss and surrogate markers. J Hepatol. 2018 Nov;69(5):1155-1163. doi: 10.1016/j.jhep.2018.07.013. Epub 2018 Oct 2.
PubMed 30290973
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing for Weight Loss in the Management of Non Alcoholic Fatty Liver Disease - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06348628
- Acronym / sponsor ID
- P/38/04/2021
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Motivational Interview, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Madunil Anuk NiriellaUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 5 Apr 2024 (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.
The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD).
Detailed description
Participants with NAFLD who meet inclusion and exclusion criteria and who give informed written consent, will be randomly assigned to the intervention and control group. Randomization will be done by using a random sequence generator with concealed allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview with Placebo | Experimental | Behavioral: Motivational Interview, Behavioral: PlaceboEach participant receives a motivational interview session at the recruitment, 1, 3, 6 months. Simultaneously, They receive dietary, exercise and lifestyle advices. |
| Placebo | Placebo comparator | Behavioral: PlaceboParticipants receive dietary, exercise and lifestyle advices at the recruitment, 1, 3 and 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 years to 60 years
- Body Mass Index (BMI) is 25 kg/m^2 or more
- Newly diagnosed with NAFLD based on clinical history, ultrasound scan and laboratory values
Key exclusion criteria (7 listed)
- Any medical condition that will significantly alter the weight eg: hypothyroidism, hyperthyroidism, Cushing disease
- Having moderate/severe depressive disorders or psychotic symptoms and or substance use disorders that would reduce their capacity to give consent and engage in Motivational interview
- Who are on drugs which will affect weight or mood/affect (eg: corticosteroids)
- Pregnancy or expecting to be conceive within the study period
- Having any health conditions that would impede engagement in physical activities
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 |
|---|---|---|
| Motivational Interview4 Motivational interviews within first 6 months | Behavioural | Motivational Interview with Placebo |
| PlaceboAdvices on standard of care treatment of NAFLD within first 6 months | Behavioural | Motivational Interview with Placebo, Placebo |
Primary outcome
Change in weight after 1 year compared to baseline
Time frame: Baseline, 3 months, 6 months, 12 months
Weight is measured using a digital scale
Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline
Time frame: Baseline and 12 months
Lower AST and ALT levels have a better outcome
Change in platelet count after 1 year compared to baseline
Time frame: Baseline and 12 months
Lower platelet count has a poor outcome
Change in waist circumference and hip circumference after 1 year compared to baseline
Time frame: Baseline and 12 months
The waist circumference is measured at the narrowest part of the waist. The hip circumference is measured at the widest part of the hips. Both are measured by using a measuring tape.
Change in total fat percentage and visceral fat percentage after 1 year compared to baseline
Time frame: Baseline and 12 months
Both are measured by impedance method.
3 secondary outcomes
Change in motivation for weight loss after 1 year compared to baseline
Time frame: Baseline, 12 months
Change in depression, anxiety and stress after 1 year compared to baseline
Time frame: Baseline, 12 months
Change in quality of life after 1 year compared to baseline
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 21440669Younossi ZM, Stepanova M, Afendy M, Fang Y, Younossi Y, Mir H, Srishord M. Changes in the prevalence of the most common causes of chronic liver diseases in the United States from 1988 to 2008. Clin Gastroenterol Hepatol. 2011 Jun;9(6):524-530.e1; quiz e60. doi: 10.1016/j.cgh.2011.03.020. Epub 2011 Mar 25.
- Background: PubMed 28544258Niriella MA, Pathmeswaran A, De Silva ST, Kasturiratna A, Perera R, Subasinghe CE, Kodisinghe K, Piyaratna C, Rishikesawan V, Dassanayaka AS, De Silva AP, Wickramasinghe R, Takeuchi F, Kato N, de Silva HJ. Incidence and risk factors for non-alcoholic fatty liver disease: A 7-year follow-up study among urban, adult Sri Lankans. Liver Int. 2017 Nov;37(11):1715-1722. doi: 10.1111/liv.13478. Epub 2017 Jun 10.
- Background: PubMed 29626047Hu XY, Li Y, Li LQ, Zheng Y, Lv JH, Huang SC, Zhang W, Liu L, Zhao L, Liu Z, Zhao XJ. Risk factors and biomarkers of non-alcoholic fatty liver disease: an observational cross-sectional population survey. BMJ Open. 2018 Apr 5;8(4):e019974. doi: 10.1136/bmjopen-2017-019974.
- Background: PubMed 28803953Hagstrom H, Nasr P, Ekstedt M, Hammar U, Stal P, Hultcrantz R, Kechagias S. Fibrosis stage but not NASH predicts mortality and time to development of severe liver disease in biopsy-proven NAFLD. J Hepatol. 2017 Dec;67(6):1265-1273. doi: 10.1016/j.jhep.2017.07.027. Epub 2017 Aug 10.
- Background: PubMed 22008893Kawamura Y, Arase Y, Ikeda K, Seko Y, Imai N, Hosaka T, Kobayashi M, Saitoh S, Sezaki H, Akuta N, Suzuki F, Suzuki Y, Ohmoto Y, Amakawa K, Tsuji H, Kumada H. Large-scale long-term follow-up study of Japanese patients with non-alcoholic Fatty liver disease for the onset of hepatocellular carcinoma. Am J Gastroenterol. 2012 Feb;107(2):253-61. doi: 10.1038/ajg.2011.327. Epub 2011 Oct 18.
- Background: PubMed 30288073Sarwar R, Pierce N, Koppe S. Obesity and nonalcoholic fatty liver disease: current perspectives. Diabetes Metab Syndr Obes. 2018 Sep 25;11:533-542. doi: 10.2147/DMSO.S146339. eCollection 2018.
- Background: PubMed 30836637Schubel R, Nonnenmacher T, Sookthai D, Gonzalez Maldonado S, Sowah SA, von Stackelberg O, Schlett CL, Grafetstatter M, Nabers D, Johnson T, Kirsten R, Ulrich CM, Kaaks R, Kauczor HU, Kuhn T, Nattenmuller J. Similar Weight Loss Induces Greater Improvements in Insulin Sensitivity and Liver Function among Individuals with NAFLD Compared to Individuals without NAFLD. Nutrients. 2019 Mar 4;11(3):544. doi: 10.3390/nu11030544.
- Background: PubMed 25865049Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.
- Background: PubMed 23201248Centis E, Moscatiello S, Bugianesi E, Bellentani S, Fracanzani AL, Calugi S, Petta S, Dalle Grave R, Marchesini G. Stage of change and motivation to healthier lifestyle in non-alcoholic fatty liver disease. J Hepatol. 2013 Apr;58(4):771-7. doi: 10.1016/j.jhep.2012.11.031. Epub 2012 Nov 29.
- Background: PubMed 24521540Stewart KE, Haller DL, Sargeant C, Levenson JL, Puri P, Sanyal AJ. Readiness for behaviour change in non-alcoholic fatty liver disease: implications for multidisciplinary care models. Liver Int. 2015 Mar;35(3):936-43. doi: 10.1111/liv.12483. Epub 2014 Mar 10.
- Background: PubMed 26029126Ceccarini M, Borrello M, Pietrabissa G, Manzoni GM, Castelnuovo G. Assessing motivation and readiness to change for weight management and control: an in-depth evaluation of three sets of instruments. Front Psychol. 2015 May 11;6:511. doi: 10.3389/fpsyg.2015.00511. eCollection 2015.
- Background: PubMed 28633627Rodriguez-Cristobal JJ, Alonso-Villaverde C, Panisello JM, Trave-Mercade P, Rodriguez-Cortes F, Marsal JR, Pena E. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial. BMC Fam Pract. 2017 Jun 20;18(1):74. doi: 10.1186/s12875-017-0644-y.
- Individual participant dataSharing planned: No
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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.
Aruni Hapangama, MBBS, MDPsych, FRANZCP study director
The Alfred Hospital, Melbourne, Victoria, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview in people with Non-Alcoholic Fatty Liver Disease, run by Madunil Anuk Niriella at 1 site in Sri Lanka.
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 7 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: finished, as of the sponsor's last update on 30 Sep 2025. 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 Sri Lanka. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 weight after 1 year compared to baseline (time frame: Baseline, 3 months, 6 months, 12 months). The study lists 5 primary outcomes in all. 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 NCT06348628, which also lists 14 linked publications.
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 30 Sep 2025.