Non-Alcoholic Fatty Liver DiseasePhase 4NCT05942963
Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD
A Phase 4 study testing Empagliflozin 10 MG, Pioglitazone 15mg and Metformin in people with Non-Alcoholic Fatty Liver Disease and Type2diabetes, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Type2diabetes
- What is being tested?
- Empagliflozin 10 MG, Pioglitazone 15mg and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2023to Apr 2024
- Phase
- Phase 4
- 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
Who may be able to join
- T2DM patients with NAFLD glycated
- APRI scores of more than 1.5
Who cannot join
- Patients having type 1 diabetes
- evidence of advanced/decompensated cirrhosis (on the basis of a Child-Pugh score of more than 7 and MELD of more than 15)
- hepatocellular carcinoma (evidence on ultrasound or alpha-fetoprotein)
- patient suffering from acute or chronic hepatitis
- biliary disease
- HIV
Show all 18Show fewer
- hemochromatosis
- autoimmune conditions (alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease)
- renal dysfunction with GFR [eGFR] \<30 mL/min/1.73m2
- history of alcohol ( male \>30 g/d and female;20 g/d)
- history of cancer or undergoing treatment for cancer,
- use of amiodarone, tamoxifen, sodium valproate, corticosteroids, methotrexate, ursodeoxycholic acid, S-adenosyl methionine, betaine, silymarin, gemfibrozil
- using supplements including vitamin E, vitamin C, zinc, and selenium or antioxidant agents over the last 3 months
- history of cardiovascular events within the past 3 months
- pregnancy or breastfeeding
- contraindications to empagliflozin use (history of recurrent urogenital infections, current or previous gangrene, or hypersensitivity reaction to the molecule)
- history of bladder cancer
- morbid obesity (BMI greater than 35).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medical ICU, Jinnah Postgraduate Medical Centre
Karachi, Sindh, 71550
About this study
Official title: PEARL-DM: Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD; Randomized Controlled Trial From Pakistan.
This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.
Read the detailed description
This is a randomized clinical trial conducted to compare the efficacies of pioglitazone and empagliflozin in people suffering from NAFLD associated with T2DM.
Randomization will be done using card randomization. Four different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card
Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed.
Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participants name or any other personal details.
Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. The mean scores will be compared pre and post-intervention using paired t-test. The association of age, gender, and grade of fatty liver will be compared with different groups using correlation and regression models. All analyses will be at a confidence Interval of 95% and a p-value \<.05.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Type2diabetes
- Being tested
- Empagliflozin 10 MG, Pioglitazone 15mg, Metformin
- 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.
Empagliflozin 10 MGDrug
10-25 mg/day
Pioglitazone 15mgDrug
15-45 mg/day
MetforminDrug
1000mg-2850mg/ day
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | SOC+ Empagliflozin + Pioglitazone Receives: Drug: Empagliflozin 10 MG; Drug: Pioglitazone 15mg; Drug: Metformin |
| Group B | Experimental | SOC +Empagliflozin Receives: Drug: Empagliflozin 10 MG; Drug: Metformin |
| Group C | Experimental | SOC+ Pioglitazone Receives: Drug: Pioglitazone 15mg; Drug: Metformin |
| Group D | Active comparator | SOC only Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in liver steatosis will be assessed through fibro CAP score.
Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.
Measured: Will be assessed at enrollment.
A change in liver steatosis will be assessed through fibro CAP score.
Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.
Measured: Will be assessed at 168th day post enrollment.
Secondary outcomes (46)
change in SF-36 scores
36-Item Short Form Survey (SF-36) assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. A higher score defines a more favorable health state.
Measured: Quality of life will be assessed 84th day post enrollment.
change in SF-36 scores
36-Item Short Form Survey (SF-36) assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. A higher score defines a more favorable health state.
Measured: Quality of life will be assessed at day 252 post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Measured: at enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Measured: 84th day post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Measured: at 168th day post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Measured: at day 252 post enrollment.
change in liver fibrosis will be assessed through the APRI Score
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Measured: at enrollment.
change in liver fibrosis will be assessed through the APRI Score
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Measured: 84th day post enrollment.
change in liver fibrosis will be assessed through the APRI Score
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Measured: at 168th day post enrollment.
change in liver fibrosis will be assessed through the APRI Score.
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Measured: at day 252 post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Measured: at enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Measured: at 84th day post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Measured: at 168th day post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Measured: at day 252 post enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Measured: at enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Measured: at 84th day post enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Measured: at 168th day post enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Measured: at day 252 post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome.
Measured: at enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome.
Measured: at 84th day post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome
Measured: at 168th day post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome.
Measured: at day 252 post enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Measured: At enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Measured: 84th day post enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Measured: at 168th day post enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Measured: at day 252 post enrollment.
Change in weight
weight. lower the levels better the outcome.
Measured: at enrollment.
Change in weight
weight. lower the levels better the outcome.
Measured: at 84th day post enrollment.
Change in weight
weight. lower the levels better the outcome.
Measured: at 168th day post enrollment.
Change in weight
weight. lower the levels better the outcome.
Measured: at day 252 post enrollment.
Change in random blood sugar
random blood sugar
Measured: at enrollment.
Change in random blood sugar
random blood sugar.
Measured: at 84th day post enrollment.
Change in random blood sugar
random blood sugar.
Measured: at 168th day post enrollment.
Change in random blood sugar
random blood sugar. lower the levels better the outcome.
Measured: at day 252 post enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Measured: at enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Measured: at 84th day post enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Measured: at 168th day post enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Measured: at day 252 post enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Measured: at enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Measured: at 84th day post enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Measured: at 168th day post enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Measured: at day 252 post enrollment.
Change in Body mass index
Body mass index. lower the levels better the outcome.
Measured: at enrollment.
Change in body mass index
body mass index. lower the levels better the outcome.
Measured: at 84th day post enrollment.
Change in body mass index
body mass index. lower the levels better the outcome.
Measured: at 168th day post enrollment.
Change in body mass index
body mass index. lower the levels better the outcome.
Measured: at day 252 post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study startOct 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ZA, Jinnah Postgraduate Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942963
- Sponsor's protocol ID
- JSMU/IRB/2023/709
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEARL-DM: Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD; Randomized Controlled Trial From Pakistan.
- ClinicalTrials.gov ID
- NCT05942963
- Acronym / sponsor ID
- JSMU/IRB/2023/709
- Conditions
- Non-Alcoholic Fatty Liver Disease, Type2diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- Oct 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Jul 2023 (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 clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.
Detailed description
This is a randomized clinical trial conducted to compare the efficacies of pioglitazone and empagliflozin in people suffering from NAFLD associated with T2DM.
Randomization will be done using card randomization. Four different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card
Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed.
Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participants name or any other personal details.
Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. The mean scores will be compared pre and post-intervention using paired t-test. The association of age, gender, and grade of fatty liver will be compared with different groups using correlation and regression models. All analyses will be at a confidence Interval of 95% and a p-value \<.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Empagliflozin 10 MG, Drug: Pioglitazone 15mg, Drug: MetforminSOC+ Empagliflozin + Pioglitazone |
| Group B | Experimental | Drug: Empagliflozin 10 MG, Drug: MetforminSOC +Empagliflozin |
| Group C | Experimental | Drug: Pioglitazone 15mg, Drug: MetforminSOC+ Pioglitazone |
| Group D | Active comparator | Drug: MetforminSOC only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- T2DM patients with NAFLD glycated
- APRI scores of more than 1.5
Key exclusion criteria (18 listed)
- Patients having type 1 diabetes
- evidence of advanced/decompensated cirrhosis (on the basis of a Child-Pugh score of more than 7 and MELD of more than 15)
- hepatocellular carcinoma (evidence on ultrasound or alpha-fetoprotein)
- patient suffering from acute or chronic hepatitis
- biliary 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 |
|---|---|---|
| Empagliflozin 10 MG10-25 mg/day | Drug | Group A, Group B |
| Pioglitazone 15mg15-45 mg/day | Drug | Group A, Group C |
| Metformin1000mg-2850mg/ day | Drug | Group A, Group B, Group C, Group D |
Primary outcome
A change in liver steatosis will be assessed through fibro CAP score.
Time frame: Will be assessed at enrollment.
Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.
A change in liver steatosis will be assessed through fibro CAP score.
Time frame: Will be assessed at 168th day post enrollment.
Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.
46 secondary outcomes
change in SF-36 scores
Time frame: Quality of life will be assessed 84th day post enrollment.
change in SF-36 scores
Time frame: Quality of life will be assessed at day 252 post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Time frame: at enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Time frame: 84th day post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Time frame: at 168th day post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Time frame: at day 252 post enrollment.
change in liver fibrosis will be assessed through the APRI Score
Time frame: at enrollment.
change in liver fibrosis will be assessed through the APRI Score
Time frame: 84th day post enrollment.
change in liver fibrosis will be assessed through the APRI Score
Time frame: at 168th day post enrollment.
change in liver fibrosis will be assessed through the APRI Score.
Time frame: at day 252 post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
Time frame: at enrollment.
change in liver fibrosis will be assessed through the NFS Score.
Time frame: at 84th day post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
Time frame: at 168th day post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
Time frame: at day 252 post enrollment.
Change in hepatic steatosis through the FLI score.
Time frame: at enrollment.
Change in hepatic steatosis through the FLI score.
Time frame: at 84th day post enrollment.
Change in hepatic steatosis through the FLI score.
Time frame: at 168th day post enrollment.
Change in hepatic steatosis through the FLI score.
Time frame: at day 252 post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
Time frame: at enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
Time frame: at 84th day post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
Time frame: at 168th day post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
Time frame: at day 252 post enrollment.
Change in the LFT.
Time frame: At enrollment.
Change in the LFT.
Time frame: 84th day post enrollment.
Change in the LFT.
Time frame: at 168th day post enrollment.
Change in the LFT.
Time frame: at day 252 post enrollment.
Change in weight
Time frame: at enrollment.
Change in weight
Time frame: at 84th day post enrollment.
Change in weight
Time frame: at 168th day post enrollment.
Change in weight
Time frame: at day 252 post enrollment.
Change in random blood sugar
Time frame: at enrollment.
Change in random blood sugar
Time frame: at 84th day post enrollment.
Change in random blood sugar
Time frame: at 168th day post enrollment.
Change in random blood sugar
Time frame: at day 252 post enrollment.
Change in waist circumference
Time frame: at enrollment.
Change in waist circumference
Time frame: at 84th day post enrollment.
Change in waist circumference
Time frame: at 168th day post enrollment.
Change in waist circumference
Time frame: at day 252 post enrollment.
Change in HbA1c
Time frame: at enrollment.
Change in HbA1c
Time frame: at 84th day post enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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?
A Phase 4 study testing Empagliflozin 10 MG, Pioglitazone 15mg and Metformin in people with Non-Alcoholic Fatty Liver Disease and Type2diabetes, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 2 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
A change in liver steatosis will be assessed through fibro CAP score. (time frame: Will be assessed at enrollment.). 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?
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 12 Jul 2023.