Clinical trial NCT05872269: A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: NAFLD
Obesity
Type 2 Diabetes
Dyslipidemias
Metabolic Syndrome
Keywords: Real World Evidence Study
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged ≥18 years
2. Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
3. Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol

   .
4. 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:

   1. Liver stiffness through transient elastography, an LSM ≥8 kPa OR
   2. Serum ALT ≥45 U/L

Exclusion Criteria:

1. 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
2. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
3. Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
4. Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
5. 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.
6. Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
7. Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
8. Pregnant or breast feeding females

Primary outcomes:
measure: Change in liver stiffness
timeFrame: Baseline to Week 52
measure: Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Change in TG, HDL-C, LDL-C and non HDL-C levels
timeFrame: Baseline to Week 24 and Week 52
measure: Change in serum ALT value
timeFrame: Baseline to Week 24 and Week 52
measure: Change in serum AST value
timeFrame: Baseline to Week 24 and Week 52
measure: Change in serum ALP value
timeFrame: Baseline to Week 24 and Week 52
measure: Change in body weight
timeFrame: Baseline to Week 24 and Week 52
measure: Change in BMI
timeFrame: Baseline to Week 24 and Week 52
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Gastroplus Digestive Disease Centre
city: Ahmedabad
country: India
facility: Mission GastroHospital
city: Gurgaon
country: India
facility: Artemis Hospital
city: Gurgaon
country: India
facility: Medanta- TheMedicity
city: Hyderabad
country: India
facility: Malla ReddyNarayanaMultispecialtyHospital
city: Hyderabad
country: India
facility: Osmania GeneralHospital
city: Hyderabad
country: India
facility: Yashoda Hospitals
city: Indore
country: India
facility: CARE CHL -Hospitals (Unit ofConvenient HospitalLtd.
city: Jaipur
country: India
facility: S R Kalla MemorialGastro and GenralHospital
city: Khorda
country: India
facility: AIIMS
city: Lucknow
country: India
facility: Medanta Hospital
city: Ludhiāna
country: India
facility: Dayanand MedicalCollege & Hospital
city: Ludhiāna
country: India
facility: Neurociti Hospital
city: Mumbai
country: India
facility: TNMC & BYL NairCh. Hospital
city: Nashik
country: India
facility: Shree Siddhivinayak Maternity & Nursing Home
city: New Delhi
country: India
facility: Sir GangaramHospital
city: Panchkula
country: India
facility: Alchemist Hospital
city: Rupnagar
country: India
facility: Fortis Hospital
city: Sūrat
country: India
facility: BAPS Pramukh Swami Hospital
Study officials:
affiliation: Zydus Therapeutics Inc.
name: Dr. Deven Parmar, MD,FCP
role: STUDY_CHAIR
References: