NAFLDPhase 4NCT05872269
A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
A Phase 4 study testing Saroglitazar in people with NAFLD and Obesity, run by Zydus Lifesciences Limited at 19 sites in India.
Trial summary
A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NAFLD, Obesity, Type 2 Diabetes
- What is being tested?
- Saroglitazar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 19 sitesIndia
- Study dates
- 20 Jul 2023to 10 Jun 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged ≥18 years
- Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
- Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol
- .
- Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening:
- Liver stiffness through transient elastography, an LSM ≥8 kPa OR
- Serum ALT ≥45 U/L
Who cannot join
- Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor
- History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
- Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
- Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
- History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
- Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
- Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
- Pregnant or breast feeding females
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
India19 sites, 19 recruiting
- Recruiting
Gastroplus Digestive Disease Centre
Ahmedabad
Dr. Ravindra Gaadhe
- Recruiting
Mission GastroHospital
Ahmedabad
Dr Chirag Shah
- Recruiting
Artemis Hospital
Gūrgaon
Dr Pawan Raval
- Recruiting
Medanta- TheMedicity
Gūrgaon
Dr Neeraj Saraf
- Recruiting
Malla ReddyNarayanaMultispecialtyHospital
Hyderabad
Dr P Kranthi Kumar
- Recruiting
Osmania GeneralHospital
Hyderabad
Dr B Ramesh Kumar
- Recruiting
Yashoda Hospitals
Hyderabad
Dr B Ravishankar
- Recruiting
CARE CHL -Hospitals (Unit ofConvenient HospitalLtd.
Indore
Dr Sandeep Julka
- Recruiting
S R Kalla MemorialGastro and GenralHospital
Jaipur
Dr Mukesh Kalla
- Recruiting
AIIMS
Khorda
Dr Manas Kumar Panigrahi
- Recruiting
Medanta Hospital
Lucknow
Dr Abhai Verma
- Recruiting
Dayanand MedicalCollege & Hospital
Ludhiāna
Dr Omesh Goyal
- Recruiting
Neurociti Hospital
Ludhiāna
Dr Nitin Shanker Behl
- Recruiting
TNMC & BYL NairCh. Hospital
Mumbai
Dr Shubham Jain
- Recruiting
Shree Siddhivinayak Maternity & Nursing Home
Nashik
Dr Soham Doshi
- Recruiting
Sir GangaramHospital
New Delhi
Dr Naresh Bansal
- Recruiting
Alchemist Hospital
Panchkula
Dr Daksh Khurana
- Recruiting
Fortis Hospital
Rupnagar
Dr Kiran Pal Singh
- Recruiting
BAPS Pramukh Swami Hospital
Sūrat
Dr. Parshottam Koradia
About this study
Official title: A Phase 4, Non-randomized, Multicentre, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) With Comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome)
A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Read the detailed description
The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD).
Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
- Conditions
- NAFLD, Obesity, Type 2 Diabetes, Dyslipidemias, Metabolic Syndrome
- Being tested
- Saroglitazar
- Keywords
- Real World Evidence Study
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Diabetes Mellitus, Type 2, Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaroglitazarDrug
4 Mg Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Saroglitazar 4 mg tablets | Experimental | Oral (once daily ) during 364 days/52 weeks of treatment period. Receives: Drug: Saroglitazar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver stiffness
liver stiffness measurement performed by transient elastography
Measured: Baseline to Week 52
Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Measured: Baseline to Week 52
Secondary outcomes (6)
Change in TG, HDL-C, LDL-C and non HDL-C levels
Measured: Baseline to Week 24 and Week 52
Change in serum ALT value
Measured: Baseline to Week 24 and Week 52
Change in serum AST value
Measured: Baseline to Week 24 and Week 52
Change in serum ALP value
Measured: Baseline to Week 24 and Week 52
Change in body weight
Measured: Baseline to Week 24 and Week 52
Change in BMI
Measured: Baseline to Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start20 Jul 2023
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Deven Parmar, MD,FCP, Study chair, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872269
- Sponsor's protocol ID
- SARO.21.003
- Status last verified
- Feb 2024
- First submitted
- 13 May 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Non-randomized, Multicentre, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) With Comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome)
- ClinicalTrials.gov ID
- NCT05872269
- Acronym / sponsor ID
- SARO.21.003
- Conditions
- NAFLD, Obesity, Type 2 Diabetes, Dyslipidemias, Metabolic Syndrome
- Keywords
- Real World Evidence Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 24 May 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.
A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Detailed description
The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD).
Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saroglitazar 4 mg tablets | Experimental | Drug: SaroglitazarOral (once daily ) during 364 days/52 weeks of treatment period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients aged ≥18 years
- Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
- Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol
- .
- Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening:
Key exclusion criteria (8 listed)
- Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor
- History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
- Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
- Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
- History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
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 |
|---|---|---|
| Saroglitazar4 Mg Oral Tablet | Drug | Saroglitazar 4 mg tablets |
Primary outcome
Change in liver stiffness
Time frame: Baseline to Week 52
liver stiffness measurement performed by transient elastography
Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
Time frame: Baseline to Week 52
6 secondary outcomes
Change in TG, HDL-C, LDL-C and non HDL-C levels
Time frame: Baseline to Week 24 and Week 52
Change in serum ALT value
Time frame: Baseline to Week 24 and Week 52
Change in serum AST value
Time frame: Baseline to Week 24 and Week 52
Change in serum ALP value
Time frame: Baseline to Week 24 and Week 52
Change in body weight
Time frame: Baseline to Week 24 and Week 52
Change in BMI
Time frame: Baseline to Week 24 and Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for NAFLD
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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.
Dr. Deven Parmar, MD,FCP study chair
Zydus Therapeutics Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saroglitazar in people with NAFLD and Obesity, run by Zydus Lifesciences Limited at 19 sites in India.
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 7 inclusion and 8 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in India. 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?
Contact Dr Kevin Kansagra, MD (02717-665555 ext. 451, kevinkumarkansagra@zyduslife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver stiffness (time frame: Baseline to Week 52). 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 7 Feb 2024.