Eli Lilly reported positive results from the phase 3 SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo in adults with type 2 diabetes inadequately controlled with diet and exercise alone. Tirzepatide led to...
Endocrinology
Chi-Med Presents Data from Phase 3 SANET-P Study of Surufatinib in Neuroendocrine Tumors
Hutchison China MediTech Limited (Chi-Med) announced positive results from the Phase III SANET-p study, which evaluated surufatinib in treating advanced neuroendocrine tumors. Data were presented as a proffered paper session at the European Society for...
Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Study in Patients with Chronic Kidney Disease and Type 2 Diabetes
Bayer announced the phase 3 FIDELIO-DKD study, evaluating finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), met its primary endpoint. Finerenone significantly reduced the combined primary...
Neurocrine Biosciences Reports Positive Phase II Data for Crinecerfont in Adults with Congenital Adrenal Hyperplasia
Neurocrine Biosciences presented positive results from a phase 2 study of crinecerfont (NBI-74788) in adult patients with classic congenital adrenal hyperplasia (CAH). Data showed meaningful reductions in all three key disease hormone markers after 14 days of...
Recordati and Novartis Announce FDA Approval of Isturisa for Cushing’s Disease
Recordati announced the U.S. FDA has approved Isturisa (osilodrostat) for the treatment of adults with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. Recordati expects Istursia to...
Myovant Reports Positive Data from Phase 3 LIBERTY Extension Study of Once-Daily Relugolix for Uterine Fibroids; NDA Submission Planned for 2020
Myovant announced that the Phase 3 LIBERTY open-label extension study of once-daily, oral relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) met the primary endpoints of response and reduction in menstrual blood loss...
Lexicon Pharma Reports Positive Results from Phase 3 SOTA-EMPA Study for Sotagliflozin in Type 2 Diabetes
Lexicon Pharmaceuticals announced topline data from the Phase 3 SOTA-EMPA study for sotagliflozin (Zynquista) in type 2 diabetes. The topline results showed the trial met the primary endpoint and a key secondary endpoint. SOTA-EMPA was a multicenter, 2:2:1...
U.S. FDA Approves IND for Camurus to Begin Phase 3 Trial of CAM2029 for Acromegaly
Camurus announced the U.S. FDA has accepted an Investigational New Drug (IND) application for approval to initiate a Phase 3 study with CAM2029 once-monthly octreotide subcutaneous depot for treatment of acromegaly. The phase 3 trial is a randomized, double-blind,...
University of Washington Calls for New Paradigm of Type 2 Diabetes Clinical Research
Current treatments for prediabetes or recently diagnosed type 2 diabetes fail to make a lasting impact to beta cells, which ultimately control insulin production and release. University of Washington News reports that efforts to aggressively intervene to roll back the...
Karolinska Institutet & Univ. of Miami Researchers Identify Transplanted Cells in Early Type 1 Diabetes
By the time type 1 diabetes is diagnosed, most of the insulin-producing beta cells have already been destroyed. Now, using an innovative transplantation technique, researchers at Karolinska Institutet and University of Miami Miller School of Medicine have been able to...
U.S. & Israeli Study: Food Preservatives Could Add to Ultimate Diabetes Problem
A recent study published in the Journal Science Translational Medicine offers more evidence that propionic acid increases blood sugar by inducing glycogenolysis and compensatory hyperinsulinemia impairing insulin activity in the body. This is a critical...
Investigator Profile: Nicola Abate, MD
An Endocrinologist with the University of Texas and Bay Area Metabolic Health, he received his medical degree in 1985 from the University of Modena and Reggio Emilia—School of Medicine. He is Professor of Endocrinology, Department of Internal Medicine, at the...