- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial completion date, Trial primary completion date: Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients (clinicaltrials.gov) - Oct 15, 2018 P2, N=20, Recruiting, No abstract available Trial completion date: Sep 2018 --> Dec 2019 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||||||||| Ocaliva (obeticholic acid) / Intercept, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling (clinicaltrials.gov) - Oct 9, 2018 P=N/A, N=45, Recruiting, Trial completion date: Sep 2018 --> Dec 2019 | Trial primary completion date: Jun 2018 --> Jun 2019 Trial completion date: Dec 2018 --> Jul 2019 | Trial primary completion date: Jul 2018 --> Jun 2019
- |||||||||| P2 data, Review, Journal: Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials. (Pubmed Central) - Oct 3, 2018
The past decade has seen an explosion of interest in drug development targeting pathologic pathways in non-alcoholic steatohepatitis, with numerous phase 2 and 3 trials currently in progress. Here, we concisely review the major targets and mechanisms of action by class, summarize results from completed pivotal phase 2 studies, and provide a detailed outline of key active studies with trial data for drugs in development, including obeticholic acid, elafibranor, cenicriviroc and selonsertib.
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial completion, Enrollment change, Trial completion date: Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) (clinicaltrials.gov) - Aug 7, 2018 P2, N=19, Completed, Here, we concisely review the major targets and mechanisms of action by class, summarize results from completed pivotal phase 2 studies, and provide a detailed outline of key active studies with trial data for drugs in development, including obeticholic acid, elafibranor, cenicriviroc and selonsertib. Recruiting --> Completed | N=60 --> 19 | Trial completion date: Dec 2018 --> Jun 2018
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial completion, Trial completion date: AESOP: Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) (clinicaltrials.gov) - Jun 3, 2018 P2, N=77, Completed, Recruiting --> Completed | N=60 --> 19 | Trial completion date: Dec 2018 --> Jun 2018 Active, not recruiting --> Completed | Trial completion date: Jun 2019 --> Mar 2018
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial completion date, Trial primary completion date: OCAPUSH: Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers (clinicaltrials.gov) - Apr 27, 2018 P1, N=40, Recruiting, Active, not recruiting --> Completed | Trial completion date: Jun 2019 --> Mar 2018 Trial completion date: Oct 2017 --> Oct 2019 | Trial primary completion date: Oct 2017 --> Oct 2019
- |||||||||| Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Preclinical, Journal: The PPAR pan-agonist bezafibrate ameliorates cardiomyopathy in a mouse model of Barth syndrome. (Pubmed Central) - Mar 3, 2018 Thus, we demonstrate that bezafibrate has a potent therapeutic effect on preventing cardiac dysfunction in a mouse model of Barth syndrome with obvious implications for treating the human disease. Additional studies are needed to assess the potential benefits of PPAR agonists in humans with Barth syndrome.
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial primary completion date: Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling (clinicaltrials.gov) - Feb 22, 2018 P=N/A, N=45, Recruiting, Additional studies are needed to assess the potential benefits of PPAR agonists in humans with Barth syndrome. Trial primary completion date: Dec 2017 --> Jul 2018
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Phase classification, Enrollment change, Trial primary completion date: COBALT: Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis (clinicaltrials.gov) - Jun 21, 2017 P4, N=428, Recruiting, Based on data from a phase 2 randomized controlled trial of adults with NASH, PDFF estimated by MRI scanners of different field strength and at different sites, accurately classifies grades and changes in hepatic steatosis when histologic analysis of biopsies is used as a reference. Phase classification: P3b --> P4 | N=350 --> 428 | Trial primary completion date: Dec 2022 --> Dec 2024
- |||||||||| bile acid cholic acid (INT-777) / Intercept
Journal: G Protein-Coupled Bile Acid Receptor TGR5 Activation Inhibits Kidney Disease in Obesity and Diabetes. (Pubmed Central) - May 27, 2017 Treatment of diabetic db/db mice with the selective TGR5 agonist INT-777 decreased proteinuria, podocyte injury, mesangial expansion, fibrosis, and CD68 macrophage infiltration in the kidney...Compared with normal kidney biopsy specimens, kidney specimens from patients with established ORG or DN expressed significantly more TGR5 mRNA, and levels correlated with disease progression. Our results indicate that TGR5 activation induces mitochondrial biogenesis and prevents renal oxidative stress and lipid accumulation, establishing a role for TGR5 in inhibiting kidney disease in obesity and diabetes.
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Enrollment open, Trial initiation date: AESOP: Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) (clinicaltrials.gov) - Dec 25, 2014 P2, N=75, Recruiting, N=180 --> 217 | Trial primary completion date: Jan 2014 --> Jan 2018 Not yet recruiting --> Recruiting | Initiation date: Sep 2014 --> Dec 2014
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial primary completion date: OBADIAH1: Obeticholic Acid in Bile Acid Diarrhoea (clinicaltrials.gov) - Jun 19, 2014 P2, N=28, Completed, Recruiting --> Active, not recruiting Trial primary completion date: Oct 2013 --> Jan 2014
- |||||||||| Ocaliva (obeticholic acid) / Intercept
Trial completion, Trial primary completion date: OBADIAH1: Obeticholic Acid in Bile Acid Diarrhoea (clinicaltrials.gov) - Jun 19, 2014 P2, N=28, Completed, Trial primary completion date: Oct 2013 --> Jan 2014 Recruiting --> Completed | Trial primary completion date: Oct 2013 --> Jan 2014
|