Obesity & OverweightKOBENCT07389122
Adherence and Tolerability of Four Very Low-Calorie Ketogenic Diet Approaches in Adults With Obesity or Complicated Overweight
An observational study of Obesity & Overweight and MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), run by University of Bologna at 1 site in Italy.
Trial summary
This study, called KOBE Study, looks at how well different very low-calorie ketogenic diets (VLCKD) are followed and tolerated by adults with obesity or complicated overweight in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Type 2 Diabetes
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 30 Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population includes all consecutive individuals who, in the context of routine clinical practice, meet the eligibility criteria for VLCKD therapy.
Who may be able to join
- Obesity with or without comorbidities (BMI ≥ 30 kg/m²) OR
- Overweight with comorbidity of MASLD (BMI 25.0-29.9 kg/m²) PLUS
- Previous unsuccessful attempt at a prescribed hypocaloric diet
Who cannot join
- Age < 18 years
- Pregnancy
- Breastfeeding
- Moderate or severe kidney failure
- Cardiovascular diseases: heart failure (NYHA III-IV), unstable angina, acute coronary syndrome or stroke within the past 12 months, paroxysmal atrial fibrillation, any type of atrioventricular block, left bundle branch block
- Liver diseases: Child-Pugh C, elevated transaminases with AST or ALT ≥ 5 times the upper limit of normal, INR ≥ 1.5, total bilirubin ≥ 2 mg/dL
Show all 11Show fewer
- Diabetes: type 1 diabetes mellitus, type 2 diabetes mellitus with insufficient pancreatic endocrine reserve (C-peptide < 0.8 ng/mL), type 2 diabetes mellitus on multiple daily insulin injections
- Last attempt of VLCKD outside the research protocol within the past 12 months
- Eating disorders: anorexia nervosa, bulimia nervosa, binge eating disorder
- Psychiatric comorbidities, alcohol or substance dependence
- Frail elderly patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KOBE Study: Adherence to and Tolerability of Different Very-low-calorie Ketogenic Protocols in Patients With Obesity and Complicated Overweight.
This study, called KOBE Study, looks at how well different very low-calorie ketogenic diets (VLCKD) are followed and tolerated by adults with obesity or complicated overweight in routine clinical practice.
Ketogenic diets are medical nutrition therapies that greatly reduce carbohydrates and calories to promote weight loss and improve metabolic health. Several VLCKD approaches are used in clinical care, but they differ in the type of protein sources used (natural foods versus meal replacements or supplements). At present, there is limited evidence comparing these approaches in terms of adherence, side effects, satisfaction, and dropout rates.
Read more
The KOBE Study is a single-center, prospective, observational study conducted during standard clinical care at a hospital nutrition clinic. Participants choose one of four VLCKD protocols based on personal preference:
- diets using only natural protein foods,
- natural proteins plus one protein supplement,
- natural proteins plus two meal replacements,
- or diets based entirely on meal replacements.
All participants follow the same structured program lasting about 26 weeks (longer for individuals with severe obesity), consisting of:
- an initial ketogenic phase,
- a gradual reintroduction of carbohydrates,
- a maintenance phase based on a low-glycemic index Mediterranean-style diet. Throughout the study, patients undergo routine clinical visits and assessments, including measurements of body weight, body composition, blood tests, liver imaging, and questionnaires on hunger, bowel habits, quality of life, and satisfaction with the diet. No additional tests beyond standard care are required.
The main goal of the study is to compare the different ketogenic protocols in terms of:
- how well patients can follow them,
- how well they are tolerated,
- the occurrence of side effects,
- and overall satisfaction. Secondary objectives include evaluating changes in body composition, metabolic parameters, and liver health.
The results of this study aim to help patients and healthcare professionals make more informed, evidence-based decisions when choosing among different ketogenic diet options for weight management and metabolic disease.
- Conditions
- Obesity & Overweight, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Type 2 Diabetes, Insulin Resistance
- Keywords
- ketogenic diet, meal replacement, pragmatic study, real-world evidence, obesity management, very-low-energy ketogenic therapy, weight loss
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | In arm A, protein intake was derived exclusively from natural food sources, with three or four daily meals according to individual energy and protein requirements. Protein sources included lean white meats (chicken, rabbit, turkey), lean red meats (veal and pork), lean and defatted cured meats (bresaola, cured and cooked ham), fish (gilthead seabream, cod, hake, trout), and 0% fat Greek yogurt. | |
| Arm B | In arm B, the same natural food sources were combined with one daily meal, corresponding to breakfast, based on whey protein supplementation. | |
| Arm C | In arm C, one or two daily meals, according to individual energy and protein requirements, consisted of natural foods, whereas the remaining two meals were provided as commercial meal replacement products. | |
| Arm D | In arm D, all daily meals consisted exclusively of commercial meal replacement products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence, collateral effects, drop-out, dietetic compliance
The primary objective of the study is to evaluate, within routine clinical practice and by comparing four distinct VLCKD protocols, the therapeutic response of patients in terms of:
(i) adherence (compliance), (ii) occurrence of adverse events, (iii) drop-out rate, and (iv) diet satisfaction.
The four ketogenic protocols routinely used in patients undergoing VLCKD each consist of three phases; only the first phase differs among protocols, based on patients' personal preferences.
Measured: Until the end of the study
Secondary outcomes (1)
Anthropometric Measures, Body Composition, Laboratory Parameters, and Imaging Evaluations
The secondary objectives are to evaluate the effects of the different VLCKD protocol arms on the trends of parameters collected during routine clinical practice, including:
(i) first- and second-level anthropometric measurements (body weight, Body Mass Index (BMI), and circumferences); (ii) body composition; (iii) biochemical laboratory tests according to the Società italiana di Endocrinologia (SIE) Consensus Statement, with particular attention to serum creatinine levels.
(iv) upper abdominal ultrasound and hepatic-splenic transient elastography assessed using the FibroScan technique.
Measured: Until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jul 2021
- Primary completion20 Aug 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Malpighi Hospital, Bologna, Italy
- Responsible party
- Principal investigator, Maria Letizia Petroni, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389122
- Sponsor's protocol ID
- 650/2021/Oss/AOUBo
- Acronym
- KOBE
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blake MR, Raker JM, Whelan K. Validity and reliability of the Bristol Stool Form Scale in healthy adults and patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2016 Oct;44(7):693-703. doi: 10.1111/apt.13746. Epub 2016 Aug 5.
PubMed 27492648Solah VA, Meng X, Wood S, Gahler RJ, Kerr DA, James AP, Pal S, Fenton HK, Johnson SK. Effect of training on the reliability of satiety evaluation and use of trained panellists to determine the satiety effect of dietary fibre: a randomised controlled trial. PLoS One. 2015 May 15;10(5):e0126202. doi: 10.1371/journal.pone.0126202. eCollection 2015.
PubMed 25978321Gibson AA, Seimon RV, Lee CM, Ayre J, Franklin J, Markovic TP, Caterson ID, Sainsbury A. Do ketogenic diets really suppress appetite? A systematic review and meta-analysis. Obes Rev. 2015 Jan;16(1):64-76. doi: 10.1111/obr.12230. Epub 2014 Nov 17.
PubMed 25402637Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
PubMed 31111407Castellana M, Conte E, Cignarelli A, Perrini S, Giustina A, Giovanella L, Giorgino F, Trimboli P. Efficacy and safety of very low calorie ketogenic diet (VLCKD) in patients with overweight and obesity: A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):5-16. doi: 10.1007/s11154-019-09514-y.
PubMed 31705259Gupta L, Khandelwal D, Kalra S, Gupta P, Dutta D, Aggarwal S. Ketogenic diet in endocrine disorders: Current perspectives. J Postgrad Med. 2017 Oct-Dec;63(4):242-251. doi: 10.4103/jpgm.JPGM_16_17.
PubMed 29022562Krebs HA. The regulation of the release of ketone bodies by the liver. Adv Enzyme Regul. 1966;4:339-54. doi: 10.1016/0065-2571(66)90027-6. No abstract available.
PubMed 4865971Westman EC, Tondt J, Maguire E, Yancy WS Jr. Implementing a low-carbohydrate, ketogenic diet to manage type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2018 Sep;13(5):263-272. doi: 10.1080/17446651.2018.1523713.
PubMed 30289048Watanabe M, Tozzi R, Risi R, Tuccinardi D, Mariani S, Basciani S, Spera G, Lubrano C, Gnessi L. Beneficial effects of the ketogenic diet on nonalcoholic fatty liver disease: A comprehensive review of the literature. Obes Rev. 2020 Aug;21(8):e13024. doi: 10.1111/obr.13024. Epub 2020 Mar 24.
PubMed 32207237Jagadish S, Payne ET, Wong-Kisiel L, Nickels KC, Eckert S, Wirrell EC. The Ketogenic and Modified Atkins Diet Therapy for Children With Refractory Epilepsy of Genetic Etiology. Pediatr Neurol. 2019 May;94:32-37. doi: 10.1016/j.pediatrneurol.2018.12.012. Epub 2018 Dec 29.
PubMed 30803845Freeman JM, Kossoff EH. Ketosis and the ketogenic diet, 2010: advances in treating epilepsy and other disorders. Adv Pediatr. 2010;57(1):315-29. doi: 10.1016/j.yapd.2010.08.003. No abstract available.
PubMed 21056745
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOBE Study: Adherence to and Tolerability of Different Very-low-calorie Ketogenic Protocols in Patients With Obesity and Complicated Overweight.
- ClinicalTrials.gov ID
- NCT07389122
- Acronym / sponsor ID
- KOBE / 650/2021/Oss/AOUBo
- Conditions
- Obesity & Overweight, MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Type 2 Diabetes, Insulin Resistance
- Keywords
- ketogenic diet, meal replacement, pragmatic study, real-world evidence, obesity management, very-low-energy ketogenic therapy, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- Malpighi Hospital, Bologna, Italy
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Feb 2026 (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.
This study, called KOBE Study, looks at how well different very low-calorie ketogenic diets (VLCKD) are followed and tolerated by adults with obesity or complicated overweight in routine clinical practice.
Ketogenic diets are medical nutrition therapies that greatly reduce carbohydrates and calories to promote weight loss and improve metabolic health. Several VLCKD approaches are used in clinical care, but they differ in the type of protein sources used (natural foods versus meal replacements or supplements). At present, there is limited evidence comparing these approaches in terms of adherence, side effects, satisfaction, and dropout rates.
The KOBE Study is a single-center, prospective, observational study conducted during standard clinical care at a hospital nutrition clinic. Participants choose one of four VLCKD protocols based on personal preference:
- diets using only natural protein foods,
- natural proteins plus one protein supplement,
- natural proteins plus two meal replacements,
- or diets based entirely on meal replacements.
All participants follow the same structured program lasting about 26 weeks (longer for individuals with severe obesity), consisting of:
- an initial ketogenic phase,
- a gradual reintroduction of carbohydrates,
- a maintenance phase based on a low-glycemic index Mediterranean-style diet. Throughout the study, patients undergo routine clinical visits and assessments, including measurements of body weight, body composition, blood tests, liver imaging, and questionnaires on hunger, bowel habits, quality of life, and satisfaction with the diet. No additional tests beyond standard care are required.
The main goal of the study is to compare the different ketogenic protocols in terms of:
- how well patients can follow them,
- how well they are tolerated,
- the occurrence of side effects,
- and overall satisfaction. Secondary objectives include evaluating changes in body composition, metabolic parameters, and liver health.
The results of this study aim to help patients and healthcare professionals make more informed, evidence-based decisions when choosing among different ketogenic diet options for weight management and metabolic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –In arm A, protein intake was derived exclusively from natural food sources, with three or four daily meals according to individual energy and protein requirements. Protein sources included lean white meats (chicken, rabbit, turkey), lean red meats (veal and pork), lean and defatted cured meats (bresaola, cured and cooked ham), fish (gilthead seabream, cod, hake, trout), and 0% fat Greek yogurt. |
| Arm B | – | –In arm B, the same natural food sources were combined with one daily meal, corresponding to breakfast, based on whey protein supplementation. |
| Arm C | – | –In arm C, one or two daily meals, according to individual energy and protein requirements, consisted of natural foods, whereas the remaining two meals were provided as commercial meal replacement products. |
| Arm D | – | –In arm D, all daily meals consisted exclusively of commercial meal replacement products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes all consecutive individuals who, in the context of routine clinical practice, meet the eligibility criteria for VLCKD therapy.
Key inclusion criteria (3 listed)
- Obesity with or without comorbidities (BMI ≥ 30 kg/m²) OR
- Overweight with comorbidity of MASLD (BMI 25.0-29.9 kg/m²) PLUS
- Previous unsuccessful attempt at a prescribed hypocaloric diet
Key exclusion criteria (11 listed)
- Age < 18 years
- Pregnancy
- Breastfeeding
- Moderate or severe kidney failure
- Cardiovascular diseases: heart failure (NYHA III-IV), unstable angina, acute coronary syndrome or stroke within the past 12 months, paroxysmal atrial fibrillation, any type of atrioventricular block, left bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence, collateral effects, drop-out, dietetic compliance
Time frame: Until the end of the study
The primary objective of the study is to evaluate, within routine clinical practice and by comparing four distinct VLCKD protocols, the therapeutic response of patients in terms of: (i) adherence (compliance), (ii) occurrence of adverse events, (iii) drop-out rate, and (iv) diet satisfaction. The four ketogenic protocols routinely used in patients undergoing VLCKD each consist of three phases; only the first phase differs among protocols, based on patients' personal preferences.
1 secondary outcome
Anthropometric Measures, Body Composition, Laboratory Parameters, and Imaging Evaluations
Time frame: Until the end of the study
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 4 May 2026.
- Background: PubMed 27492648Blake MR, Raker JM, Whelan K. Validity and reliability of the Bristol Stool Form Scale in healthy adults and patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2016 Oct;44(7):693-703. doi: 10.1111/apt.13746. Epub 2016 Aug 5.
- Background: PubMed 25978321Solah VA, Meng X, Wood S, Gahler RJ, Kerr DA, James AP, Pal S, Fenton HK, Johnson SK. Effect of training on the reliability of satiety evaluation and use of trained panellists to determine the satiety effect of dietary fibre: a randomised controlled trial. PLoS One. 2015 May 15;10(5):e0126202. doi: 10.1371/journal.pone.0126202. eCollection 2015.
- Background: PubMed 25402637Gibson AA, Seimon RV, Lee CM, Ayre J, Franklin J, Markovic TP, Caterson ID, Sainsbury A. Do ketogenic diets really suppress appetite? A systematic review and meta-analysis. Obes Rev. 2015 Jan;16(1):64-76. doi: 10.1111/obr.12230. Epub 2014 Nov 17.
- Background: PubMed 31111407Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
- Background: PubMed 31705259Castellana M, Conte E, Cignarelli A, Perrini S, Giustina A, Giovanella L, Giorgino F, Trimboli P. Efficacy and safety of very low calorie ketogenic diet (VLCKD) in patients with overweight and obesity: A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):5-16. doi: 10.1007/s11154-019-09514-y.
- Background: PubMed 29022562Gupta L, Khandelwal D, Kalra S, Gupta P, Dutta D, Aggarwal S. Ketogenic diet in endocrine disorders: Current perspectives. J Postgrad Med. 2017 Oct-Dec;63(4):242-251. doi: 10.4103/jpgm.JPGM_16_17.
- Background: PubMed 4865971Krebs HA. The regulation of the release of ketone bodies by the liver. Adv Enzyme Regul. 1966;4:339-54. doi: 10.1016/0065-2571(66)90027-6. No abstract available.
- Background: PubMed 30289048Westman EC, Tondt J, Maguire E, Yancy WS Jr. Implementing a low-carbohydrate, ketogenic diet to manage type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2018 Sep;13(5):263-272. doi: 10.1080/17446651.2018.1523713.
- Background: PubMed 32207237Watanabe M, Tozzi R, Risi R, Tuccinardi D, Mariani S, Basciani S, Spera G, Lubrano C, Gnessi L. Beneficial effects of the ketogenic diet on nonalcoholic fatty liver disease: A comprehensive review of the literature. Obes Rev. 2020 Aug;21(8):e13024. doi: 10.1111/obr.13024. Epub 2020 Mar 24.
- Background: PubMed 30803845Jagadish S, Payne ET, Wong-Kisiel L, Nickels KC, Eckert S, Wirrell EC. The Ketogenic and Modified Atkins Diet Therapy for Children With Refractory Epilepsy of Genetic Etiology. Pediatr Neurol. 2019 May;94:32-37. doi: 10.1016/j.pediatrneurol.2018.12.012. Epub 2018 Dec 29.
- Background: PubMed 21056745Freeman JM, Kossoff EH. Ketosis and the ketogenic diet, 2010: advances in treating epilepsy and other disorders. Adv Pediatr. 2010;57(1):315-29. doi: 10.1016/j.yapd.2010.08.003. No abstract available.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), run by University of Bologna at 1 site in Italy.
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 11 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 4 May 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 Italy. 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?
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?
Adherence, collateral effects, drop-out, dietetic compliance (time frame: Until the end of the study). 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 NCT07389122, which also lists 11 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 4 May 2026.