Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis (NCT NCT03112681)
NCT ID: NCT03112681
Last Updated: 2024-09-19
Results Overview
Change in ALP levels after 16 weeks of Saroglitazar magnesium 2 mg and 4 mg treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Saroglitazar Magnesium 2 mg
Saroglitazar magnesium 2 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 2 mg: Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Saroglitazar Magnesium 4 mg
Saroglitazar magnesium 4 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 4 mg: Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Placebo
Placebo tablet Once daily for 16 weeks
Placebo Oral Tablet: Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
Baseline characteristics by cohort
| Measure |
Saroglitazar Magnesium 2 mg
n=14 Participants
Saroglitazar magnesium 2 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 2 mg: Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=13 Participants
Saroglitazar magnesium 4 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 4 mg: Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Placebo
n=10 Participants
Placebo tablet Once daily for 16 weeks
Placebo Oral Tablet: Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.21 Years
STANDARD_DEVIATION 9.67 • n=99 Participants
|
55.08 Years
STANDARD_DEVIATION 8.00 • n=107 Participants
|
59.20 Years
STANDARD_DEVIATION 7.30 • n=206 Participants
|
57.00 Years
STANDARD_DEVIATION 8.44 • n=7 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Body Mass Index
|
27.71 kg/m^2
STANDARD_DEVIATION 6.39 • n=99 Participants
|
29.62 kg/m^2
STANDARD_DEVIATION 6.49 • n=107 Participants
|
32.30 kg/m^2
STANDARD_DEVIATION 7.37 • n=206 Participants
|
29.62 kg/m^2
STANDARD_DEVIATION 6.77 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Modified intent-to-treat population
Change in ALP levels after 16 weeks of Saroglitazar magnesium 2 mg and 4 mg treatment.
Outcome measures
| Measure |
Saroglitazar Magnesium 2 mg
n=14 Participants
Saroglitazar magnesium 2 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 2 mg: Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=13 Participants
Saroglitazar magnesium 4 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 4 mg: Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Placebo
n=10 Participants
Placebo tablet Once daily for 16 weeks
Placebo Oral Tablet: Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
|
|---|---|---|---|
|
Effect of a 16-week Treatment Regimen of Saroglitazar Magnesium 2 mg and 4 mg on Alkaline Phosphatase (ALP) Levels in Patients With Primary Biliary Cholangitis.
|
-163.82 U/L
Standard Deviation 111.84
|
-162.31 U/L
Standard Deviation 113.98
|
-11.15 U/L
Standard Deviation 27.36
|
Adverse Events
Saroglitazar Magnesium 2 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Saroglitazar Magnesium 4 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saroglitazar Magnesium 2 mg
n=14 participants at risk
Saroglitazar magnesium 2 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 2 mg: Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=13 participants at risk
Saroglitazar magnesium 4 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 4 mg: Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Placebo
n=10 participants at risk
Placebo tablet Once daily for 16 weeks
Placebo Oral Tablet: Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Appendicitis
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
Other adverse events
| Measure |
Saroglitazar Magnesium 2 mg
n=14 participants at risk
Saroglitazar magnesium 2 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 2 mg: Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=13 participants at risk
Saroglitazar magnesium 4 mg tablet Once daily for 16 weeks
Saroglitazar magnesium 4 mg: Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
|
Placebo
n=10 participants at risk
Placebo tablet Once daily for 16 weeks
Placebo Oral Tablet: Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • 16 Weeks
|
15.4%
2/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • 16 Weeks
|
15.4%
2/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
General disorders
Inflammation
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
20.0%
2/10 • 16 Weeks
|
|
Investigations
Hepatic Enzyme increased
|
0.00%
0/14 • 16 Weeks
|
15.4%
2/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Investigations
Transaminase increased
|
14.3%
2/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
20.0%
2/10 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Metabolism and nutrition disorders
Hypervitaminosis D
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
General disorders
Fatigue
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Gastrointestinal disorders
Abdominal distention
|
7.1%
1/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Gastrointestinal disorders
Anal Pruritus
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Appendicitis
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Bacteraemia
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
General disorders
Oedema
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Investigations
Biopsy skin
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Investigations
Liver function test increased
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Nervous system disorders
Sciatica
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Nervous system disorders
Vestibular migraine
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Eye disorders
Blepharal pigmentation
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Eye disorders
Retinal tear
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
10.0%
1/10 • 16 Weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/14 • 16 Weeks
|
7.7%
1/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Renal and urinary disorders
Stress urinary incontinence
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
7.1%
1/14 • 16 Weeks
|
0.00%
0/13 • 16 Weeks
|
0.00%
0/10 • 16 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place