Type 2 Diabetes MellitusNCT05472272
Low-Calorie Diets on Type 2 Diabetes Remission
A study testing Formula diet and Food-based diet in people with Type 2 Diabetes Mellitus and Obesity, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The prevalence of type 2 diabetes mellitus (T2DM) has been increasing rapidly in China. China currently has ~130 million diabetes cases, and over 90% are T2DM. T2DM is a leading cause of morbidity and mortality, posing substantial clinical and public health challenges. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity, Overweight
- What is being tested?
- Formula diet and Food-based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2022to 18 Feb 2024
- 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
- Physician-diagnosed T2DM
- Most recent HbA1c level: 6.5%-12.0%
- Body mass index: 24-45 kg/m2
- Informed consent signed by participants in this study in accordance with requirements of local regulations and the Ethical Review Committee
- No plan to leave Shanghai in 2 years
Who cannot join
- Type 1 diabetes
- Current use of insulin and glucagon-like peptide-1 receptor agonists
- Major cardiovascular events (e.g., myocardial infarction, stroke, and heart failure) within the previous 6 months
- Weight loss >5 kg within the past 6 months
- Diagnosed eating disorders or any dieting behaviors
- Chronic kidney disease stage 3b or higher (estimated glomerular filtration rate <30 milliliter /min/1.73m2)
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- Previously diagnosed psychiatric disorders, e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder, uncontrolled depression, uncontrolled epilepsy
- Severe arthritis and gout
- Gallstone disease or known asymptomatic gallstones
- Participation in another clinical research trial
- Being pregnant or have a positive pregnancy test result at screening, or have given birth within the past 90 days, or who are breastfeeding.
- Any known cancers
- Learning difficulties
- Alcoholism
- Pancreatitis
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Effect of Low-Calorie Diets on Remission of Type 2 Diabetes: A Feasibility Study
The prevalence of type 2 diabetes mellitus (T2DM) has been increasing rapidly in China. China currently has ~130 million diabetes cases, and over 90% are T2DM. T2DM is a leading cause of morbidity and mortality, posing substantial clinical and public health challenges. Reversing T2DM with a significant amount of weight loss via consuming a low-calorie diet is possible, but no studies have been conducted to determine whether low-calorie diets will help achieve significant weight loss and diabetes remission among Chinese patients with T2DM. The investigators design a pilot study to assess the feasibility of a low-calorie diet intervention program on weight loss and diabetes remission in a Chinese population with T2DM.
Read the detailed description
Consistent evidence has shown that overweight and obesity are the leading cause of T2DM, which exacerbates the development of insulin resistance and disease progression. For overweight and obese patients with T2DM, there is a strong consensus that sustained and moderate weight loss can effectively improve glycemic control and blood pressure as well as reduce the need for glucose-lowering medications and improve quality of life.
Short-term dietary interventions using structured low-calorie diets (800-1,000 kcal/day) have shown to be an effective approach for losing weight and promoting sustained diabetes remission in T2DM patients who are overweight or obese. The United Kingdom DiRECT research team designed a structured, intensive intervention program of 12-20 weeks to achieve substantial weight loss and T2DM remission through energy restriction. Researchers recorded ≥15 kg of weight loss in 24% of the participants who underwent a low-calorie formula diet intervention (total diet replacement with 825-853 kcal/day formula low-energy diet meal replacement products). Among these participants, the diabetes remission rate reached 90%.
This non-randomized dietary intervention study comprises 2 study arms: a formula diet (815-835 kcal/day) and a food-based diet (815-835 kcal/day). Participants will be on either of the two low-calorie diets for 12 weeks to achieve at least 12 kg of weight loss (intensive weight loss phase). Participants may extend the weight loss phase if desired. After 12 weeks, participants in the formula diet group are allowed to consume actual meals gradually, and participants in both groups will increase their energy consumption gradually over the next 12 weeks (weight loss achievement and maintenance phase). Physical activity is recommended during the second phase for maintaining weight loss. This study is designed to assess feasibility of the low-calorie diet intervention, in preparation for a full-scale randomized control study. This pilot study also plans to explore potential mechanisms of the intervention for weight loss and diabetes remission.
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Overweight
- Being tested
- Formula diet, Food-based diet
- Keywords
- Type 2 diabetes, Diabetes mellitus, Weight loss, Diet, Lifestyle intervention, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula dietOther
Participants will receive a low-calorie (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) formula diet product for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.
Food-based dietOther
Participants will receive a low-calorie (815-835 kcal/day; 45-50% carbohydrate, 20-30% protein, and 20-30% fat) food-based diet created by dietitians for 12 weeks. After 12 weeks, participants will increase energy intake gradually and be encouraged to increase daily physical activity to maintain weight loss for another 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Formula Diet | Experimental | Participants will receive a low-calorie formula diet product. Receives: Other: Formula diet |
| Food-Based Diet | Experimental | Participants will receive a low-calorie food-based diet created by dietitians. Receives: Other: Food-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of adherence to the intervention
Percent of adherence is calculated at the end of the intervention by dividing the number of participants who remain in and adhere to the intervention by the total number of participants who participate in the intervention.
Measured: Baseline to 24 weeks
Percent of participants achieving significant weight loss and diabetes remission
Proportion of participants achieving significant weight loss (≥12kg) and diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months, will be estimated at 24 weeks.
Measured: Baseline to 24 weeks
Secondary outcomes (19)
Aggregated safety assessment
Glutathione, glutathione, total bilirubin, direct bilirubin, indirect bilirubin, urea nitrogen, creatinine, blood cell sorting count, urine routine, and adverse events are measured or recorded at the pre-specified time points to reflect number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Measured: Baseline to 24 weeks
Insulin sensitivity
Insulin sensitivity is evaluated with insulin tolerance tests at the pre-specified time points.
Measured: Baseline to 24 weeks
Beta cell function
Beta cell function is evaluated with arginine stimulation test at the pre-specified time points.
Measured: Baseline to 24 weeks
Level of fasting glucose
Level of fasting glucose is measured using a blood sample from a finger stick when participants have an empty stomach (refraining from eating of drinking any liquids other than water for eight hours) at the pre-specified time points.
Measured: Baseline to 24 weeks
Level of postprandial glucose
Level of postprandial glucose is measured using a blood sample from a finger stick two-hour later after participants eat their meals at the pre-specified time points.
Measured: Baseline to 24 weeks
Level of HbA1c
Level of HbA1c is measured using a blood sample from a finger stick at the pre-specified time points.
Measured: Baseline to 24 weeks
Glucose homeostasis
Time in Range, Time Above Range, and Time Below Range are measured at the pre-specified time points using continuous glucose monitor data.
Measured: Baseline to 24 weeks
Body fat composition and fat distribution
Dual-energy X-ray absorptiometry scan is used for quantifying body composition. Magnetic resonance imaging scan is used to quantify fat in the liver and pancreas at the pre-specified time points.
Measured: Baseline to 24 weeks
Gut microbiota
Metagenomic sequencing of fecal samples is performed to study gut microbiota including bacteria, fungi, archaea, and viruses at the pre-specified time points.
Measured: Baseline to 24 weeks
Traditional Chinese Medicine(TCM) tongue diagnosis estimated by tongue-face diagnosis instrument
Parameters of tongue nature and tongue coating are estimated by tongue-face diagnosis instrument to detect hyperglycemic changes at the pre-specified time points.
Measured: Baseline to 24 weeks
TCM facial diagnosis estimated by tongue-face diagnosis instrument
The changes of face complexion and surface gloss are estimated by tongue-face diagnosis instrument to reveal pathological changes of different viscera and bowels with different natures at the pre-specified time points.
Measured: Baseline to 24 weeks
Health-related quality of life
The European Quality of Life 5-dimension 5-level questionnaire will be used to measure health-related quality of life at the pre-specified time points. The scale is numbered from 0 to 100. 100 measn the best health condition, and 0 means the worst health condition.
Measured: Baseline to 24 weeks
Diet
The food frequency questionnaire will be used to assess diet and eating behaviors at the pre-specified time points.
Measured: Baseline to 24 weeks
Binge eating behaviors
The binge eating scale will be used to assess the presence of binge eating behavior indicative of an eating disorder at the pre-specified time points (less than 17: non-binging; 18-26: moderate binging; 27 and greater: severe binging).
Measured: Baseline to 24 weeks
Diet and eating behaviors
The three-factor eating questionnaire will be used to assess diet and eating behaviors at the pre-specified time points. All items are coded with either 0 or 1 point leading to maximum sum scores of 21 points for the domain of 'cognitive restraint', 16 points for 'disinhibition' and 14 points for 'hunger'. Higher scores indicate stronger characteristic values in the domains.
Measured: Baseline to 24 weeks
Psychological status-Anxiety
The Self-Rating Anxiety Scale will be used to measure anxiety level at the pre-specified time points (20-44 normal range. 45-59 mild to moderate anxiety, 60-74 severe).
Measured: Baseline to 24 weeks
Psychological status-Depression
Patient Health Questionaire-9 will be used to measure depression level at the pre-specified time points (0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe).
Measured: Baseline to 24 weeks
Sleep quality
The Pittsburgh Sleep Quality Index will be used to measure sleep quality at the pre-specified time points. The scores range from 0 to 21 and a score >5 be considered as a significant sleep disturbance. Higher scores indicate worse sleep quality.
Measured: Baseline to 24 weeks
Metabolomic profiling performed by liquid chromatography mass spectrometry
The liquid chromatography mass spectrometry (LC-MS) approach will be used to identify metabolites, pathways and networks that are associated with dietary interventions at the pre-specified time points. The major classes of metabolites including amino acids, carbohydrates, nucleotides, lipids, coenzymes, and cofactors are aggregated to demonstrate metabolic patterns.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start3 Aug 2022
- Primary completion18 Feb 2024
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized parallel study without a control arm
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Feng Tao, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Investigators
- Victor Wenze Zhong, Ph.D., Principal investigator, Shanghai Jiao Tong University School of MedicineFeng Tao, Ph.D., Principal investigator, Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472272
- Sponsor's protocol ID
- SHMHTCM DM
- Status last verified
- May 2024
- First submitted
- 9 Jul 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data materials will publish articles
Publications
Shi S, Wang S, Wu D, Li K, Yang G, Xu L, Feng N, Du X, Zhong VW. Epigenetic Signatures of Type 2 Diabetes Remission and Substantial Weight Loss: The Role of DNA Methylation in Response to Low-Calorie Diet Intervention. J Am Nutr Assoc. 2025 Nov-Dec;44(8):765-776. doi: 10.1080/27697061.2025.2513378. Epub 2025 Jun 5.
PubMed 40471649Liu Z, Feng N, Wang S, Liu Y, Wang J, Tan Y, Dong Y, Sun Z, Du X, Xu Y, Tao F, Zhong VW. Low-calorie diets and remission of type 2 diabetes in Chinese: phenotypic changes and individual variability. Nutr J. 2025 Mar 14;24(1):42. doi: 10.1186/s12937-025-01101-z.
PubMed 40087696
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Calorie Diets on Remission of Type 2 Diabetes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05472272
- Acronym / sponsor ID
- SHMHTCM DM
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Overweight
- Keywords
- Type 2 diabetes, Diabetes mellitus, Weight loss, Diet, Lifestyle intervention, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 25 Jul 2022 (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 prevalence of type 2 diabetes mellitus (T2DM) has been increasing rapidly in China. China currently has ~130 million diabetes cases, and over 90% are T2DM. T2DM is a leading cause of morbidity and mortality, posing substantial clinical and public health challenges. Reversing T2DM with a significant amount of weight loss via consuming a low-calorie diet is possible, but no studies have been conducted to determine whether low-calorie diets will help achieve significant weight loss and diabetes remission among Chinese patients with T2DM. The investigators design a pilot study to assess the feasibility of a low-calorie diet intervention program on weight loss and diabetes remission in a Chinese population with T2DM.
Detailed description
Consistent evidence has shown that overweight and obesity are the leading cause of T2DM, which exacerbates the development of insulin resistance and disease progression. For overweight and obese patients with T2DM, there is a strong consensus that sustained and moderate weight loss can effectively improve glycemic control and blood pressure as well as reduce the need for glucose-lowering medications and improve quality of life.
Short-term dietary interventions using structured low-calorie diets (800-1,000 kcal/day) have shown to be an effective approach for losing weight and promoting sustained diabetes remission in T2DM patients who are overweight or obese. The United Kingdom DiRECT research team designed a structured, intensive intervention program of 12-20 weeks to achieve substantial weight loss and T2DM remission through energy restriction. Researchers recorded ≥15 kg of weight loss in 24% of the participants who underwent a low-calorie formula diet intervention (total diet replacement with 825-853 kcal/day formula low-energy diet meal replacement products). Among these participants, the diabetes remission rate reached 90%.
This non-randomized dietary intervention study comprises 2 study arms: a formula diet (815-835 kcal/day) and a food-based diet (815-835 kcal/day). Participants will be on either of the two low-calorie diets for 12 weeks to achieve at least 12 kg of weight loss (intensive weight loss phase). Participants may extend the weight loss phase if desired. After 12 weeks, participants in the formula diet group are allowed to consume actual meals gradually, and participants in both groups will increase their energy consumption gradually over the next 12 weeks (weight loss achievement and maintenance phase). Physical activity is recommended during the second phase for maintaining weight loss. This study is designed to assess feasibility of the low-calorie diet intervention, in preparation for a full-scale randomized control study. This pilot study also plans to explore potential mechanisms of the intervention for weight loss and diabetes remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized parallel study without a control arm
| Arm | Type | Receives |
|---|---|---|
| Formula Diet | Experimental | Other: Formula dietParticipants will receive a low-calorie formula diet product. |
| Food-Based Diet | Experimental | Other: Food-based dietParticipants will receive a low-calorie food-based diet created by dietitians. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Physician-diagnosed T2DM
- Most recent HbA1c level: 6.5%-12.0%
- Body mass index: 24-45 kg/m2
- Informed consent signed by participants in this study in accordance with requirements of local regulations and the Ethical Review Committee
- No plan to leave Shanghai in 2 years
Key exclusion criteria (15 listed)
- Type 1 diabetes
- Current use of insulin and glucagon-like peptide-1 receptor agonists
- Major cardiovascular events (e.g., myocardial infarction, stroke, and heart failure) within the previous 6 months
- Weight loss >5 kg within the past 6 months
- Diagnosed eating disorders or any dieting behaviors
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 |
|---|---|---|
| Formula dietParticipants will receive a low-calorie (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) formula diet product for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks. | Other | Formula Diet |
| Food-based dietParticipants will receive a low-calorie (815-835 kcal/day; 45-50% carbohydrate, 20-30% protein, and 20-30% fat) food-based diet created by dietitians for 12 weeks. After 12 weeks, participants will increase energy intake gradually and be encouraged to increase daily physical activity to maintain weight loss for another 12 weeks. | Other | Food-Based Diet |
Primary outcome
Percent of adherence to the intervention
Time frame: Baseline to 24 weeks
Percent of adherence is calculated at the end of the intervention by dividing the number of participants who remain in and adhere to the intervention by the total number of participants who participate in the intervention.
Percent of participants achieving significant weight loss and diabetes remission
Time frame: Baseline to 24 weeks
Proportion of participants achieving significant weight loss (≥12kg) and diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months, will be estimated at 24 weeks.
19 secondary outcomes
Aggregated safety assessment
Time frame: Baseline to 24 weeks
Insulin sensitivity
Time frame: Baseline to 24 weeks
Beta cell function
Time frame: Baseline to 24 weeks
Level of fasting glucose
Time frame: Baseline to 24 weeks
Level of postprandial glucose
Time frame: Baseline to 24 weeks
Level of HbA1c
Time frame: Baseline to 24 weeks
Glucose homeostasis
Time frame: Baseline to 24 weeks
Body fat composition and fat distribution
Time frame: Baseline to 24 weeks
Gut microbiota
Time frame: Baseline to 24 weeks
Traditional Chinese Medicine(TCM) tongue diagnosis estimated by tongue-face diagnosis instrument
Time frame: Baseline to 24 weeks
TCM facial diagnosis estimated by tongue-face diagnosis instrument
Time frame: Baseline to 24 weeks
Health-related quality of life
Time frame: Baseline to 24 weeks
Diet
Time frame: Baseline to 24 weeks
Binge eating behaviors
Time frame: Baseline to 24 weeks
Diet and eating behaviors
Time frame: Baseline to 24 weeks
Psychological status-Anxiety
Time frame: Baseline to 24 weeks
Psychological status-Depression
Time frame: Baseline to 24 weeks
Sleep quality
Time frame: Baseline to 24 weeks
Metabolomic profiling performed by liquid chromatography mass spectrometry
Time frame: Baseline to 24 weeks
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 16 May 2024.
- Derived from this study: PubMed 40471649Shi S, Wang S, Wu D, Li K, Yang G, Xu L, Feng N, Du X, Zhong VW. Epigenetic Signatures of Type 2 Diabetes Remission and Substantial Weight Loss: The Role of DNA Methylation in Response to Low-Calorie Diet Intervention. J Am Nutr Assoc. 2025 Nov-Dec;44(8):765-776. doi: 10.1080/27697061.2025.2513378. Epub 2025 Jun 5.
- Derived from this study: PubMed 40087696Liu Z, Feng N, Wang S, Liu Y, Wang J, Tan Y, Dong Y, Sun Z, Du X, Xu Y, Tao F, Zhong VW. Low-calorie diets and remission of type 2 diabetes in Chinese: phenotypic changes and individual variability. Nutr J. 2025 Mar 14;24(1):42. doi: 10.1186/s12937-025-01101-z.
- Individual participant dataSharing planned: No. Individual participant data materials will publish articles
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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.
Victor Wenze Zhong, Ph.D. principal investigator
Shanghai Jiao Tong University School of Medicine
Feng Tao, Ph.D. principal investigator
Department of Endocrinology, Shanghai Municipal Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula diet and Food-based diet in people with Type 2 Diabetes Mellitus and Obesity, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
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 5 inclusion and 15 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 16 May 2024. 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 China. 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?
Percent of adherence to the intervention (time frame: Baseline to 24 weeks). The study lists 2 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 NCT05472272, which also lists 2 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 16 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.