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5 Diseases |  |
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1 Trial |  |
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- || Review, Journal: Recent Advances in Individualized Clinical Strategies for Polycystic Ovary Syndrome: Evidence From Clinical Trials and Emerging Pharmacotherapies. (Pubmed Central) - Feb 7, 2025
This comprehensive approach underscores the importance of tailored treatments in optimizing clinical outcomes and quality of life for women with PCOS. The aim of this review is to highlight recent advancements in the treatment of PCOS through clinical trials and emerging pharmacotherapies, emphasizing the need for individualized and multifaceted treatment approaches.
- || Clinical, Review, Journal: Effects of SGLT-2 inhibitors on clinical and biological hyperandrogenism and menstruation irregularities in patients with polycystic ovary syndrome: A systematic review of randomized trials. (Pubmed Central) - Dec 23, 2024
Sodium-glucose transporter type 2 inhibitors appear to have a potential but variable impact on hormonal parameters in women with polycystic ovary syndrome. However, larger and longer-duration studies are needed to fully elucidate their long-term efficacy in addressing hyperandrogenism and improving overall outcomes in these patients.
- || Clinical, Review, Journal: A Systematic Review on Effect of Sodium-Glucose cotransporter-2 inhibitors on the metabolic and endocrinological profile of patients with Polycystic Ovarian Syndrome. (Pubmed Central) - Sep 23, 2024
Overall, there was improvement in metabolic and endocrine profiles, suggesting a potentially beneficial impact of SGLT2 inhibitors in the management of PCOS. There is a requirement for large extensive clinical trials to demonstrate the efficacy of SGLT-2 inhibitors in PCOS patients.
- |||||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Trial termination, 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) - Dec 26, 2023
P2, N=234, Terminated, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated; The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.
- |||| 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, Sponsor: Novartis Pharmaceuticals
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.
- || licogliflozin (LIK066) / Novartis
Retrospective data, Review, Journal: Dose-dependent efficacy and safety of licogliflozin on obese adults: A systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) - Nov 8, 2022
It reduces body weight significantly. Moreover, it improves glycemic control and other cardiometabolic parameters.
- | licogliflozin (LIK066) / Novartis
Journal: Cu Single Atom Nanozyme Based High-Efficiency Mild Photothermal Therapy through Cellular Metabolic Regulation. (Pubmed Central) - Oct 21, 2022
In this work, Cu SAzyme presents extraordinary multienzyme activities to induce reactive oxygen species (ROS) storm formation, which can damage the existing HSPs in cancer cells. Through a two-pronged strategy of SGLT inhibitor and ROS storm, LIK066-loaded Cu SAzyme shows high efficiency for comprehensive removal of HSPs to realize mild PTT.
- |||| licogliflozin (LIK066) / Novartis
Clinical: https://t.co/SC7XXHCSov - inhibition of both the SGLT 1 and 2 with licogliflozin — is tolerance is going to be an issue? Diarrhea in 77% at 150 mg vs. 43% placebo, which was mostly mild in severity. @NoureddinMD @AlkhouriNaim (Twitter) - Jul 30, 2022
- || licogliflozin (LIK066) / Novartis
Clinical, P2a data, Journal: Licogliflozin for nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a study. (Pubmed Central) - Jul 28, 2022
P2
Studies of longer duration and in combination with drugs that have different mechanisms of action are needed to validate these findings and to define a role of licogliflozin as a therapeutic option for NASH. ClinicalTrials.gov identifier: NCT03205150.
- | Retrospective data, Journal: Effects of Sodium/Glucose Cotransporter 2 (SGLT2) Inhibitors and Combined SGLT1/2 Inhibitors on Cardiovascular, Metabolic, Renal, and Safety Outcomes in Patients with Diabetes: A Network Meta-Analysis of 111 Randomized Controlled Trials. (Pubmed Central) - May 6, 2022
ClinicalTrials.gov identifier: NCT03205150. 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.
- || 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, Sponsor: Novartis Pharmaceuticals
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
- | Retrospective data, Journal: SGLT inhibitors on weight and body mass: A meta-analysis of 116 randomized-controlled trials. (Pubmed Central) - Mar 15, 2022
SGLT inhibitors demonstrated weight reduction benefits in this meta-analysis. Further studies are needed to clarify their role in weight management.
- | 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
Clinical, P2 data, Journal: Licogliflozin versus placebo in women with polycystic ovary syndrome (PCOS): a randomised, double-blind, phase 2 trial. (Pubmed Central) - Oct 22, 2021
Dual inhibition of SGLT1/2 ameliorates hyperinsulinemia and -androgenemia in women with PCOS. Licogliflozin may represent a promising novel treatment option for PCOS.
- || Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, licogliflozin (LIK066) / Novartis
Clinical, Journal: Effects of the dual sodium-glucose linked transporter inhibitor, licogliflozin versus placebo or empagliflozin in patients with type 2 diabetes and heart failure. (Pubmed Central) - Jul 30, 2021
Licogliflozin may represent a promising novel treatment option for PCOS. The reduction in NT-proBNP with licogliflozin suggests a potential benefit of SGLT1 and 2 inhibition in patients with T2DM and heart failure.
- || licogliflozin (LIK066) / Novartis
Clinical, Journal: Glucosuric, renal and hemodynamic effects of a dual inhibitor of SGLT1 and SGLT2, licogliflozin, in patients with chronic kidney disease: a randomized trial. (Pubmed Central) - Jul 11, 2021
The reduction in NT-proBNP with licogliflozin suggests a potential benefit of SGLT1 and 2 inhibition in patients with T2DM and heart failure. Licogliflozin treatment results in significantly increased UGE and favorable changes in urinary electrolytes and hemodynamics in patients with varying degrees of CKD (eGFR≥45 mL/min/1.73 m ).
- || licogliflozin (LIK066) / Novartis
Clinical, Journal: Dose-dependent reduction in body weight with LIK066 treatment in Japanese patients with obesity. (Pubmed Central) - Jun 26, 2021
P2
Dual inhibition of SGLT1/2 with licogliflozin treatment induced a dose-dependent reduction in body weight in Japanese patients with obesity. Treatment with licogliflozin was safe and well tolerated in this study.
- || licogliflozin (LIK066) / Novartis
Clinical, Journal: Investigation and management of stool frequency and consistency associated with SGLT1 inhibition by reducing dietary carbohydrate: a randomized trial. (Pubmed Central) - May 26, 2021
Licogliflozin was generally safe and well tolerated. Loose stool associated with licogliflozin treatment and ingestion of meals can be managed by reducing the carbohydrate content of meals taken with licogliflozin.
- || 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.
- || tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
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) - Jan 19, 2021
P2, N=380, Recruiting, Sponsor: Novartis Pharmaceuticals
Oxidative pathways were predominant in animal species. Trial primary completion date: Mar 2022 --> Apr 2023
- || 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) - Dec 3, 2020
P2, N=380, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Mar 2022 --> Apr 2023 Trial completion date: Apr 2022 --> May 2023
- ||| https://t.co/FCdy5gVf4h #AASLD #TLMdX #Obesity #Diabetes #FattyLiver #NASH #NAFLD #dapagliflozin #saxagliptin @AstraZeneca #QTERN #licogliflozin #tropifexor @Novartis #lanifibranor #inventiva #elafibranor @genfit_pharma #obeticholicacid #OCA @InterceptPharma (Twitter) - Nov 19, 2020
- ||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Enrollment change, 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) - Oct 19, 2020
P2, N=380, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Apr 2022 --> May 2023 N=210 --> 380
- tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
[VIRTUAL] SAFETY AND DRUG-DRUG INTERACTION OF TROPIFEXOR IN COMBINATION WITH LICOGLIFLOZIN IN HEALTHY BUT OVERWEIGHT TO OBESE SUBJECTS IN SUPPORT OF A Ph2b COMBINATION STUDY ELIVATE () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1732;
N=210 --> 380 Study data support the doses selected for the ELIVATE study, a Ph2b trial to assess the efficacy (histology based- primary endpoint), safety and tolerability of TXR and LIK combination therapy compared to each as monotherapy in patients with NASH and stage 2 or 3 fibrosis.
- licogliflozin (LIK066) / Novartis
[VIRTUAL] LIK066 (LICOGLIFLOZIN), AN SGLT1/2 INHIBITOR, IMPROVES MARKERS OF HEPATIC AND METABOLIC HEALTH IN PATIENTS WITH NONALCOHOLIC FATTY LIVER DISEASE: FULL STUDY ANALYSIS OF A 12-WEEK, RANDOMIZED, PLACEBO-CONTROLLED, PHASE 2a STUDY () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1677;
Twelve weeks of licogliflozin treatment leads to dose-dependent improvements in liver injury and metabolic biomarkers. Studies of longer duration and in combination with drugs that have different mechanisms of action will define the role of licogliflozin as a therapeutic option for NASH.
- || licogliflozin (LIK066) / Novartis
Clinical, Journal: Licogliflozin, a Novel SGLT1 and 2 Inhibitor: Body Weight Effects in a Randomized Trial in Adults with Overweight or Obesity. (Pubmed Central) - Sep 18, 2020
Licogliflozin produced significant reductions in body weight versus placebo. However, the magnitude of weight reduction was modest.
- ||| licogliflozin (LIK066) / Novartis
@Novartis Is licogliflozin still being investigated as an anti-obesity medication or is it only progressing as a possible NASH medication? (Twitter) - Sep 12, 2020
- |||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Enrollment open, 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) - Jun 30, 2020
P2, N=210, Recruiting, Sponsor: Novartis Pharmaceuticals
However, the magnitude of weight reduction was modest. Suspended --> Recruiting
- || licogliflozin (LIK066) / Novartis
Clinical, Journal: The effects of licogliflozin, a dual SGLT1/2 inhibitor, on body weight in obese patients with or without diabetes. (Pubmed Central) - May 31, 2020
Licogliflozin treatment (1-84 days) leads to significant weight loss and favorable changes in a variety of metabolic parameters and incretin hormones. Dual inhibition of SGLT1/2 with licogliflozin in the gut and kidneys is an attractive strategy for treating obesity and diabetes.
- |||||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Trial suspension, 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 24, 2020
P2, N=210, Suspended, Sponsor: Novartis Pharmaceuticals
Dual inhibition of SGLT1/2 with licogliflozin in the gut and kidneys is an attractive strategy for treating obesity and diabetes. Recruiting --> Suspended
- |||| tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
Enrollment open, 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) - Mar 1, 2020
P2, N=210, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Suspended Not yet recruiting --> Recruiting | Trial primary completion date: May 2020 --> Mar 2022
- |||| licogliflozin (LIK066) / Novartis
Is @Novartis also excited about the dual SGLT1/2 inhibitor licogliflozin #NASH One trial listed https://t.co/ccL9OpIT1W (Twitter) - Feb 23, 2020
- ||| licogliflozin (LIK066) / Novartis
Trial completion: Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients (clinicaltrials.gov) - Feb 12, 2020
P2, N=107, Completed, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting | Trial primary completion date: May 2020 --> Mar 2022 Active, not recruiting --> Completed
- | 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.
- |||| Pharmacotherapy for NAFLD 1.Selonaertib and Emricasan did not meet outcome end points (disappointing) -Pipeline: cotadutide (GLP-1a), licogliflozin(SGLT1/2i), tropifexor (FXRa), saroglitazar (PPARa),PF#(ACCI) #LiverMtg19 #livertwitter (Twitter) - Nov 12, 2019
- | licogliflozin (LIK066) / Novartis
#licogliflozin could be my new favourite word #LiverMtg19 (Twitter) - Nov 12, 2019
- licogliflozin (LIK066) / Novartis
LIK066 (LICOGLIFLOZIN), AN SGLT1/2 INHIBITOR, ROBUSTLY DECREASES ALT AND IMPROVES MARKERS OF HEPATIC AND METABOLIC HEALTH IN PATIENTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE: INTERIM ANALYSIS OF A 12-WEEK, RANDOMIZED, PLACEBO-CONTROLLED, PHASE 2a STUDY (Hynes Convention Center, Auditorium) - Oct 23, 2019 - Abstract #AASLD2019AASLD_3234;
P2
Twelve weeks of licogliflozin treatment causes dose-dependent improvements in liver biochemistries, HbA1c and liver fat content. 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.
- | 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, Sponsor: Novartis Pharmaceuticals
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
- | tropifexor (LJN452) / Novartis, licogliflozin (LIK066) / Novartis
New P2 trial, 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) - Aug 21, 2019
P2, N=210, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- ||||| licogliflozin (LIK066) / Novartis
Trial termination: A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure (clinicaltrials.gov) - Apr 1, 2019
P2, N=125, Terminated, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Completed --> Terminated; This study terminated prematurely because of slow enrollment
- | licogliflozin (LIK066) / Novartis
Enrollment change: A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure (clinicaltrials.gov) - Oct 16, 2018
P2, N=127, Completed, Sponsor: Novartis Pharmaceuticals
Completed --> Terminated; This study terminated prematurely because of slow enrollment N=497 --> 127
- | licogliflozin (LIK066) / Novartis
Trial completion: A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults (clinicaltrials.gov) - Oct 2, 2018
P2, N=460, Completed, Sponsor: Novartis Pharmaceuticals
N=497 --> 127 Active, not recruiting --> Completed
- | licogliflozin (LIK066) / Novartis
Trial completion: A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity (clinicaltrials.gov) - Sep 27, 2018
P2, N=126, Completed, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Completed
- | licogliflozin (LIK066) / Novartis
Trial completion, Trial completion date, Trial primary completion date: A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure (clinicaltrials.gov) - Sep 6, 2018
P2, N=497, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Recruiting --> Completed | Trial completion date: Nov 2018 --> Jun 2018 | Trial primary completion date: Nov 2018 --> Jun 2018
- | licogliflozin (LIK066) / Novartis
Trial completion: Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome (clinicaltrials.gov) - Jul 10, 2018
P2, N=29, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed | Trial completion date: Nov 2018 --> Jun 2018 | Trial primary completion date: Nov 2018 --> Jun 2018 Recruiting --> Completed
- || licogliflozin (LIK066) / Novartis
Trial completion date, Trial primary completion date: Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients (clinicaltrials.gov) - Jun 15, 2018
P2, N=110, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Trial completion date: Apr 2019 --> Sep 2019 | Trial primary completion date: Apr 2019 --> Sep 2019
- |||| licogliflozin (LIK066) / Novartis
Enrollment open: A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity (clinicaltrials.gov) - Apr 17, 2018
P2, N=130, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Apr 2019 --> Sep 2019 | Trial primary completion date: Apr 2019 --> Sep 2019 Not yet recruiting --> Recruiting
- licogliflozin (LIK066) / Novartis
Trial completion date, Trial primary completion date: Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome (clinicaltrials.gov) - Feb 22, 2018
P2, N=24, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Trial primary completion date: Nov 2017 --> Mar 2018 | Trial completion date: Nov 2017 --> Mar 2018
- |||| 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, Sponsor: Novartis Pharmaceuticals
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