NASH - Nonalcoholic SteatohepatitisPhase 2LEGENDNCT05232071

Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

A Phase 2 study testing Lanifibranor and Empagliflozin in people with NASH - Nonalcoholic Steatohepatitis and Diabetes Mellitus, Type 2, run by Inventiva Pharma at 42 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
What is being tested?: Lanifibranor and Empagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 42 sitesin 5 countries
Study dates: 29 Jun 2022to 4 Jun 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female, aged ≥ 18 years at the time of signing informed consent
Diagnosis of NASH, based on histology or cT1≥875ms assessed by LiverMultiScan or cT1≥825ms assessed by LiverMultiScan and hepatic fat content ≥ 10% assessed by MRI-PDFF at screening
HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months
Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.

Who cannot join

Liver-related:
Documented causes of chronic liver disease other than NASH
Histologically documented liver cirrhosis (fibrosis stage F4)
History or current diagnosis of hepatocellular carcinoma (HCC)
History of or planned liver transplant
Documented history of human immunodeficiency virus (HIV) infection

Show all 29Show fewer

ALT or AST > 5 × upper limit of normal (ULN)
Abnormal liver function as defined by central laboratory evaluation:
Albumin < LLN INR ≥ 1.3 (unless patient is on anticoagulants) Total bilirubin level ≥ 1.5 mg/dL (25.7 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is ≤ 0.45 mg/dL (7.7 μmol/L) )
Hemoglobin < 110 g/L (11 g/dL) for females and < 120 g/L (12 g/dL) for males
WBC < LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator
Platelet count < 140,000/µL
ALP > 2 × ULN
Patient currently receiving any approved treatment for NASH or obesity
Current or recent history (< 5 years) of significant alcohol consumption
Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.
Diabetes related:
Diabetes mellitus other than type 2
Diabetic ketoacidosis at Screening
Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening
Patients on pioglitazone in the last 12 months prior to Screening.
Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels, unless on stable doses in last 3 months
Obesity related:
BMI>45 kg/m2 at screening
Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12 months prior to Screening or planned bariatric surgery through Week 24.
Cardiovascular related:
21. History of or current unstable cardiac dysrhythmias 22. Unstable heart failure 23. Uncontrolled hypertension 24. Stroke or transient ischemic attack
General safety:
25. Significant systemic or major illnesses other than liver disease and pulmonary disease, organ transplantation, serious psychiatric disease, that, in the opinion of the investigator, would preclude treatment with lanifibranor and/or adequate follow up 26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min 27. Concomitant treatment with PPAR-⍺ agonists (fibrates) 28. Patients on Vitamin E at doses ≥ 400 IU/day; doses of ≥ 400 IU/day are allowed when no qualitative change in dose for 6 months prior to Screening 29. Have a known hypersensitivity to any of the IMPs 30. Previous exposure to lanifibranor or empagliflozin 31. Present pregnancy/lactation 32. Metallic implant of any sort that prevents MRI examination 33. Participation in any clinical trial of an approved or non approved investigational medicinal product/device within 3 months from Screening or five half-lives of the investigational drug from Screening.

Trial locations and contacts

42 sites in 5 countries.

Country

City, postcode or hospital

42 sites in 5 countries

United States26 sites

Accelemed Research Institute
Austin, Texas, 78745
Harvard Medical School
Boston, Massachusetts, 02115
Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, 85224
University of Virginia
Charlottesville, Virginia, 22908
ARcare Center for Clinical Research
Conway, Arkansas, 72032
Dallas Diabetes Research Center
Dallas, Texas, 75230
AIG Digestive Disease Research
Florham Park, New Jersey, 07932
Cure Clinical Research, LLC
Fountain Valley, California, 92708
Velocity Clinical Research
Gardena, California, 90247
Digestive Health Research
Hermitage, Tennessee, 37076
Birmingham Digestive Health Research
Homewood, Alabama, 35209
National Research Institute
Huntington Park, California, 90255
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Florida Research Institute
Lakewood Rch, Florida, 34211
Galenus Group
Lehigh Acres, Florida, 33936
ARcare Center for Clinical Research
Little Rock, Arkansas, 72205
Tandem Clinical Research - New Orleans Area Site
Marrero, Louisiana, 70072
Prolive Medical Research
Miami, Florida, 33175
Cadena Care Institute, LLC
Poway, California, 92064
Central Virginia VA Healthcare System
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
American Research Corporation
San Antonio, Texas, 78215
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Digestive Health Research of Southern California
South Bend, Indiana, 46635
Impact Research Institute
Waco, Texas, 76710
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301

Other trials in United States

France6 sites

CHU Angers_Service d'hepatogastro-enterologie
Angers, 49000
CHU Limoges
Limoges, 87042
Hopital Saint Antoine
Paris, 75012
CHU Bordeaux
Pessac, 33604
Chu Rangueil
Toulouse, 31059
HGE CHRU Nancy
Vandœuvre-lès-Nancy, 54500

Other trials in France

Belgium5 sites

CUB Erasme Hospital
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
AZ Maria Middelares
Ghent, 9000
UZ GENT
Ghent, 9000

Other trials in Belgium

United Kingdom4 sites

Hull University Teaching Hospital
Hull, HU32JZ
King's College Hospital
London, SE59RS
St Georges Hospital
London, SW17 0QT
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 7RU

Other trials in United Kingdom

Netherlands1 site

Amsterdam UMC
Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

Conditions: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Being tested: Lanifibranor, Placebo, Empagliflozin
Medical subject headings: Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LanifibranorDrug
800 mg
PlaceboDrug
Placebo to match
EmpagliflozinDrug
Also called Jardiance
10 mg

Study groups in NCT05232071
Study group	Role	What they receive
Lanifibranor (800 mg/day)	Experimental	Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each, once-a-day (QD) with food. For oral use. QD for 24 weeks. Receives: Drug: Lanifibranor
Matching placebo	Placebo comparator	Two lanifibranor placebo-matching tablets once-a-day (QD) with food. For oral use. QD for 24 weeks. Receives: Drug: Placebo
Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day)	Experimental	Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each plus one empagliflozin film-coated tablet of 10 mg (10mg/day), once-a-day (QD) with food. For oral use. QD for 24 weeks Receives: Drug: Lanifibranor; Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change in HbA1c
Effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24
Measured: From Baseline to Week 24

Secondary outcomes (8)

Change in Liver Tests (ALT)
Defined as Absolute Change from Baseline
Measured: from Baseline to Week 24
Change in Liver Tests (AST)
Defined as Absolute Change from Baseline
Measured: from Baseline to Week 24
Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)
HOMA-IR : The homeostatic model assessment for insulin resistance (HOMA-IR) is a method used to quantify insulin resistance, and was derived by the central laboratory from glucose and insulin values using the formula (Fasting glucose mg/dL x fasting insulin µIU/mL) / 405.
Lower values are considered better outcome.
Measured: from Baseline to Week 24
Change in Insulin Resistance and Glycaemic Control (Insulin)
Defined as Relative Change from Baseline
Measured: from Baseline to Week 24
Change in Insulin Resistance and Glycaemic Control (Adiponectin)
Defined as Fold Change from Baseline
Measured: from Baseline to Week 24
Change in Lipid Parameters (HDL Cholesterol)
Defined as Relative Change
Measured: from Baseline to Week 24
Change in Body Weight and Body Composition (Body Weight)
Defined as Relative Change from Baseline
Measured: from Baseline to Week 24
Change in Body Weight and Body Composition (VAT/SAT Ratio)
Ratio VAT / SAT - Results for Relative Change from Baseline VAT : MRI L3 visceral adipose tissue SAT : MRI L3 subcutaneous adipose tissue
Measured: from Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20224 Jun 2024

First posted9 Feb 2022
Study start29 Jun 2022
Primary completion8 May 2024
Study completion4 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05232071
Sponsor's protocol ID: 337HNAS21016
Other IDs: 2021-005057-87
Acronym: LEGEND
Status last verified: Sep 2026
First submitted: 26 Jan 2022
Last updated: 9 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
ClinicalTrials.gov ID: NCT05232071
Acronym / sponsor ID: LEGEND / 337HNAS21016
Conditions: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Inventiva PharmaIndustry (pharma, biotech, devices)
Study start: 29 Jun 2022 (actual)
Primary completion: 8 May 2024 (actual)
Study completion: 4 Jun 2024 (actual)
First posted: 9 Feb 2022 (actual)
Results: Posted 9 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lanifibranor (800 mg/day)	Experimental	Drug: LanifibranorLanifibranor (800 mg/day): two film-coated tablets of 400 mg each, once-a-day (QD) with food. For oral use. QD for 24 weeks.
Matching placebo	Placebo comparator	Drug: PlaceboTwo lanifibranor placebo-matching tablets once-a-day (QD) with food. For oral use. QD for 24 weeks.
Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day)	Experimental	Drug: Lanifibranor, Drug: EmpagliflozinLanifibranor (800 mg/day): two film-coated tablets of 400 mg each plus one empagliflozin film-coated tablet of 10 mg (10mg/day), once-a-day (QD) with food. For oral use. QD for 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, aged ≥ 18 years at the time of signing informed consent
Diagnosis of NASH, based on histology or cT1≥875ms assessed by LiverMultiScan or cT1≥825ms assessed by LiverMultiScan and hepatic fat content ≥ 10% assessed by MRI-PDFF at screening
HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months
Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.

Key exclusion criteria (29 listed)

Documented causes of chronic liver disease other than NASH
Histologically documented liver cirrhosis (fibrosis stage F4)
History or current diagnosis of hepatocellular carcinoma (HCC)
History of or planned liver transplant
Documented history of human immunodeficiency virus (HIV) infection

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
Lanifibranor800 mg	Drug	Lanifibranor (800 mg/day), Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day)
PlaceboPlacebo to match	Drug	Matching placebo
EmpagliflozinAlso: Jardiance10 mg	Drug	Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day)

Primary outcome

Absolute Change in HbA1c
Time frame: From Baseline to Week 24
Effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24

8 secondary outcomes

Change in Liver Tests (ALT)
Time frame: from Baseline to Week 24
Change in Liver Tests (AST)
Time frame: from Baseline to Week 24
Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)
Time frame: from Baseline to Week 24
Change in Insulin Resistance and Glycaemic Control (Insulin)
Time frame: from Baseline to Week 24
Change in Insulin Resistance and Glycaemic Control (Adiponectin)
Time frame: from Baseline to Week 24
Change in Lipid Parameters (HDL Cholesterol)
Time frame: from Baseline to Week 24
Change in Body Weight and Body Composition (Body Weight)
Time frame: from Baseline to Week 24
Change in Body Weight and Body Composition (VAT/SAT Ratio)
Time frame: from Baseline to Week 24

Results and safety

Results posted to the registry on 9 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanifibranor (800 mg/Day)	12	12
Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)	13	12
Placebo	14	9

Primary outcome: Absolute Change in HbA1c

Time frame: From Baseline to Week 24. Least squares mean (95% Confidence Interval). Unit: percentage of glycosylated hemoglobin

Measure	Lanifibranor (800 mg/Day) n = 11	Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day) n = 13	Placebo n = 13
Value	-1.11 (-1.6 to -0.62)	-1.54 (-2.02 to -1.06)	0.16 (-0.32 to 0.63)

Lanifibranor (800 mg/Day) vs Placebo: LS mean Difference (LSM): -1.27 (95% CI -1.95 to -0.58), p < 0.001, Mixed Models Analysis
Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day) vs Placebo: LS mean Difference (LSM): -1.7 (95% CI -2.38 to -1.02), p < 0.001, Mixed Models Analysis

Population analysed: Two patients were not considered in the MMRM analysis because not having any post-treatment HbA1c values available: * 1 patient under placebo who prematurely stopped before Week 4 * 1 patient under lanifibranor who received 'metformin' as a rescue medication (intercurrent event) before Week 4. Note: Results were similar including this patient in a sensitivity analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: On or after the first dose of treatment up to 30 days post last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanifibranor (800 mg/Day)	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)	1 of 13 (7.7%)	9 of 13 (69.2%)	0 of 13
Placebo	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14

Limitations and caveats (from the sponsor): No multiplicity adjustments when testing for treatment effect on secondary endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for NASH - Nonalcoholic Steatohepatitis

RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
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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.

42 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lanifibranor and Empagliflozin in people with NASH - Nonalcoholic Steatohepatitis and Diabetes Mellitus, Type 2, run by Inventiva Pharma at 42 sites in 5 countries.

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 4 inclusion and 29 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, France, Belgium, United Kingdom, Netherlands. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Absolute Change in HbA1c (time frame: From Baseline to Week 24). 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 NCT05232071.

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 9 Sep 2026.