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Primary Biliary CholangitisPhase 3NCT06427395

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

A Phase 3 study testing Saroglitazar Magnesium 1 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 28 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Biliary Cholangitis
What is being tested?
Saroglitazar Magnesium 1 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
28 sitesin 3 countries
Study dates
16 Jul 2024to 18 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Must provide written informed consent and agree to comply with the trial protocol
  • Participated and completed SARO.21.001, the double-blind treatment phase study

Who cannot join

  • Consumption of 2 standard drinks per day if male and 1 standard drink per day if female for 3 consecutive months (12 consecutive weeks) throughout double-blind phase till screening.
  • Participants with MELD 3.0 score of 15 or greater
  • History or presence of other concomitant liver diseases at screening:
  • Chronic hepatitis B or C virus (HBV, HCV) infection
  • Primary sclerosing cholangitis (PSC)
  • Alcoholic liver disease
Show all 38Show fewer
  • Autoimmune hepatitis (AIH)-PBC overlap syndrome
  • Hemochromatosis
  • Non-alcoholic steatohepatitis (NASH) on historical biopsy
  • Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites, encephalopathy, history of variceal bleeding or history of hepatorenal syndrome at screening.
  • Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)
  • Use of other PPAR agonists (i.e., Elafibranor, Seladelpar), Obeticholic acid (OCA), methotrexate, budesonide and other systemic corticosteroids (Prednisone dose more than 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening)
  • History of bowel surgery (gastrointestinal [bariatric] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) or listed for OLT
  • Unstable cardiovascular disease, including:
  • Unstable angina, (i.e., new or worsening symptoms of coronary heart disease in the 12 weeks before screening and throughout the screening period), acute coronary syndrome in the 24 weeks before screening and throughout the screening period, acute myocardial infarction in the 12 weeks before screening and throughout the screening period or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period
  • History/current unstable cardiac dysrhythmias
  • Uncontrolled hypertension at screening
  • Stroke or transient ischemic attack in the 24 weeks before screening
  • History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, and coagulation disorders
  • An uncontrolled thyroid disorder
  • Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism that has either not been treated with either radioactive iodine and/or surgery or that has been treated with radioactive iodine and/or surgery, but has required ongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening
  • Uncontrolled hypothyroidism: defined as initiation of thyroid hormone replacement therapy or dose adjustment of replacement therapy in the 12 weeks before screening
  • History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 × ULN at screening
  • Any of the following laboratory values:
  • Total bilirubin > 3 x ULN
  • Platelets < 50 × 103/mL
  • Albumin < 2.8 g/dL
  • eGFR < 45 mL/min/1.73 m2
  • ALT or AST > 250 U/L
  • ALP > 10 × ULN
  • Participation in another interventional clinical study and receipt of any other investigational medication or medical device within 30 days or within 5 half-lives, whatever is longer, prior to screening
  • History of malignancy in the past 5 years and/or active neoplasm which may diminish life expectancy (except resolved superficial non-melanoma skin cancer, carcinomas in situ or other stable, relatively benign conditions if appropriately treated prior to screening)
  • Known allergy, sensitivity or intolerance to the study medication or formulation ingredients
  • Pregnancy-related exclusions, including:
  • Pregnant/lactating female (including positive pregnancy test at screening)
  • Participants agree to avoid pregnancy either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance.
  • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption)
  • Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above at screening (Refer Appendix 11

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

United States17 sites

  • Zydus US022

    Aurora, Colorado, 80045

  • Zydus US002

    Charlotte, North Carolina, 28204

  • Zydus US016

    Charlottesville, Virginia, 22908

  • Zydus US042

    Houston, Texas, 77030

  • Zydus US001

    Indianapolis, Indiana, 46202

  • Zydus US027

    Jacksonville, Florida, 32224

  • Zydus US006

    Lakewood Rch, Florida, 34211

  • Zydus US013

    Los Angeles, California, 90048

  • Zydus US020

    Marietta, Georgia, 30060

  • Zydus US005

    Miami, Florida, 33136

  • Zydus US031

    Murray, Utah, 84107

  • Zydus US037

    New Haven, Connecticut, 06520

  • Zydus US011

    Pasadena, California, 91105

  • Zydus US039

    Richmond, Virginia, 23298

  • Zydus US035

    Rochester, New York, 14642

  • Zydus US043

    Sacramento, California, 95817

  • Zydus US033

    Seattle, Washington, 98105

Other trials in United States

Argentina6 sites

  • Zydus AR001

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1118AAT

  • Zydus AR007

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB

  • Zydus AR006

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1221ADC

  • Zydus AR005

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425BGC

  • Zydus AR003

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1430CKE

  • Zydus AR004

    Pilar, Buenos Aires, B1629ODT

Other trials in Argentina

Turkey (Türkiye)5 sites

  • Zydus TR016

    Altındağ, 06230

  • Zydus TR004

    Ankara, 06800

  • Zydus TR005

    Bursa, 16059

  • Zydus TR017

    Cebeli, 06620

  • Zydus TR015

    Melikgazi, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis (PBC)

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Read the detailed description

A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)

Being tested
Saroglitazar Magnesium 1 mg
Keywords
Saroglitazar Magnesium, Primary Biliary Cholangitis, PBC
Medical subject headings
Liver Cirrhosis, Biliary

What participants receive

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

  • Saroglitazar Magnesium 1 mgDrug

    Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in the open label extension program

Study groups in NCT06427395
Study groupRoleWhat they receive
Saroglitazar Magnesium 1 mgExperimentalSaroglitazar Magnesium 1 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 months).
Receives: Drug: Saroglitazar Magnesium 1 mg

What is being measured

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

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: From baseline to 24 Months/EOT

Secondary outcomes (21)

  1. Proportion of participants achieving biochemical response based on the composite endpoints of ALP and total bilirubin

    ALP < 1.67 x ULN, ≥ 15% decrease in ALP, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN relative to baseline in participants with known Gilbert's syndrome

    Measured: From baseline to Months 12 and 24/EOT

  2. Proportion of participants with biochemical response based on the composite endpoints of ALP and total bilirubin

    complete normalization of ALP. Change and percent change from baseline in ALP

    Measured: From baseline to Months 12 and 24/EOT

  3. Time to occurrence of the clinical outcome events in study participants with PBC

    Defined as new onset or recurrence of any of the following:

    • Hospitalization for new onset or recurrence of variceal bleed
    • Hepatic encephalopathy (as defined by a West Haven score ≥2)
    • New onset ascites requiring treatment
    • Refractory ascites (requiring large volume paracentesis)
    • Spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)

    Measured: From baseline to 24 Months/EOT

  4. Time to occurrence of the clinical outcome events based on Model for End Stage Liver Disease 3.0 score

    Time from enrolment to the first occurrence of Model for End Stage Liver Disease 3.0 score ≥ 15 and 25% increase from baseline as measured on 2 consecutive occasions performed at least two weeks apart with no competing etiologies identified

    Measured: From baseline to 24 Months/EOT

  5. Time to first occurrence of Liver transplant or placement on a liver transplant list

    Measured: From baseline to 24 Months/EOT

  6. Time to the occurrence of Death

    Death (liver and non-liver related)

    Measured: From baseline to 24 Months/EOT

  7. Effect on liver enzyme parameters

    Change from baseline in ALT

    Measured: From baseline to Months 12 and 24/EOT

  8. Effect on liver enzyme parameters

    Change from baseline in AST

    Measured: From baseline to Months 12 and 24/EOT

  9. Effect on liver enzyme parameters

    Change from baseline in GGT

    Measured: From baseline to Months 12 and 24/EOT

  10. Effect on liver enzyme parameters

    Change from baseline in total bilirubin

    Measured: From baseline to Months 12 and 24/EOT

  11. Effect on lipid parameters

    Change from baseline in TG

    Measured: From baseline to Months 12 and 24/EOT

  12. Effect on lipid parameters

    Change from baseline in LDL-C

    Measured: From baseline to Months 12 and 24/EOT

  13. Effect on lipid parameters

    Change from baseline in HDL-C

    Measured: From baseline to Months 12 and 24/EOT

  14. Effect on lipid parameters

    Change from baseline in VLDL-C

    Measured: From baseline to Months 12 and 24/EOT

  15. Effect on lipid parameters

    Change from baseline in total cholesterol

    Measured: From baseline to Months 12 and 24/EOT

  16. Effect on lipid parameters

    Change from baseline in non-HDL-C

    Measured: From baseline to Months 12 and 24/EOT

  17. Effect on liver enzyme parameters

    Change from baseline in serum bile acids

    Measured: From baseline to Months 12 and 24/EOT

  18. Effect on disease-related symptoms

    Change from baseline in quality of life (Primary Biliary Cholangitis- 40) questionnaire domains Scale as Never, Rarely, Sometimes, Most of the time, and Always

    Measured: From baseline to Months 12 and 24/EOT

  19. Effect on disease-related symptoms

    Change from baseline in 5-D itch scale Score ranging from 5 to 25, where higher score represents worst itching

    Measured: From baseline to Months 12 and 24/EOT

  20. Effect on disease-related symptoms

    Change from baseline in Worst Itch NRS (numerical rating scale) scores 0-10, where 0 is no itch and 10 is worst itch imaginable

    Measured: From baseline to Months 12 and 24/EOT

  21. Effect on liver stiffness measurement (LSM) assessed by Liver elastography/FibroScan

    Change from baseline in LSM assessed by Liver elastography/FibroScan

    Measured: From baseline to Months 12 and 24/EOT

Timeline

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

  1. First posted23 May 2024
  2. Study start16 Jul 2024
  3. Primary completion18 Apr 2027 (estimated)
  4. Study completion18 Jul 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, Open-Label, phase III, safety and efficacy study
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06427395
Sponsor's protocol ID
SARO.23.002
Status last verified
Apr 2026
First submitted
9 May 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saroglitazar Magnesium 1 mg in people with Primary Biliary Cholangitis, run by Zydus Therapeutics Inc. at 28 sites in 3 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 2 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 12 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 28 sites in United States, Argentina, Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: From baseline to 24 Months/EOT). 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 NCT06427395.

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 May 2026.

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