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pradigastat (LCQ908) 5mg/10mg for Fatty Liver

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6, 12 and 24 weeks

Summary

The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD).

Eligible Conditions

Fatty Liver

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6, 12 and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6, 12 and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6, 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24

Secondary study objectives

Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12

Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24

Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6

+6 more

Side effects data

From 2014 Phase 3 trial • 45 Patients • NCT01514461

80%

DIARRHOEA

47%

ABDOMINAL PAIN

40%

VOMITING

33%

NAUSEA

27%

HEADACHE

20%

DIZZINESS

20%

PANCREATITIS

20%

COUGH

20%

TENDONITIS

20%

ARTHRALGIA

13%

ABDOMINAL PAIN UPPER

13%

PYREXIA

13%

PANCREATITIS ACUTE

13%

DYSPEPSIA

13%

GASTROENTERITIS

13%

NASOPHARYNGITIS

13%

DECREASED APPETITE

13%

CHANGE OF BOWEL HABIT

13%

WEIGHT DECREASED

13%

SCIATICA

13%

FATIGUE

STRESS

CHOLELITHIASIS

ALLERGY TO ARTHROPOD STING

UPPER RESPIRATORY TRACT INFECTION

DYSGEUSIA

ASTHENIA

NECK PAIN

CAROTID BRUIT

XANTHOMA

CHEST INJURY

FOOD ALLERGY

GASTROENTERITIS VIRAL

LOCALISED INFECTION

PHARYNGITIS

RHINITIS

TINEA INFECTION

ACNE

GASTROINTESTINAL DISORDER

HYPERGLYCAEMIA

DEAFNESS

ABDOMINAL DISTENSION

BARRETT'S OESOPHAGUS

DENTAL CARIES

DIVERTICULUM

FAECES DISCOLOURED

FREQUENT BOWEL MOVEMENTS

RECTAL HAEMORRHAGE

TOOTHACHE

MUSCLE RUPTURE

RIB FRACTURE

BACK PAIN

DEPRESSION

SKIN LESION

SPORTS INJURY

LETHARGY

DRY MOUTH

LIMB INJURY

FAECES SOFT

SJOGREN'S SYNDROME

CONSTIPATION

POST PROCEDURAL COMPLICATION

HYPOGLYCAEMIA

ENTERITIS

LARYNGITIS

BURSITIS

ANAEMIA

BLEPHARITIS

ROSACEA

NEOPLASM SKIN

RESPIRATORY TRACT INFECTION

MYALGIA

MYOPATHY

INCISIONAL HERNIA

OROPHARYNGEAL PAIN

FLATULENCE

CYST

PAPILLOMA

HOT FLUSH

TOOTH INFECTION

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

LCQ908 20 mg

LCQ908 40 mg

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: pradigastat (LCQ908) 5mg/10mgExperimental Treatment1 Intervention

Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.

Group II: pradigastat (LCQ908) 10mg/20mgExperimental Treatment1 Intervention

Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.

Group III: PlaceboPlacebo Group1 Intervention

Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pradigastat

Not yet FDA approved

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