- |||||||||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Monotherapy: ELIVATE: Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis. (clinicaltrials.gov) - Jul 6, 2023 P2, N=235, Completed, The decision to stop the trial early was not because of any safety concerns. Recruiting --> Completed | N=380 --> 235 | Trial completion date: Mar 2024 --> Oct 2022 | Trial primary completion date: Apr 2023 --> Oct 2022
- |||||||||| Synjardy (empagliflozin/metformin) / Boehringer Ingelheim, Eli Lilly, Zynquista (sotagliflozin) / Lexicon Pharma, licogliflozin (LIK066) / Novartis
FAILURE OF SGLT-2 INHIBITOR IN THE CONTEXT OF NEW ILEAL CONDUIT FORMATION () - Mar 28, 2023 - Abstract #ISNWCN2023ISN_WCN_1068; This scenario could be an indication to use dual novel SGLT1/2 inhibitors like sotagliflozin and licogliflozin. More clinical trials are needed to validate this hypothesis.
- |||||||||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Trial completion date, Monotherapy: ELIVATE: Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis. (clinicaltrials.gov) - Apr 28, 2022 P2, N=380, Recruiting, In patients with T2DM, compared with pure SGLT2 inhibitors, combined SGLT1/2 inhibitors demonstrated a lower risk of myocardial infarction and of stroke, but were associated with a higher risk of diarrhea and severe hypoglycemia. Trial completion date: May 2023 --> Mar 2024
- |||||||||| licogliflozin (LIK066) / Novartis
Journal: Licogliflozin effective in PCOS treatment. (Pubmed Central) - Nov 12, 2021 Further studies are needed to clarify their role in weight management. No abstract available
- |||||||||| licogliflozin (LIK066) / Novartis
PK/PD data, Preclinical, Journal: Pharmacokinetics, Metabolism, and Excretion of Licogliflozin, a Dual Inhibitor of SGLT1/2, in Rats, Dogs, and Humans. (Pubmed Central) - May 15, 2021 In humans, direct glucuronidation to M17 and M27 was the major pathway observed, accounting for ∼38% of the dose in excreta while oxidative metabolism also contributed to >29% of the dose in excreta. Oxidative pathways were predominant in animal species.
- |||||||||| Biomarker, Review, Journal: Discontinued Drugs for the Treatment of Cardiovascular Disease from 2016 to 2018. (Pubmed Central) - Feb 7, 2020
Of these, six candidates (MDCO-216, TRV027, ubenimex, sodium nitrite, losmapimod, and bococizumab) were dropped for lack of clinical efficacy, the other six for strategic or unspecified reasons...Four candidate developments (OPC-108459, ONO-4232, GSK-2798745, and TAK-536TCH) were run without biomarkers, which could be used as surrogate endpoints in the 12 cardiovascular drugs discontinued from 2016 to 2018. This review will be useful for those involved in the field of drug discovery and development, and for those interested in the treatment of cardiovascular disease.
- |||||||||| licogliflozin (LIK066) / Novartis
Enrollment closed: Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients (clinicaltrials.gov) - Sep 26, 2019 P2, N=107, Active, not recruiting, Studies of longer duration and in combination with drugs that have different mechanisms of action are needed to define the role of licogliflozin as a therapeutic option for NASH. Recruiting --> Active, not recruiting
- |||||||||| licogliflozin (LIK066) / Novartis
Trial completion, Trial completion date, Trial primary completion date: Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function. (clinicaltrials.gov) - Feb 7, 2018 P2, N=53, Completed, Trial primary completion date: Nov 2017 --> Mar 2018 | Trial completion date: Nov 2017 --> Mar 2018 Recruiting --> Completed | Trial completion date: Nov 2017 --> Jan 2018 | Trial primary completion date: Nov 2017 --> Jan 2018
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